Research & Development
Alkermes submits ALKS 5461 NDA with US FDA for the adjunctive treatment of MDD
17 April 2018 -

Biopharmaceutical company Alkermes plc (Nasdaq:ALKS) said on Monday that it has filed for review the New Drug Application (NDA) for ALKS 5461 with the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD), a condition in which patients exhibit depressive symptoms.

The US FDA's target action date for the NDA of ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) is 31 January 2019, added the company.

ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist and samidorphan, a mu-opioid receptor antagonist. The investigational, once-daily oral medicine acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies, disclosed the company.

Additionally, the US FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued 30 March 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by the company to US FDA.

This NDA filing for ALKS 5461 is based on results from the company's clinical efficacy and safety package with data from 30 clinical trials and 1,500 patients with MDD. ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.

On 16 April 2018, the company will host a conference call at 8:30. ET (13:30 BST) to discuss this update. The conference call may be accessed by visiting its website or by dialing +1 888 424 8151 for US callers and +1 847 585 4422 for international callers.

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