Drug Receives FDA Approval for Treating Schizophrenia and Bipolar Disorder

April 18, 2022

Medication Zeroes in on Managing Agitation Caused by Both Disorders

BioXcel Therapeutics, a Connecticut-based biotech company, has just announced FDA approval of its lead program dexmedetomidine, a sublingual film that is taken orally. The drug, which will be known as Igalmi, was developed to treat agitation that is associated with schizophrenia and bipolar I or II. The FDA approved the drug by analyzing data taken from two, pivotal randomized, double-blinded, placebo-controlled, parallel-group Phase III trials. The first trial tested Igalmi on 380 patients with varying degrees of schizophrenia. The second trial involved 378 patients with bipolar I or II disorder. The primary endpoint (results) proved to be the same in both studies. The trials used a mean change from baseline in total score in a test named Positive and Negative Syndrome Scale-Excited Component, which measures patients’ agitation two hours after taking the drug. In both trials, the medication met the primary in participants treated with two levels of doses: 120 and 180 micrograms, exhibiting statistically significant improvements from baseline. This is the company’s first drug to receive FDA approval. The next step for Igalmi is commercialization, which is expected later this quarter for the American market. 


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