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Under the terms of the Agreement, Teva would acquire worldwide rights to the assets including dexmedetomidine sublingual film for an upfront payment of $57.5 million and up to an additional $67.5 million in contingent payments. These include a range of time-based payments linked to the timing of the pending FDA approval, including potential delays in approval, as well as payments tied to the achievement of specified sales milestones.
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About dexmedetomidine sublingual film (BXCL501)
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist. Dexmedetomidine sublingual film is a proprietary, investigational, orally dissolving film formulation currently under FDA review for at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026.
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About IGALMI®
IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a healthcare provider, which is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI have not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.
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IGALMI IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
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- Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.
- Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.
- Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
- Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.
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The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.
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These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.
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Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.
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Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or [email protected].
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