The Biden-Harris Administration announced that it has reached agreements for new, lower prices for all 10 drugs selected for negotiations. These negotiated drugs are some of the most expensive and most frequently dispensed drugs in the Medicare program and are used to treat conditions such as heart disease, diabetes, and cancer. The new prices will go into effect for people with Medicare Part D prescription drug coverage beginning January 1, 2026.

If the new prices had been in effect last year, Medicare would have saved an estimated $6 billion, or approximately 22 percent, across the 10 selected drugs. These negotiated prices range from 38 to 79 percent discounts off of list prices. About nine million people with Medicare use at least one of the 10 drugs selected for negotiation. People with Medicare prescription drug coverage are expected to see aggregated estimated savings of $1.5 billion in their personal out-of-pocket costs in 2026. For more detailed information about the negotiated prices please see the Centers for Medicare & Medicaid Services (CMS) Negotiated Prices Fact Sheet - PDF.  

“Americans pay too much for their prescription drugs. That makes today’s announcement historic. For the first time ever, Medicare negotiated directly with drug companies and the American people are better off for it,” said U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra. “Congressional budget estimators (Congressional Budget Office) predicted about $100 billion savings over 10 years from drug negotiations, and a $3.7 billion savings in the first year alone. Today we’re announcing that in our first year of negotiations we are saving Medicare an estimated $6 billion and Americans who pay out of pocket will be saving another $1.5 billion moving forward. Empowering Medicare to negotiate prices not only strengthens the program for generations to come, but also puts a check on skyrocketing drug prices.”

“CMS is proud to have negotiated drug prices for people with Medicare for the first time. These negotiations will not only lower the prices of critically important medications for cancer, diabetes, heart failure, and more, but will also save billions of dollars,” said CMS Administrator Chiquita Brooks-LaSure. “Medicare drug price negotiation and the lower prices announced today demonstrate the commitment of CMS and the Biden-Harris Administration to lower health care and prescription drug costs for Americans. We made a promise to the American people, and today, we are thrilled to share that we have fulfilled that promise.”

As a hypothetical example, a senior with Medicare who takes Stelara pays a 25% coinsurance on the drug which may amount to about $3,400 today for a 30-day supply. When the negotiated price goes into effect in 2026, that same 25% coinsurance would cost the beneficiary about $1,100 before the person reaches the catastrophic cap, after which the beneficiary will pay no more out of pocket on their prescription drugs. A beneficiary’s actual costs will depend on their plan’s benefit design.

In August 2023, HHS announced the first 10 drugs covered under Medicare Part D selected for the first cycle of negotiations.

The selected drugs accounted for $56.2 billion in total Medicare spending, or about 20 percent of total Part D gross spending in 2023. Overall, total Part D gross spending for the 10 selected drugs more than doubled from 2018 to 2022, from about $20 billion to about $46 billion, an increase of 134 percent. Medicare enrollees paid a total of $3.4 billion in out-of-pocket costs in 2022 for these drugs.

“CMS negotiated in good faith on behalf of the millions of people who rely on these 10 drugs for their health and well-being. The new negotiated prices will bring much needed financial relief, affordability, and access,” said Meena Seshamani, MD, PhD, CMS Deputy Administrator and Director of the Center for Medicare. “Throughout the process, we remained true to our commitment to be thoughtful and transparent, meeting publicly with patients, providers, health plans, pharmacies, drug companies and others to help inform the process. We will continue to do so for future cycles. Our team is actively working on the next cycle of negotiations where we will combine what we have learned from this first cycle and apply it in negotiating prices for the next round of up to 15 selected drugs.”

The Office of the Assistant Secretary for Planning and Evaluation (ASPE) also released new data today detailing historic pricing trends of the 10 drugs selected for the first cycle of the negotiation program. The report finds that from 2018 to 2023, list prices increased as much as 55 percent.

CMS will select up to 15 more drugs covered under Part D for negotiation for 2027 by February 1, 2025. CMS will select up to 15 more drugs covered by Part B or Part D for 2028, and up to 20 more Part B or Part D drugs for each year after that, as required by the Inflation Reduction Act.

In addition to these newly negotiated prices, people with Medicare are already experiencing lower drug costs thanks to the Inflation Reduction Act. And, next year, all Medicare Part D enrollees will benefit from a $2,000 out-of-pocket cap on their prescription drug costs, further making prescription drugs more affordable for seniors and people with disabilities.

FOSTER CITY, CA —Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi^® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.

The accelerated approval was based primarily on data from the pivotal placebo-controlled Phase 3 RESPONSE study. In the study, 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12, versus 20% of participants taking placebo. Treatment with Livdelzi led to normalization of alkaline phosphatase (ALP) values, a cholestatic marker that is a predictor of risk for liver transplant and death, in 25% of trial participants at month 12. This change was not seen in any trial participants receiving placebo. Change from baseline pruritus score at month 6 was a key secondary endpoint; patients treated with Livdelzi demonstrated a statistically significant reduction in pruritus compared with placebo.

The FDA approved Livdelzi under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s).

“More people are being diagnosed with PBC, impacting people of varied ages, gender, race and ethnicity. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night,” said Carol Roberts, President, The PBCers Organization. “The availability of a new treatment option that can help reduce this intense itching while also improving biomarkers of active liver disease is a milestone for our community.”

PBC is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans, primarily women, and can cause liver damage and possible liver failure if untreated. The disease currently has no cure.

Livdelzi, an oral, peroxisome proliferator activated receptor (PPAR) delta agonist, or delpar, is positioned to challenge the current PBC standard of care, which falls short for many people who experience inadequate response to treatment, putting them at risk for continued liver damage. Livdelzi has demonstrated a sustained efficacy and safety profile across its robust development program to date, including a capacity to normalize ALP levels for some of the people studied with PBC. Given ALP levels are recognized as an important surrogate marker of disease progression in PBC, providers are shifting to view ALP normalization as a treatment goal.

“People living with PBC have been waiting for treatment advancements for many years. Today’s approval of Livdelzi, with its distinct profile, provides them with an important new option,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to leveraging Gilead’s long-standing expertise in liver disease to bring this promising new treatment to all those who could benefit.”

The RESPONSE study, in addition to other studies including the long-term open-label ASSURE study and prior earlier phase studies, together represent the experience with Livdelzi in more than 500 participants with PBC. Ongoing studies include the confirmatory Phase 3 AFFIRM study, a randomized, placebo-controlled confirmatory study designed to evaluate the effect of Livdelzi on clinical outcomes in people with compensated cirrhosis due to PBC.

In the RESPONSE study, Livdelzi, given alone or in combination with UDCA as an oral, once-daily medicine, reduced key biomarkers of PBC disease and helped reduce pruritus (chronic itch), which is a common symptom that can significantly impair quality of life in people with PBC. Livdelzi is the only medicine to demonstrate statistically significant and durable improvements in both pruritus and markers of cholestasis related to the risk of disease progression in a Phase 3 trial. The primary endpoint of the study was a composite biochemical response at month 12, where biochemical response was defined as achieving ALP less than 1.67-times upper limit of normal (ULN), an ALP decrease of greater than or equal to 15% from baseline, and total bilirubin less than or equal to ULN. ALP normalization (i.e., ALP less than or equal to ULN) at month 12 and change from baseline in pruritus score at month 6 were key secondary endpoints. The most common adverse events (reported in ≥5% of trial participants in the Livdelzi arm and higher compared to placebo) were headache, abdominal pain, nausea, abdominal distension (swelling) and dizziness. There were no treatment-related serious adverse events (SAEs), as determined by the study investigators.

The U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).

“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.”

Allergic reactions happen when a person’s immune system reacts abnormally to a substance that normally does not cause symptoms. Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency. Common allergens that can induce anaphylaxis include certain foods, medications and insect stings. Symptoms usually occur within minutes of exposure and include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness. Epinephrine is the only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection.  

Neffy’s approval is based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products. Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products. Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in the treatment of anaphylaxis. A study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy.

Neffy is a single dose nasal spray administered into one nostril. As with epinephrine injection products, a second dose (using a new nasal spray to administer neffy in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen. Patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.

Neffy comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption of neffy, and patients with these conditions should consult with a health care professional to consider use of an injectable epinephrine product. Neffy also comes with warnings and precautions about use of epinephrine by people with certain coexisting conditions and allergic reactions associated with sulfite.

The most common side effects of neffy include throat irritation, tingling nose (intranasal paresthesia), headache, nasal discomfort, feeling jittery, tingling sensation (paresthesia), fatigue, tremor, runny nose (rhinorrhea), itchiness inside the nose (nasal pruritus), sneezing, abdominal pain, gum (gingival) pain, numbness in the mouth (hypoesthesia oral), nasal congestion, dizziness, nausea and vomiting.

The FDA granted neffy Fast Track designation for this application.  

The FDA granted the approval of neffy to ARS Pharmaceuticals.

BETHLEHEM, PA — B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers.

The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.

Risk Statement: There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function which could be life-threatening.

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. 0.9% Sodium Chloride for Injection USP in E3 is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. Sodium Chloride Injection USP is also indicated as a pharmaceutic aid and diluent for the infusion of compatible drug additives. Product was distributed Nationwide within the United States to domestic distributors.

B. Braun has notified its distributors and customers by an official recall notice sent via certified registered mail and has arranged for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST to arrange for product return.

Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to B. Braun’s Postmarket Surveillance Department by calling 1-833-425-1464.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

BOSTON, MA — Vertex Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) submission for suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor to treat moderate-to-severe acute pain. 

The FDA granted suzetrigine priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025January 30, 2025. Suzetrigine has already been granted FDA Fast Track and Breakthrough Therapy designations for the treatment of moderate-to-severe acute pain.

“Today’s FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients suffering from moderate-to-severe acute pain each year in the U.S.,” said Nia Tatsis, Ph.D., Executive Vice President, Chief Regulatory and Quality Officer at Vertex. “The FDA’s granting of a priority review further reinforces the high unmet need in treating acute pain, and the filing brings us one step closer to our objective of filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.”

"In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain. Too many people today are either undertreated, dealing with negative side effects of currently available therapies or foregoing pain medications altogether for fear of becoming dependent on opioids,” said Scott Weiner, M.D., M.P.H., Vertex Acute Pain Steering Committee Chair, Associate Professor of Emergency Medicine at Harvard Medical School and Attending Emergency Physician in the Department of Emergency Medicine at Brigham and Women’s Hospital. “Prescribers and patients deserve new options."

Suzetrigine (formerly VX-548) is an investigational oral, selective NaV1.8 pain signal inhibitor that is highly selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). NaV1.8 is a genetically validated target for the treatment of pain, and suzetrigine has demonstrated a favorable benefit/risk profile in three Phase 3 studies and two Phase 2 studies in patients with moderate-to-severe acute pain. Suzetrigine also demonstrated positive results and a well-tolerated profile in a Phase 2 study in patients with pain associated with diabetic peripheral neuropathy, a type of chronic peripheral neuropathic pain. Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of pain signal inhibitors that have the potential to provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.

CHICAGO, IL — Today at ADLM 2024 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo), researchers will present data on a novel test that predicts whether Alzheimer's patients are genetically predisposed to side effects from anti-amyloid drugs, a promising new class of Alzheimer's therapeutics. The test could improve outcomes for patients with Alzheimer's by helping to prevent instances of brain swelling or bleeding caused by these drugs.

Just last year, the anti-amyloid drug lecanemab became the first medication ever to receive Food and Drug Administration (FDA) approval for slowing the progression of Alzheimer's. More anti-amyloid drugs have received FDA approval since then, offering much-needed hope to individuals with this condition. At the same time, however, concerns have been raised about the safety of these drugs, with the FDA warning that they can cause brain swelling and/or bleeding. This side effect is known as amyloid-related imaging abnormalities (ARIA), and while it's usually mild, in rare cases, it can lead to death. The risk of ARIA is elevated in those who have particular variants of the gene APOE, which is implicated in many forms of Alzheimer's. The FDA therefore also recommends that patients undergo genetic testing before taking anti-amyloid drugs.

A team of researchers from the medical diagnostics company Revvity's Euroimmun has developed a new PCR-based test that determines if a patient has a high-risk combination of APOE variants (also known as a genotype). This method tests for all six possible APOE genotypes simultaneously, which allows for quicker processing by laboratories and ensures that patients receive results faster. To evaluate the test's performance, the researchers used it to analyze 100 blood samples from Alzheimer's patients and 10 samples from healthy blood donors. The researchers also analyzed the same samples using a CE-IVD-marked APOE test and a method known as bidirectional Sanger sequencing, then compared the results from all three methods. All the results agreed in 110 out of 110 cases, showing that the Revvity's Euroimmun test detects a patient's APOE genotype with 100% accuracy.

"There's been a lot of progress with new [anti-amyloid] drugs approved by the FDA, and as a consequence, diagnostic assays need to be updated to be able to test for the consequences of these drugs," said Dr. Maite Sabalza, senior scientific affairs manager at Revvity's Euroimmun. "There is a need to screen patients before receiving treatment, and if they are [positive for a high-risk APOE genotype], doctors can discuss the possibility of stopping or monitoring the treatment or trying something different."

The team at Revvity's Euroimmun is hopeful that their test will become part of the care Alzheimer's patients receive before taking these drugs.

"We want to help these patients," Dr. Sabalza said.

LONDON and CAMBRIDGE, MA — GSK and Flagship Pioneering, today announced they have entered a collaboration with the goal of discovering and developing a portfolio of future transformational medicines and vaccines, starting in respiratory and immunology.

This alliance brings together GSK's disease area expertise and development capability with Flagship's ecosystem of bioplatform companies, inclusive of its novel modalities and technologies, to make major advances in healthcare.

GSK and Flagship will initially fund up to $150 million upfront to support an exploration phase to identify the most promising concepts for further research and development with Flagship's bioplatform companies. From these explorations, the collaboration aims to identify a portfolio of up to 10 novel medicines and vaccines which will each be subject to an exclusive option by GSK for further clinical development. Under the terms of the agreement, Flagship and its bioplatform companies will be eligible to receive up to $720 million in upfront, development and commercial milestones from GSK, as well as preclinical funding and tiered royalties, for each acquired program.

Tony Wood, Chief Scientific Officer, GSK, said: "Together with Flagship, we will use science and technology to deliver best-in-class innovation at pace. We look forward to partnering with the talented team at Flagship, and their ecosystem of bioplatform companies, to further accelerate our pipeline and discover practice-changing medicines and vaccines for patients."

"Flagship and GSK have a shared focus on delivering breakthrough medicines for patients. This collaboration is the latest example of Flagship's Innovation Supply Chain Partnership model, which is designed to generate transformational medicines together with our pharma partners by leveraging our ecosystem of first-in-category bioplatforms to create a sustainable source of treatments for patients with the greatest unmet needs" said Paul Biondi, General Partner, Flagship Pioneering and President, Pioneering Medicines.

MUMBAI, India and PRINCETON, NJ — Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (FDA) approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata.

Alopecia areata affects around 700,000 people in the United States, and 300,000 have severe alopecia areata.Alopecia often leads patients to self-treat before seeking professional help, driven by dissatisfaction with the slow progress of existing treatments.

"LEQSELVI offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians," said Abhay Gandhi, CEO, North America Business, Sun Pharma. "Our fast-growing dermatology business is excited to add this novel treatment to its portfolio."

Alopecia areata is a common autoimmune disease in which hair loss is thought to occur due to the collapse of immune privilege, leading to the immune system targeting the hair follicles and causing sudden hair loss on the scalp, face and sometimes other areas of the body. LEQSELVI is a new, twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a JAK inhibitor, LEQSELVI interrupts the pathways thought to contribute to hair loss in severe alopecia areata.

"We welcome the approval of LEQSELVI as a significant step for the alopecia areata community," said Nicole Friedland, President and CEO, National Alopecia Areata Foundation (NAAF). "Alopecia areata is an autoimmune disease, with significant physical, emotional and financial impacts that go beyond hair loss. Today's announcement empowers the alopecia community with even more choices, to which NAAF is committed, and provides another important option for those living with severe alopecia areata."

The approval is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with alopecia areata who had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than six months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

"For many people with severe alopecia areata, early intervention with effective treatment is critical," said Natasha Mesinkovska, MD, PhD, Associate Professor and Vice Chair for Clinical Research of Dermatology, University of California, Irvine, and investigator in the LEQSELVI clinical development program. "An oral JAK that delivers proven results will be impactful for the alopecia areata community."

Across the Phase 2 dose-ranging study and Phase 3 randomized, placebo-controlled trials, few patients (3.1%) receiving LEQSELVI 8 mg twice daily were discontinued from the trials due to adverse reactions.¹ In clinical trials, more than 100 people continued taking deuruxolitinib for more than three years.

“We are pleased with the timely approval of LEQSELVI by the U.S. FDA,” said Marek Honczarenko, MD, PhD, Senior Vice President, Head of Development, Sun Pharma. “This validates our team’s capability to effectively bring treatments from research and development to approval in a way that is meaningful for physicians and patients. I want to thank all the investigators and patients for their participation in the clinical trials.”

Princeton, NJ and Deerfield, IL — Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

The sNDA submission is based on data from three randomized clinical trials evaluating the safety and efficacy of brexpiprazole in combination with sertraline in adult patients with PTSD.

The primary endpoint for all three trials was the change from randomization (Week 1) to Week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination therapy versus sertraline plus placebo in patients diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

The trials were randomized, double blind, active-controlled, and Trial 061 (Phase II) and 071 (Phase III) were flexible dose trials, while Trial 072 (Phase III) was a fixed dose trial.¹ In Trial 061 and 071, brexpiprazole in combination with sertraline was associated with a statistically significant reduction (p<0.05) in PTSD symptoms compared to sertraline plus placebo, as measured by the change in the CAPS-5 total score from randomization (Week 1) to Week 10 (primary endpoint). In Trial 072, while the primary endpoint was not met, reductions in PTSD symptoms with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071. Improvements were consistently observed across the Clinical Global Impression Severity (CGI-S) scale and the four CAPS-5 clusters of re-experiencing, avoidance, negative cognition/mood and arousal/reactivity symptoms in Trials 061 and 071.

Across the three randomized trials, the combination of brexpiprazole and sertraline in adult patients with PTSD was generally well-tolerated, and no new safety observations were identified. The safety and tolerability results were consistent with the known profile of brexpiprazole in its approved indications and what has been observed in other clinical trials. The overall incidence of treatment-emergent adverse events (TEAEs) across the three trials was 55.5 percent with brexpiprazole plus sertraline, and 56.2 percent with sertraline plus placebo.²

“Post-traumatic stress disorder is one of the most common mental health disorders in the United States. Approximately 13 million adults in the U.S. have PTSD during a given year, and between seven to eight out of every 100 will experience PTSD at some point in their lives,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. “This is a significant development, and we look forward to continuing our efforts to provide a treatment option that may benefit the millions of patients and caregivers who are impacted by the debilitating effects of PTSD.”

“Brexpiprazole in combination with sertraline could represent an important advancement over current standard of care, and we look forward to working with the FDA in the process of seeking approval of this combination,” said Johan Luthman, Ph.D., executive vice president, Lundbeck Research & Development. “We are grateful to the patients and caregivers who participated in these important trials.”

Arlington, VA — Surescripts® released a new data report that highlights the biggest issues facing care providers, pharmacist prescribing trends and opportunities for patient care teams to continue evolving to meet the needs of patients.

“Barriers that limit health intelligence sharing between clinicians prevent the benefits of an evolving care team, like greater efficiency and more accessible care for patients, from being fully realized,” said Frank Harvey, Chief Executive Officer of Surescripts. “Policies are evolving at the state level to allow pharmacists to provide care at the top of their education and training. While this is a step in the right direction, a truly comprehensive policy shift is still needed to bring reimbursement and access to patient intelligence sharing in line with how care is being delivered today so that we can continue helping healthcare heal itself.”

Key Highlights:

• 85% of pharmacists and 76% of other clinicians (including physicians, physician assistants and nurse practitioners) ranked prescription medication costs as the top issue and 85% of pharmacists and 72% of other clinicians ranked burnout as the second biggest issue.
• Since 2023, a growing number of pharmacists (75%, up from 65% in 2023) and other clinicians (29%, up from 26% in 2023) agree with the statement: "we should allow pharmacists to take on more primary care duties like performing point-of-care testing and diagnostics, managing medications used to treat chronic conditions, and prescribing medications for certain conditions."
• About one-third of pharmacists feel their current position allows them to offer patients all the care they need (36%).
• Unlike other clinicians, more than 8 in 10 pharmacists regard connecting pharmacists and other clinicians with centralized clinical information about their patients as a high priority. (85% of pharmacists and 57% of other clinicians).
• Pharmacists and other clinicians agree that it is somewhat or very difficult to share patient information securely and confidently with other care providers (46% of pharmacists and 31% of other clinicians).
• The top 100 most active pharmacist e-prescribers were responsible for 561,054 new prescriptions nationwide in 2023. Pharmacists in California, New Mexico, and New York accounted for 52.9% of the total nationwide pharmacist-issued e-prescriptions.

Between 2022 and 2023, Surescripts’ analysis shows that e-prescriptions issued by a pharmacist have increased 13% and the number of pharmacists e-prescribing also increased 28.8% in the same timeframe.

“This new data shows that patients are driving demand for pharmacists to provide a broader range of clinical care services closer to home, but they need to be reimbursed for these services and gain access to key patient insights to ensure they can provide better quality, safe and less costly care,” said Shannon Reidt, PharmD, MPH, MS, BCPS, Director Medication Research and Analytics for Surescripts. “Given the primary care provider shortages we are seeing, it’s becoming more critical to advance policies that allow pharmacists to care for patients at the full scope of their education and training – which includes medication management for patients with chronic conditions and provide test-to-treat services for patients for routine illnesses.”