Otsuka, Lundbeck’s PTSD Drug Fails to Win US FDA Panel Support | Company Business News-OxBig News Network

Otsuka Pharmaceutical Co.’s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers’ bid to bring the first new drug for the condition to market in more than two decades.

The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies’ brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn’t been established.

Panelists struggled to make sense of Otsuka and Lundbeck’s supporting evidence, which included one successful study and one in which combining Rexulti with sertraline showed no effect on the symptoms of PTSD.

“I’m looking at these studies and I’m just not convinced the combination offers me as a clinician a new tool in the toolbox,” said Murray Raskind, a psychiatrist at the University of Washington.

The Psychopharmacologic Drugs Advisory Committee’s recommendations aren’t binding, but are often followed by the agency.

FDA Commissioner Marty Makary has repeatedly mentioned PTSD as a condition for which new medicines are needed, specifically for veterans.

“We owe it to that community to review some of the potential therapeutics and get a decision out without any delays,” he said in June.

The drugmakers have been seeking to broaden the approved usage of brexpiprazole, which is currently cleared for treating schizophrenia in adults and adolescents, as well as an an adjunctive therapy to antidepressants in adults with major depressive disorder.

In 2023, the FDA also approved brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer’s disease. The drug was discovered by Otsuka, and the Japanese drugmaker is co-developing it with Lundbeck. 

Post-traumatic stress disorder or PTSD affects about 5% of the population in the US in a given year, according to the companies. It can develop after life-threatening or traumatic events and only two medications — sertraline and paroxetine — are approved in the US to treat it. The drugs’ response rates rarely exceed 60%, and fewer than 30% of patients experience full remission, according to the FDA. 

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