Industry Briefs

FDA Approves New Antipsychotic, Antidepressant Adjuctive Therapy

Last week H. Lundbeck A/S and Otsuku Pharmaceutical Co. Ltd. received a nod from the FDA for their codeveloped drug Rexulti (brexpiprazole) as an adjunctive therapy for major depressive disorder and as a treatment for schizophrenia. The new pharmacoagent is a dopamine D2 and serotonin 5-HT1A partial agonist. Lundbeck and Otsuku announced that the new pharmacotherapy could hit the market as soon as August.

Phase 3 Trial Finds Antidepressant Pristiq ER Is Ineffective in Youth

Pfizer’s antidepressant Pristiq ER, which received FDA-approval for the treatment of major depressive disorder (MDD) in adults in 2008, will not be receiving approval for such indication in children, at least any time soon.

According to the company, results from a phase 3 trial with 340 youth aged 7 to 17 with MDD showed the antidepressant to be no more effective in children than placebo. The trial was the first of four phase 3 pediatric trials being conducted as part of an FDA postmarketing commitment under the Pediatric Research Equity Act (PREA). This law requires pharmaceutical companies to conduct pediatric studies with recently approved drugs for the same indication for which they were approved in adults. ■