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FDA Approves Bipolar and Schizophrenia Drug
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BioXcel Therapeutics Inc. reported that the U.S. FDA has approved its IGALMI™ (dexmedetomidine) Sublingual Film for use in acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Biopharmaceutical firm BioXcel Therapeutics Inc. (BTAI:NASDAQ), which employs artificial intelligence (AI) methodology to identify and create transformative medicines for applications in neuroscience and immuno-oncology, today announced that "the U.S. Food and Drug Administration (FDA) has approved IGALMI™ (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults."

The company advised that IGALMI is able to be self-administrated as directed by patients under close medical supervision. The firm indicated that it expects to launch IGALM commercially in the U.S. in Q2/22.

Dr. John Krystal, M.D., the Robert L. McNeil, Jr. Professor of Translational Research and Chair of the Department of Psychiatry at Yale School of Medicine stated, "There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for healthcare professionals to treat…The approval of IGALMI, a self-administered film with a desirable onset of action, represents a milestone moment. It provides healthcare teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option."

The company explained that in the U.S. there about 7.3 million people living with schizophrenia or bipolar disorders and noted that around 25% of those diagnosed experience agitation episodes that occur up to 10 to 17 times per year. The firm advised that dealing with these episodes often takes a real toll on afflicted patients, their caregivers, and the healthcare system.

BioXcel Therapeutics' CEO Vimal Mehta, Ph.D. commented, "IGALMI is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom…With this landmark achievement of our first approved drug, we have taken a monumental step toward our mission of bringing transformative medicines in neuroscience to patients using our AI platform."

"We believe IGALMI has significant market-changing potential, and we are excited to execute on our commercial launch plans in the U.S. this quarter," Dr. Mehta added.

The company stated that "the FDA approval of IGALMI is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group Phase 3 trials evaluating IGALMI for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II)." The company indicated that IGALMI successfully met the primary endpoints in both trials. In the two SERENITY studies, IGALMI was shown to deliver an onset of action within 20 minutes along with a high response rate with both the 120 mcg and 180 mcg doses.

BioXcel pointed out that IGALMI is "the first and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder."

The company explained that agitation is a frequently occurring yet hard to manage symptom related to bipolar I or II or schizophrenia. The firm said that early detection and quick intervention to decrease agitation is a key ingredient in deescalating symptomatic aggression when it emerges. The report mentioned that the consensus best-practice guidelines for treating agitation incorporate behavioral calming techniques, verbal de-escalation, and medications that patients agree to accept without being forced.

BioXcel Therapeutics is a biopharma firm based in New Haven, Conn., which utilizes AI principles to develop medicines for use in neuroscience and immuno-oncology. The firm leverages its AI platform to accelerate development and reduce overall investigative pipeline costs. The company focuses primarily on existing approved drugs and/or clinically evaluated product candidates and incorporates big data processing capabilities and proprietary machine learning algorithms to search for new therapeutic indices.

IGALMI (BXCL501) is the firm's first commercial product. IGALMI is formulated as a sublingual dexmedetomidine film which has been approved by the FDA for use in acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The company listed that it is also studying use cases for BXCL501 in treating Alzheimer's disease and major depressive disorder.

BioXcel Therapeutics began the day with a market cap of around $556.2 million with approximately 27.98 million shares outstanding and a short interest of about 6.7%. BTAI shares opened 9% higher today at $21.75 (+$1.87, +9.41%) over yesterday's $19.88 closing price. The stock has traded today between $18.96 and $24.57 per share and closed for trading exactly where it ended yesterday at $19.88 (+$0.00, +0.00%).

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