BioXcel Therapeutics Reports Preliminary Q2 Net Revenues for IGALMI™ (dexmedetomidine) Sublingual Film

BioXcel Therapeutics, Inc., a company specializing in biopharmaceutical advancements using artificial intelligence, recently shared its preliminary, unaudited financial results for the second quarter ending June 30, 2024. The company reports an estimated net revenue of approximately $1.1 million from sales of IGALMI™ (dexmedetomidine) sublingual film during this period. This figure represents a significant 90% increase from the previous quarter and a 141% rise compared to the same quarter in 2023, marking the highest quarterly revenue since the product's commercial launch.

The substantial revenue growth is attributed to enhanced contracting efforts with psychiatric care clinics and behavioral health facilities, executed by a small but effective commercial team. Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, expressed satisfaction with the positive feedback received from physicians, caregivers, and patients regarding IGALMI™. This drug is used for the acute treatment of agitation related to schizophrenia or bipolar I or II disorder.

Since its commercial debut, BioXcel Therapeutics has focused on building brand equity for IGALMI™ through a targeted market-access strategy. The current indication for IGALMI™ is for institutional settings, where approximately 16 million agitation episodes are estimated to occur annually. The company believes that its market presence could also facilitate potential expansion into the at-home setting. Should BXCL501, another product under investigation, be successfully developed and approved for at-home use, BioXcel estimates an additional 23 million annual agitation episodes could be addressed in this new setting. The company is actively pursuing its SERENITY program to tap into the at-home market while also advancing its TRANQUILITY program, targeting agitation associated with Alzheimer’s dementia.

BioXcel Therapeutics plans to discuss its second-quarter financial results and provide business updates during an earnings conference call, the timing of which will be announced soon.

IGALMI™ (dexmedetomidine) sublingual film is a prescription medication administered under healthcare supervision. It is placed under the tongue or behind the lower lip for the acute treatment of agitation linked to schizophrenia and bipolar I or II disorder in adults. However, its safety and effectiveness beyond 24 hours from the first dose remain unstudied, and it is not known whether IGALMI™ is safe and effective in children.

The medication can cause several serious side effects, such as decreased blood pressure, low blood pressure upon standing, and a slower than normal heart rate, especially in patients with low blood volume, diabetes, chronic high blood pressure, and older age. Patients should be monitored for vital signs and alertness post-administration to prevent falling or fainting. It can also cause heart rhythm changes, sleepiness, withdrawal reactions, and decreased efficacy if used longer than 24 hours. Common side effects noted in clinical studies include drowsiness, a tingling sensation or numbness of the mouth, dizziness, dry mouth, and low blood pressure.

Patients are advised to inform their healthcare provider about their medical history, including heart problems, low potassium or magnesium levels, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver issues. They should also disclose if they are pregnant, breastfeeding, or taking any other medications, including over-the-counter drugs, vitamins, and herbal supplements. Special caution should be taken if the patient is on drugs that lower blood pressure, alter heart rate, or include anesthetics, sedatives, hypnotics, and opioids.

BioXcel Therapeutics encourages reporting negative side effects of prescription drugs to the FDA and provides its contact information for further assistance. The company remains committed to utilizing AI to innovate in neuroscience and immuno-oncology, aiming to repurpose existing drugs and clinically validated candidates through its proprietary machine learning algorithms.