Trial Profile
A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 03 Jun 2025
Price :
$35
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At a glance
- Drugs Brexpiprazole (Primary) ; Sertraline (Primary)
- Indications Post-traumatic stress disorders
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical Development & Commercialization
Most Recent Events
- 10 Jan 2025 According to Otsuka Pharmaceutical Media Release, the Company announced that the FDA plans to host a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to seek input on issues related to the sNDA for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). A final date for the meeting has yet to be set by the FDA, but it is currently anticipated to occur during the first half of 2025.
- 25 Jun 2024 According to Otsuka Pharmaceutical Media Release, based on results from Trial 061 (Phase II), 071 (Phase III) and Trial 072 (Phase III) was a fixed dose trial, the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned PDFU date February 8, 2025.
- 28 May 2024 According to Otsuka Pharmaceutical Media Release, based on the trial data, Otsuka and Lundbeck submitted a supplemental New Drug Application (sNDA) in April to the U.S. Food and Drug Administration (FDA) for brexpiprazole in combination with sertraline for the treatment of adults living with PTSD.