Potential Label Expansion for Igalmi: Pre-Supplemental New Drug Application Meeting Package Submitted

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BioXcel Therapeutics has submitted a pre-supplemental New Drug Application (pre-sNDA) meeting package to the US 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.¹

Scheduled for August 20, 2025, the pre-sNDA meeting will help BioXcel align with the FDA regarding content and format of their planned sNDA submission for Igalmi. The meeting will also assist BioXcel in reconfirming that the FDA views the current development plans as a reasonable approach to support expanding the label to include outpatient use of 120 mcg Igalmi for the acute treatment of agitation associated with schizophrenia or bipolar disorders in the at-home setting, which was an understanding established during the Type C meeting with the FDA on March 6, 2024.

Igalmi is an investigational, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. Igalmi is the first and only FDA-approved orally dissolving sublingual film for mild, moderate, or severe agitation in patients with schizophrenia or bipolar I or II disorder, administered under the supervision of a health care provider.² It is currently under investigation for the acute treatment of agitation associated with Alzheimer disease dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the outpatient setting. The safety and efficacy of Igalmi for these investigational uses have not been established, but it has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.

“We are on track with our clinical development and regulatory submission plan for BXCL501 (Igalmi),” said Vimal Mehta, PhD, the 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 2 favorable recommendations from the Data Safety Monitoring Board, are nearing completion of the SERENITY at-home pivotal phase 3 trial, and expect to report top-line results from the study this quarter.”¹

The SERENITY at-home phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of Igalmi for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial will evaluate 200 participants with a history of agitation episodes residing at home either alone or with caregivers. Participants self-administer 120 mcg of Igalmi or placebo when agitation episodes occur over a 12-week trial period. Participants or caregivers will complete a modified global impression of severity and a clinical global impression of change 2 hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting.

There are no FDA-approved therapies for the acute treatment of agitation in the outpatient setting. If approved, Igalmi’s use in the outpatient setting could help improve access and outcomes for patients with bipolar disorders or schizophrenia who are experiencing agitation.

References

1. BioXcel Therapeutics submits pre-supplemental new drug application meeting package in support of potential label expansion for Igalmi®. News release. July 21, 2025. https://www.globenewswire.com/news-release/2025/07/21/3118593/0/en/BioXcel-Therapeutics-Submits-Pre-Supplemental-New-Drug-Application-Meeting-Package-in-Support-of-Potential-Label-Expansion-for-IGALMI.html

2. BioXcel Therapeutics announces FDA approval of Igalmi™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. News release. April 6, 2022. Accessed July 21, 2025. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-fda-approval-igalmitm