Company focused on obtaining approval for outpatient (at-home) use of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia
Pre-Supplemental New Drug Application meeting with FDA scheduled for August 20, 2025
BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the submission of a pre-supplemental New Drug Application (pre-sNDA) meeting package to the U.S. Food and Drug Administration (FDA) for IGALMI® in support of a potential label expansion for outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia.
The primary purpose of the pre-sNDA meeting, scheduled for August 20, 2025, is to gain alignment with the FDA regarding the content and format of the planned sNDA submission, which the Company is preparing. Additionally, the Company plans to reconfirm the understanding reached during the Type C meeting with the FDA on March 6, 2024, that FDA views the Company’s current development plans as a reasonable approach to support expanding the label to include at-home (outpatient) use of 120 mcg BXCL501 for the acute treatment of agitation associated with schizophrenia or bipolar disorders in the at-home setting.
“We are on track with our clinical development and regulatory submission plan for BXCL501 (IGALMI®),” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Our clear focus continues to be bringing for the first time to patients an at-home treatment for acute agitation associated with schizophrenia or bipolar disorders. We have received two favorable recommendations from the Data Safety Monitoring Board (DSMB), are nearing completion of the SERENITY At-Home Pivotal Phase 3 trial, and expect to report top-line results from the study this quarter.”
An estimated 23 million annual episodes of agitation associated with bipolar disorders or schizophrenia occur in the at-home setting annually in the U.S 1-3. However, there are no FDA-approved therapies for the acute treatment of agitation in this setting.
Additional information on the SERENITY At-Home trial is included in a corporate presentation in the Investors section of the Company’s website: bioxceltherapeutics.com.