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Business Update
IGALMI™ Approved by the FDA
On April 6, 2022, BioXcel Therapeutics, Inc. (NASDAQ:BTAI) announced that the U.S. Food and Drug Administration (FDA) has approved IGALMI™ for the treatment of acute agitation associated with schizophrenia or bipolar disorder. IGALMI is the first and only FDA-approved orally dissolving sublingual film for adults with mild, moderate, or severe agitation. IGALMI will be supplied as individual films in 10- and 30-count cartons for both 120 and 180 μg doses.
The basis for the approval comes from the SERENITY I and II Phase 3 trials in which IGALMI demonstrated an onset of action as early as 20 minutes and a high response rate, with both 120 and 180 mg doses achieving the primary endpoint of the mean change in the Positive and Negative Syndrome Scale-Excited Component (PEC) total score at two hours following dosing, as shown in the following image.
The final label allows for two additional doses of IGALMI to be administered at least two hours apart if agitation persists. Dosing is based on the severity of agitation (120 mg for mild or moderate agitation; 180 mg for severe agitation), with lower dosing recommended for those with hepatic impairment or advanced age (≥65 years old). The second/third doses are recommended at half the dose of the initial dose, except for those with hepatic impairment that are already receiving a lower initial dose. The dosage recommendations are shown below (IGALMI prescribing information).
With a commercial launch expected in the second quarter of 2022, BioXcel will be concentrating on approximately 1,700 target institutions with a primary focus on emergency medicine and psychiatry specialties. The company's "Land and Expand" strategy begins with a market entry focused on institutional targeting. This will be followed by market expansion, in which the company will employ a tactical expansion strategy to build brand awareness and engage commercial payers. Lastly, additional approvals in other indications such as Alzheimer's agitation or major depressive disorder will increase target opportunities significantly.
Conclusion
We are very glad to see the approval of IGALMI, which impressively only took a little under three years from the first human trial to submission of an NDA. The company is still working on its pricing strategy, but we anticipate that information when the drug is officially launched later this quarter. We believe everything is coming together for a successful commercial launch and we look forward to updates as the year progresses. We have increased our probability of approval for IGALMI to 100% in our model (up from 95%), which has increased our valuation slightly to $116.
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