BioXcel Therapeutics announced the submission of a pre-supplemental New Drug Application (pre-sNDA) meeting package to the U.S. Food and Drug Administration (FDA). This submission supports a potential label expansion for IGALMI for outpatient (at-home) use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.
A pre-sNDA meeting with the FDA is scheduled for August 20, 2025. The primary goal of this meeting is to gain alignment with the FDA regarding the content and format of the planned sNDA submission. The company also aims to reconfirm the FDA's view that its current development plans are a reasonable approach for expanding the label for at-home use of 120 mcg BXCL501.
The company is nearing completion of the SERENITY At-Home Pivotal Phase 3 trial and expects to report topline results this quarter. This regulatory step is crucial for bringing an at-home treatment option to an estimated 23 million annual agitation episodes in the U.S. where no FDA-approved therapies currently exist.
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