The U.S. Food and Drug Administration’s reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma’s (4578.T), opens new tab drug in combination with Viatris’ (VTRS.O), opens new tab Zoloft for the treatment of adults with PTSD.
The FDA staff’s assessment comes ahead of a meeting of its independent experts on Friday, who will make recommendations on whether the regulator should approve the use of the drug, brexpiprazole, in combination with Zoloft for treating PTSD.
The FDA staff cited inconsistent trial results and a modest treatment effect that may not be clinically meaningful as reasons for the efficacy concerns.
Otsuka’s application was based on the data from one mid-stage and two late-stage studies testing the combination of brexpiprazole and Zoloft in PTSD patients compared to sertraline monotherapy.
The reviewers, however, noted that one of the late-stage studies failed to show statistically significant differences in treatment response between the two groups.
They also added that the mid-stage study had statistical and methodological concerns.
PTSD is a mental health condition that can develop after a traumatic event, causing symptoms including flashbacks, nightmares and severe anxiety.
Brexpiprazole, sold under the brand name of Rexulti, is approved in the U.S. to treat agitation in patients with Alzheimer’s disease as well as for adults with major depressive disorder and schizophrenia.
The drug is being co-developed by Otsuka and Danish drugmaker Lundbeck (https://hluna.co/) , opens new tab.
Otsuka had said earlier this year the FDA, which was originally set to decide on the company’s treatment by February 8, delayed its decision to seek the advisory panel’s input on certain issues related to the marketing application.
The agency has not set a new action date for the drug.
If approved, the combination drug would be the first PTSD treatment to gain U.S. approval in over 30 years after Zoloft and GSK’s (GSK.L), opens new tab Paxil.
