The Dublin, Ireland-based company’s ALKS 5461 once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with MDD for whom standard antidepressant therapies have not worked.
Last Friday, the company said that it received a complete response letter from the FDA, in which the agency said it would require additional clinical data “to provide substantial evidence of effectiveness of ALKS 5641 for the adjunctive treatment of MDD,” according to a press release from the company.
Alkermes said it plans to meet with the FDA to discuss the letter and its potential next steps, and based on that meeting it will decide “whether there is a viable path forward for the ALKS 5461 program,” according to the release.
The company’s move to file an application for ALKS 5461, which it did last April, was seen as a gamble – the drug failed two Phase III trials and managed to succeed only after the company redesigned a third late-stage study.
The application it submitted contained data from more than 30 clinical trials and 1,500 patients with MDD, the company said. It added that during development, “ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.”
Shares in Alkermes have dropped 3.3% today, at $31.98 as of 10:04 a.m. EST.