Posted by Michael Wonder on 10 Apr 2024
Lundbeck and Otsuka submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD
9 April 2024 - Lundbeck and Otsuka have submitted a supplemental new drug application for US FDA review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder in adults.
The sNDA submission is based on previously disclosed results, including data from the two clinical Phase 3 trials (#071 flexible dose trial n=416 and #072 fixed-dose trial (n=553), and the clinical phase II (#061 flexible dose trial n=321). All three trials investigated the treatment of post-traumatic stress disorder in adults treated with brexpiprazole in combination with sertraline versus sertraline plus placebo.
