FDA Advisory Committee Votes Against Brexpiprazole Indication for Treatment of PTSD Following Efficacy Concerns
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted not to recommend the use of Otsuka and Lundbeck’s brexpiprazole (Rexulti) in combination with sertraline for the treatment of posttraumatic stress disorder (PTSD).
The 10–1 decision comes after FDA reviewers raised concerns about “discordant results” from the drug’s phase 2 and phase 3 randomized, double blind, active-controlled clinical trials. In the phase 2 trial, study 061, and one of the phase 3 trials, study 071, brexpiprazole in combination with sertraline was associated with a statistically significant reduction (p<0.05) in PTSD symptoms compared to sertraline plus placebo.
However, neither of the active treatment groups proved superior to sertraline plus placebo in study 072, a second phase 3 trial in which patients were randomized to 1 of 3 fixed-dose groups: brexpiprazole 2 mg plus sertraline 150 mg, brexpiprazole 3 mg plus sertraline 150 mg, or sertraline 150 mg plus placebo.
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“While study 061 supports the effectiveness that study 071 showed, it really doesn’t offset the discordant findings from study 072,” said Christopher Coffey, PhD, MS, director of the Clinical Trials Statistical and Data Management Center, Edwin B. Green Chair in Public Health, University of Iowa, Iowa City, IA, during Friday’s vote. Other voting members echoed the sentiment, highlighting a need for further data to establish efficacy.
Patient advocate Laura Block, PharmD, was the only member who voted to approve the indication, citing concerns that a lack of FDA approval could make the medication difficult for patients with PTSD to access and afford.
The medication would have been the third FDA-approved treatment for PTSD, along with sertraline and paroxetine.
“Although today’s outcome was disappointing, we remain fully committed to collaborating with the FDA as they complete their review of this application,” said John Kraus, MD, PhD, executive vice president and chief medical officer, Otsuka, in a press release. “We continue to believe in [brexpiprazole’s] potential, in combination with sertraline, to make a meaningful difference as a treatment option for the PTSD patient population.”
