Through a complete response letter, the FDA rejected Otsuka and Lundbeck’s request to approve Rexulti (brexpiprazole) in combination with sertraline for treating adults with post-traumatic stress disorder (PTSD), noting the submitted data didn’t provide enough evidence that the drug is effective.

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced the FDA’s letter on September 20 regarding the companies’ supplemental New Drug Application (sNDA) for the combination treatment. The letter stated that the FDA had completed its review but could not approve the application in its current form, citing a lack of substantial evidence of effectiveness to support approval.

The application for Rexulti in combination with sertraline for adults with PTSD was first accepted for FDA review in

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