Alkermes Initiates NDA Submission Of ALKS 5461 For Major Depressive Disorder

(RTTNews) - Alkermes plc (ALKS), a biopharmaceutical company focused on the central nervous system or CNS, diseases, announced Monday the initiation of its rolling submission of a New Drug Application to the U.S. Food and Drug Administration. The company seeks marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action, for the adjunctive treatment of major depressive disorder or MDD.

The company expects to complete the submission of the NDA for this Fast Track designated medicine by year-end 2017.

ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as a balanced neuromodulator in the brain and represents a novel mechanism of action for the adjunctive treatment of MDD.

At a pre-NDA interaction with FDA in July, the company and FDA agreed upon the proposed content and timing of the ALKS 5461 NDA submission.

In October 2013, the FDA granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.

Elliot Ehrich, Executive Vice President, Research and Development of Alkermes, said, "The initiation of the rolling submission for ALKS 5461 is an important first step in the registration process for ALKS 5461, as we work to bring this potential new medicine to patients suffering from major depressive disorder."