Alkermes waits FDA’s green light for its investigational depressive disorder treatment

Alkermes will attempt to get new approval from the USFDA for its investigational drug for treating major depressive disorder (MDD).

The company on Wednesday said it has submitted a New Drug Application (NDA) to FDA for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of MDD. As Alkermes said, the NDA submission is based on data from more than 30 clinical trials and more than 1,500 patients with MDD. According to Alkermes, throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.

ALKS 5461 was granted Fast Track status by the FDA in October 2013 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies, the Dublin-based company has noted in its press release.

“ALKS 5461 represents the first potential treatment option with a novel mechanism of action for the treatment of depression in 30 years. We believe its unique pharmacology may provide distinct clinical benefits for the large number of patients who do not get adequate relief from first-line standard antidepressant therapy,” said Elliot Ehrich, Research and Development at Alkermes.

Craig Hopkinson, Chief Medical Officer at Alkermes, said that ALKS 5461 has demonstrated consistent safety, tolerability and antidepressant activity for the adjunctive treatment of major depressive disorder throughout its comprehensive clinical development program.