Axsome Stock Down On FDA's Refusal To File Letter For AXS-14 NDA To Manage Fibromyalgia

(RTTNews) - Shares of Axsome Therapeutics, Inc. (AXSM) were losing around 4 percent in the pre-market trading on the Nasdaq after the firm Monday announced that it has received a Refusal to File or RTF letter from the U.S. Food and Drug Administration for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia.

In response to the FDA's feedback, Axsome plans to conduct an additional controlled trial, which will use a fixed-dose paradigm and a 12-week primary endpoint as requested by the FDA. Axsome anticipates initiating the trial in the fourth quarter of 2025.

Fibromyalgia is a chronic debilitating disorder that causes widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment.

AXS-14 is a highly selective and potent norepinephrine reuptake inhibitor for the management of fibromyalgia and other conditions. AXS-14 is an investigational drug product not approved by the FDA.

In the RTF letter, the FDA states that upon preliminary review, it found that the NDA was not sufficiently complete to permit a substantive review.

According to the biopharmaceutical company focused on central nervous system or CNS disorders, the FDA specifically does not consider the second of the two placebo-controlled trials in the submission to be adequate and well-controlled because its primary endpoint was at 8 weeks and it used a flexible-dose paradigm.

The FDA indicated that the first of the two placebo-controlled trials in the submission, which utilized a 12-week endpoint and a fixed-dose paradigm, is adequate and well-controlled.

The firm added that the agency did not raise any questions relating to the positive results of the studies, both of which met their primary endpoints.

Herriot Tabuteau, Chief Executive Officer of Axsome, said, "The clear feedback provided by the FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine allows us to move expeditiously with the continued development of this important investigational medicine for the approximately 17 million patients in the U.S. living with fibromyalgia. We are well positioned to initiate a new controlled trial that will incorporate the FDA's feedback by the end of 2025."

In the pre-market activity on the Nasdaq, the shares were trading at $107.70, down 3.8%.

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