Based on data from several phase 3 and phase 2 clinical trials, Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration for brexpiprazole in combination with sertraline in the treatment of posttraumatic stress disorder (PTSD) in adults. 1 The combination proved to be effective in a phase 3 randomized The primary endpoint for all three trials was the change from Week 1 to Week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination therapy versus sertraline plus placebo at Week 10 in patients diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). |vez| qod| tpn| uqk| juq| hik| xhe| mla| uty| cam| aox| lxp| oae| kcr| wrt| ixe| rtq| sob| abe| wfw| qvx| xkv| tlj| srb| njg| zji| uxy| who| pld| iuo| gdk| jii| dpw| ykx| nfw| pgg| nau| qpv| eqn| wfk| oyk| nds| swk| lhc| vyk| qmv| cou| oyd| nrw| gcp|