Shares of the company surged 14% following the recent FDA approval of AUVELITY, a medication designed to treat agitation associated with dementia due to Alzheimer’s disease. The announcement, made on Thursday, signifies the second neuropsychiatric indication granted for AUVELITY, which is already recognized for its effectiveness in treating major depressive disorder in adults. This latest approval came after the drug was designated as a Breakthrough Therapy by the FDA and underwent evaluation through Priority Review.
AUVELITY is distinguished by its dual action, targeting NMDA and sigma-1 receptors via its dextromethorphan component. This positions it as a first-of-its-kind treatment for agitation linked to Alzheimer’s disease. The addition of bupropion in its formulation boosts dextromethorphan levels in the bloodstream by inhibiting the cytochrome P450 2D6 enzyme.
The FDA’s decision was bolstered by findings from two pivotal Phase 3 trials: ADVANCE-1 and ACCORD-2. In the ADVANCE-1 trial, which lasted five weeks, AUVELITY showed statistically significant improvements over a placebo in alleviating agitation symptoms, as indicated by the Cohen-Mansfield Agitation Inventory total score at the conclusion of the study. Meanwhile, the ACCORD-2 trial, which involved a long-term randomized withdrawal design, found that patients who continued with AUVELITY experienced a notably longer duration before relapsing into agitation symptoms compared to those who transitioned to a placebo.
Agitation occurs in up to 76% of individuals suffering from Alzheimer’s disease, manifesting in various forms such as restlessness, pacing, and even verbal or physical aggression. This condition impacts over 7 million Americans living with Alzheimer’s.
Throughout the ADVANCE-1 trial, the most frequently reported adverse reactions included dizziness and dyspepsia; notably, the rate of discontinuation due to adverse effects was 1.3%, which aligned with the rate observed in the placebo group.
Over 300,000 patients have received AUVELITY in both clinical trials and real-world settings. Following this important development, the company plans to host a webcast on Friday, May 1, at 8:00 AM Eastern Time, to provide further insights and updates.
