The U.S. regulatory issued a refusal to file letter to Alkermes, writing that it can’t review the drug’s application based on “insufficient evidence of overall effectiveness for the proposed indication,” and that the company will need to conduct additional clinical trials if wants to resubmit its NDA.
Dublin-based Alkermes said it “strongly disagrees” with the agency and that it plans to appeal the decision.
“We are extremely disappointed with this decision and the implications for patients in the U.S. suffering from major depressive disorder, a serious disease where there is a clear and urgent need for new treatment options for patients and their families,” CEO Richard Pops said in prepared remarks.
The company’s move to file an application for ALKS 5461 was largely viewed as a gamble across the industry – the drug failed two Phase III trials and managed to succeed after the company redesigned a third late-stage trial.
“We strongly believe that the clinical development program, including data from more than 1,500 patients with MDD, provides substantial evidence of ALKS 5461’s consistent antidepressant activity and a favorable benefit-risk profile,” Pops added.
Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder for whom standard antidepressant therapies have not worked.
ALKS shares fell -19% in pre-market activity today.