The FDA wants to prevent the clinics from marketing their stem cell products until they obtain necessary FDA approvals. Credit: flikr/ The US Food and Drug Administration

Alkermes has announced that it has received a Refusal to File letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461.

ALKS 5461 is a once-daily oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.

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A Refusal to File letter is received when the FDA deems an NDA insufficiently complete to conduct a review.

The FDA decision is based on ‘insufficient evidence of overall effectiveness for the proposed indication’, meaning it is unable to carry out a substantive review. It has recommended that Alkermes carries out additional clinical trials before the resubmission of the NDA.

The FDA has also requested that Alkermes conducts a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.

Alkermes said in a statement that it plans to appeal the FDA’s decision, and will request a Type A meeting with the FDA to determine what additional information is required to resubmit the NDA.

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Shares in the company fell by 22% following the announcement.

MDD is a common but serious mood disorder in which patients exhibit depressive symptoms for at least two weeks. An estimated 16.2 million people in the US suffered from MDD in 2016, the majority of whom may not adequately respond to initial antidepressant therapy.

CEO of Alkermes Richard Pops said: “We are extremely disappointed with this decision and the implications for patients in the US suffering from major depressive disorder, a serious disease where there is a clear and urgent need for new treatment options for patients and their families.”

“We strongly believe that the clinical development programme, including data from more than 1,500 patients with MDD, provides substantial evidence of ALKS 5461’s consistent antidepressant activity and a favourable benefit-risk profile.”

Any updates on the drug will be included in Alkermes’ first quarter 2018 financial results disclosures.