FDA Accepts NDA for Investigational Major Depressive Disorder Therapy

Officials with the FDA have 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."

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