FDA Accepts New NDA Submission for ALKS 5461


The NDA acceptance comes just days after the FDA issued a Refusal to File letter to Alkermes for its investigational MDD therapy.

The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for Alkermes once-daily, oral, investigative major depressive disorder (MDD) therapy, ALKS 5461, intended for use in patients with an inadequate response to standard antidepressant treatment.

On April 2, 2018, the FDA issued a Refusal to File letter for the therapy, citing an inability to complete the substantive regulatory review due to insufficient evidence of efficacy. The NDA acceptance follows productive interactions with the FDA in which the company clarified facets of the application, without needing to submit additional data or analyses, according to Alkermes.

"[The] FDA's filing of the ALKS 5461 application is a positive step forward for patients suffering from major depressive disorder, a serious disease where inadequate response to existing antidepressants remains a well-known and significant treatment limitation, and where there have been no new pharmacological treatment approaches in 30 years," Craig Hopkinson, MD, the chief medical officer and senior vice president of Medicines Development and Medical Affairs at Alkermes, said in a statement. "We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients."

In the US, an estimated 16.2 million people suffered from MDD in 2016 with a majority not adequately responding to initial antidepressant therapy. The data submitted by Alkermes for the therapy consists of information from more than 3 clinical trials involving upward of 1500 patients with MDD.

ALKS 5461 has a novel mechanism of action for the adjunctive treatment of MDD, acting as an opioid system modulator. The therapy 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 FDA is expected to make a decision regarding the therapy by January 31, 2019.

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