FDA approves BioXcel schizophrenia, bipolar disorder drug

April 7, 2022

The U.S. FDA has approved a new drug from BioXcel used to treat patients with schizophrenia or bipolar I or II disorder. BioXcel’s drug Igalmi was developed using the company’s artificial intelligence platform, marking a big step for the technology in the pharmaceutical industry, according to BioXcel.

Igalmi will be used to reduce the number of agitation episodes that patients with bipolar disorders or schizophrenia experience. The drug is a sublingual film, meaning patients take it by putting a film under their tongue, and can start working to reduce agitation states as soon as 20 minutes after it is taken. 

The treatment was developed using Connecticut-based BioXcel’s AI technology and is expected to hit the U.S. markets by the end of June.

Igalmi’s launch is a sigh of relief for healthcare providers and patients, who have been awaiting treatment for agitation episodes for years. These episodes can look different across patients but include symptoms like physical or mental unease, irritability or uncooperativeness. These states require medical intervention to be settled and can affect up to 25% of the 7.3 million people living in the U.S. who are diagnosed with schizophrenia or bipolar disorders.

For its part, BioXcel noted Igalmi’s potential to provide another choice for patients when it comes to managing agitation episodes.

Vimil Mehta, CEO of BioXcel, noted the drug’s “market-changing potential” and said the approval reflected the company’s mission of bringing medicines to patients using AI.

Igalmi was approved following positive and statistically significant results from two studies, Serenity I and Serenity II. Both studies showed the drug had fast-acting results and low safety risks. No serious adverse effects were recorded in the phase 3 studies despite warning labels of serious side effects including hypotension and somnolence, or sleepiness.