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FDA Approves Dissolving Sublingual Film for Agitation in Schizophrenia, Bipolar I or II
The US Food and Drug Administration has approved IGALMI™ (dexmedetomidine), a dissolving sublingual film, for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Following the approval, BioXcel Therapeutics is set to launch sublingual dexmedetomidine in the United States in the second quarter of 2022.
Based on data from 2 pivotal randomized, double-blinded, placebo-controlled, parallel group Phase 3 trials, the 120- or 180-µg doses of sublingual dexmedetomidine can be self-administered by patients under the supervision of a health care provider, the pharmaceutical company said in a press release.
“IGALMI™ is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” said CEO of BioXel Therapeutics, Vimal Mehta, PhD.
In both clinical trials, the primary efficacy endpoint was the mean change from baseline at 2 hours after dosing for the Positive and Negative Syndrome Scale-Excited Component (PEC) total score. The secondary endpoint was the earliest time of statistically significant change in PEC total score from baseline for the drug compared with the placebo.
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In the 2 trials, sublingual dexmedetomidine met the primary endpoint at 2 hours after the first dose in patients treated with the 120- and 180-µg doses. The drug also “demonstrat[ed] a rapid onset of action” observed at 20 minutes, meeting the second primary endpoint.
The most common adverse reactions (≥5%) in the 180 µg, 120 µg, and placebo groups, respectively, were somnolence (21.4% and 20.6% vs 4.8%); dry mouth (4.8% and 7.1% vs 0.8%); hypotension (6.3% and 4.8% vs 0%); and dizziness (5.6% and 5.6% vs 0.8%). Sublingual dexmedetomidine did not show any treatment-related serious adverse effects (SAEs) in Phase 3 studies. The company does highlight that there is a possibility of notable side effects, including hypotension, orthostatic hypotension and bradycardia, QT interval prolongation, and somnolence.
“The approval of IGALMI™, a self-administered film with a desirable onset of action, represents a milestone moment. It provides health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option,” said John Krystal, MD, the Robert L. McNeil, Jr, professor of translational research and chair of the Department of Psychiatry at Yale School of Medicine, New Haven, Connecticut.
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