FDA Advisory Panel Rejects Efficacy of New PTSD Treatment Combination
The U.S. Food and Drug Administration (FDA) advisory panel recently made a significant decision regarding the use of a combination drug for treating post-traumatic stress disorder (PTSD). The panel voted 10-1 against the effectiveness of Otsuka Pharmaceutical’s antipsychotic medication, brexpiprazole, when used in conjunction with Viatris’ antidepressant Zoloft (sertraline). This decision was based on the available data, which did not demonstrate the drug’s efficacy in treating adults with PTSD.
This outcome aligns with the assessment provided by FDA staff reviewers earlier in the week. Otsuka had submitted its application based on data from one mid-stage and two late-stage studies comparing the combination treatment to sertraline plus a placebo. However, the drug failed to meet the primary goal of significantly reducing the severity of PTSD symptoms in one of the late-stage trials when compared to sertraline and placebo.
PTSD is a mental health condition that can develop after experiencing or witnessing a traumatic event. It affects approximately 4% of U.S. adults and is often linked to war veterans. However, it can also occur in civilians due to natural disasters, abuse, or other forms of trauma.
One of the panel members, Pamela Shaw, a biostatistician at Kaiser Permanente, emphasized the importance of considering all study results. “We simply cannot negate one negative study and say we are going to approve based on two other positive studies,” she stated.
Otsuka Pharmaceuticals did not immediately respond to requests for comment on the panel’s decision. Despite this, the panel discussed potential side effects associated with long-term use of antipsychotics, such as weight gain and movement disorders. They acknowledged that the combination might still be a viable option for patients who do not respond well to sertraline alone.
Walter Dunn, an assistant clinical professor of psychiatry at the University of California Los Angeles, raised concerns about the balance between the risks and benefits of the combination treatment. “The big question for me is knowing that antipsychotics can cause real problems, especially with long-term use, and the modest benefit that the combination treatment potentially can offer,” he said.
The FDA initially planned to make a decision on Otsuka’s application by February 8 but delayed the process to seek input from the advisory panel. As of now, the agency has not set a new date for action on the drug.
While the FDA typically follows the recommendations of its expert advisers, it is not obligated to do so. If approved, the combination drug would mark the first PTSD treatment to receive U.S. approval in over two decades, following the approvals of Zoloft and GSK’s Paxil.
Brexpiprazole, known under the brand name Rexulti, is currently approved in the United States for treating agitation in patients with Alzheimer’s disease and for adults with major depressive disorder and schizophrenia. The drug is being co-developed by Otsuka and Danish pharmaceutical company Lundbeck.
This decision highlights the rigorous evaluation process that new treatments must undergo before they can be approved for public use. It also underscores the importance of thorough clinical trials and careful consideration of both the benefits and risks associated with new medications.
