BioXcel Therapeutics Inc. (NASDAQ: BTAI) announced the U.S. Food and Drug Administration has accepted its supplemental new drug application for IGALMI to treat agitation associated with bipolar disorders or schizophrenia in at-home settings. The FDA assigned a target action date of November 14, 2026, under the Prescription Drug User Fee Act.

IGALMI, containing dexmedetomidine, is currently approved for acute treatment of agitation associated with schizophrenia and bipolar disorder in adults under healthcare provider supervision. The supplemental application seeks to expand its use to outpatient settings.

"The regulatory acceptance of our sNDA for IGALMI marks a key milestone in our company's mission to improve the lives of millions of patients suffering from agitation associated with bipolar disorders or schizophrenia, with no FDA approved treatment option for this condition in the at-home setting," said Chief Executive Officer Vimal Mehta.

The company stated the potential approval could address up to 86 million annual episodes of agitation. BioXcel Therapeutics describes itself as a biopharmaceutical company using artificial intelligence to develop neuroscience treatments.

The current approved version of IGALMI is administered as a sublingual film under healthcare provider supervision. Common side effects include sleepiness, mouth numbness, dizziness, dry mouth, and low blood pressure. The drug carries warnings for decreased blood pressure, heart rhythm changes, and withdrawal reactions.

Information in this article is based on a company press release.