2022-04-08| Trials & Approvals

BioXcel Gets FDA Nod for First Oral Sublingual Film for Schizophrenia Treatment

by Aurora Mau
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BioXcel’s IGALMI (dexmedetomidine) received U.S. FDA approval for treating schizophrenia and both I and II bipolar disorder, becoming the first orally dissolving sublingual film for acute treatment for agitation in patients schizophrenia or bipolar I or II disorder in Adults. BioXcel is prepared to launch IGALMI in the U.S. in the second quarter of 2022.


A Revolutionary Drug for Schizophrenia


BioXcel Therapeutics, a biopharmaceutical company, is dedicated to utilizing artificial intelligence (AI) approaches to develop new treatments for neuroscience and immuno-oncology. IGALMI is not only BioXcel’s first approved drug; it is also a milestone for AI-powered drug development in the neuroscience field.

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There are an estimated 7.3 million Americans diagnosed with schizophrenia or bipolar disorders, and up to 25 million agitation episodes are associated with these two mental illnesses annually, thus being challenging for healthcare professionals to treat. With IGALMI being a  self-administrated treatment, it provides clinicians with a novel option to help control patients’ agitation.

“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,” said Vimal Mehta, the CEO of BioXcel Therapeutics. 


Positive and Rapid Therapeutic Effects 


The FDA approval is based on the data from two double-blinded, placebo-controlled, Phase 3 trials, SERENITY I and SERENITY II. IGALMI met the primary endpoint in both trials, showing statistically significant improvements from baseline. 

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

Another similar drug, SYCREST /SAPHRIS (Asenapine) by Merck, provides the acute treatment for schizophrenia in adults and manic or mixed episodes associated with bipolar I disorder. However, it is reported that the extensive hepatic metabolism limits its oral bioavailability, therefore the sublingual film form of asenapine was being investigated to enhance the therapeutic efficacy. With IGALMI being orally dissolving sublingual film, the therapeutic efficacy might provide an alternative option for people suffering with the conditions.


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