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FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD), announced brexpiprazole codevelopers Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S.
The FDA target date for completion of the application’s review is February 8, 2025.
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The submission is based on data from 3 randomized, double-blind trials evaluating the safety and efficacy of brexpiprazole in combination with sertraline in adults with PTSD.
The phase 2 (061) and phase 3 (071) flexible-dose trials found brexpiprazole in combination with sertraline was associated with a statistically significant reduction in PTSD symptoms on the Clinician-Administered PTSD Scale total score, compared with sertraline plus placebo, over 10 weeks. The primary endpoint was not met in the phase 3, fixed-dose trial (072); however, reductions in PTSD symptoms with brexpiprazole in combination with sertraline were consistent with trials 061 and 071.
The combination of brexpiprazole and sertraline was generally well-tolerated, with no new safety observations across the 3 trials. The overall incidence of treatment-emergent adverse events was 55.5% with brexpiprazole plus sertraline and 56.2% with sertraline plus placebo.
“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, PhD, executive vice president of research and development at Lundbeck.
Brexpiprazole received FDA approval in 2015 as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. In 2023, brexpiprazole was approved for the treatment of agitation associated with dementia due to Alzheimer disease.
Brexpiprazole’s mechanism of action is unknown. Its efficacy may be mediated, according to the companies, through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, antagonist activity at serotonin 5-HT2A receptors, and antagonism of alpha 1B/2C receptors.
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