The Food and Drug Administration (FDA) has approved biopharmaceutical company BioXcel Therapeutics’ acute treatment for schizophrenia or bipolar disorder-associated agitation.
BioXcel Therapeutics’ IGALMI (dexmedetomidine) is the first new treatment for schizophrenia or bipolar disorder-associated agitation in almost 10 years, according to the company.
The FDA’s decision was based on data from two pivotal randomised, 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 trials assessed agitation in patients using a Positive and Negative Syndrome Scale-Excited Component (PEC) total score assessed at two hours following dosing. PEC evaluates five elements associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement. The trials showed that patients experienced significant improvements in agitation following 120 mcg and 180 mcg of IGALMI1.
Around 7.3 million people in the US are diagnosed with schizophrenia or bipolar disorders, with a quarter of these people experiencing agitation.2
“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,” said Dr John Krystal, the Robert L. McNeil, Jr. Professor of Translational Research and Chair of the Department of Psychiatry at Yale School of Medicine. “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.”
Vimal Mehta, CEO of BioXcel Therapeutics said: “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 are deeply grateful to our clinical trial participants, healthcare providers, researchers, and employees for contributing to this important new therapy. 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.”