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Biopharma Co. Gains FDA Approval for Oral MDD Drug
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Shares of Axsome Therapeutics Inc. traded 39% higher after the company reported that the U.S. FDA granted approval for its AUVELITY™ making it the first oral N-methyl D-aspartate (NMDA) receptor antagonist authorized for treating major depressive disorder in adults.

Biopharmaceutical firm Axsome Therapeutics Inc. (AXSM:NASDAQ), which is engaged in the development of therapies that utilize a novel mechanism of action to manage and treat central nervous system (CNS) disorders, today announced that "the U.S. Food and Drug Administration (FDA) has approved AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults."

The company stated that "AUVELITY is the first and only rapid-acting oral medicine approved for the treatment of MDD with the labeling of statistically significant antidepressant efficacy compared to placebo starting at one week." Axsome advised that the AUVELITY New Drug Application (NDA) had been evaluated by the FDA under Priority Review status.

Maurizio Fava, M.D., Psychiatrist-In-Chief, Department of Psychiatry, Massachusetts General Hospital, Executive Director, Clinical Trials Network & Institute, Associate Dean for Clinical & Translational Research, and Slater Family Professor of Psychiatry, Harvard Medical School stated, "The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile. Auvelity, which was granted Breakthrough Therapy designation by the FDA, represents the first new oral non-monoamine-based mechanism of action approved to treat major depressive disorder in over sixty years."

Dan V. Iosifescu, M.D., Professor of Psychiatry at the New York University School of Medicine and Director of the Clinical Research Division at the Nathan Kline Institute for Psychiatric Research, commented, "Major depressive disorder is disabling and potentially life-threatening, causes profound distress for patients and their families and leads to substantial healthcare resource utilization. Auvelity's oral NMDA receptor antagonist and sigma-1 receptor agonist activity, which targets glutamatergic neurotransmission, provides clinicians a long sought-after new mechanistic approach which may benefit the millions of patients living with this serious condition."

The company noted that AUVELITY had undergone analysis in a comprehensive clinical program that enrolled greater than 1,100 patients diagnosed with depression. In the firm's GEMINI study, AUVELITY statistically and significantly met its primary endpoint where it demonstrated improvement of depressive symptoms versus placebo as measured by changes in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score at week six.

Subsequently, the company moved forward into a confirmatory ASCEND study which was designed to compare AUVELITY to bupropion sustained-release tablets. The ASCEND study was structured to assess weekly changes from baseline reading in MADRS scores over six weeks.

The company's CEO Herriot Tabuteau, M.D., remarked, "The approval of Auvelity is the culmination of the tremendous and focused research and development activities conducted by the Axsome team and our collaborators. We are extremely proud to deliver this Breakthrough Therapy-designated new treatment to the millions of patients living with depression at a time when it is most needed, given the recent sharp increase in depression prevalence."

"We are thrilled to contribute to potentially fundamental advances in neuropsychiatry by providing clinicians the first rapid-acting oral antidepressant demonstrated with FDA labeling and the first oral glutamatergic medicine approved for depression," Dr. Tabuteau added.

Axsome Therapeutics indicated that when AUVELITY is launched commercially starting in Q4/22, it will roll out a series of programs to assist doctors and patients, including a samples program, prior authorization support, and patient support tools. In addition, the firm advised that it plans to initiate a patient support program to make treatment more affordable for eligible commercially insured patients.

The company explained that "major depressive disorder (MDD) is a debilitating, chronic, biologically-based disorder characterized by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms." MDD is known to impair a person's ability to function in social, educational, and workplace situations and throughout almost all aspects of people's daily lives and, in severe cases, may result in suicide. The firm listed that each year there are approximately twenty-one million people in the U.S. who experience MDD.

The report listed that "AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults." In March of 2019, the medicine was assigned Breakthrough Therapy designation from the FDA for use in treating MDD.

Axsome Therapeutics is a biopharmaceutical firm based in New York, NY, that is focused on developing novel therapies for use in treating central nervous system (CNS) conditions that at present have only limited treatment options. The company's efforts are concentrated on the discovery of new therapeutic options with novel mechanisms of action. Axsome's ongoing product development pipeline includes potential treatments for major depressive disorder (MDD), agitation associated with Alzheimer's disease, acute migraine, fibromyalgia, smoking cessation, and narcolepsy.

Axsome Therapeutics started off the day with a market cap of around $1.65 billion with approximately 38.91 million shares outstanding and a short interest of about 14.75%. AXSM shares opened 22% higher today at $51.89 (+$9.46, +22.30%) over yesterday's $42.43 closing price and reached a new 52-week high price this morning of $61.11. The stock has traded today between $50.50 and $61.11 per share and is currently trading at $58.88 (+$16.45, +38.77%).

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