Axsome Therapeutics Gains FDA Approval#

Axsome Therapeutics (NASDAQ:AXSM) saw its stock price increase by 14% following the announcement of FDA approval for AUVELITY. This medication is designed to treat agitation associated with dementia due to Alzheimer’s disease.

About AUVELITY#

This approval marks the second use of AUVELITY, which was previously approved for treating major depressive disorder in adults. The drug received the FDA's Breakthrough Therapy designation, which is granted to treatments that show significant promise in early clinical trials, and was evaluated under Priority Review, a process that speeds up the approval of drugs that address unmet medical needs.

AUVELITY works by targeting specific receptors in the brain, namely NMDA and sigma-1 receptors, using its active ingredient dextromethorphan. This makes it a first-in-class treatment for agitation related to Alzheimer’s. Additionally, it includes bupropion, which helps increase the levels of dextromethorphan in the body by inhibiting a liver enzyme known as cytochrome P450 2D6.

Clinical Trial Success#

The FDA's approval is backed by results from two Phase 3 clinical trials: ADVANCE-1 and ACCORD-2. In the ADVANCE-1 trial, which lasted five weeks, AUVELITY showed significant improvement in agitation symptoms compared to a placebo, a substance with no therapeutic effect. The ACCORD-2 trial demonstrated that patients who continued AUVELITY treatment had a longer time before their agitation symptoms returned compared to those who switched to a placebo.

Impact of Agitation in Alzheimer’s Patients#

Agitation affects up to 76% of individuals with Alzheimer’s disease, leading to symptoms like restlessness and aggression. Currently, more than 7 million Americans are living with Alzheimer’s. In the ADVANCE-1 trial, common side effects of AUVELITY included dizziness and upset stomach, with a low discontinuation rate of 1.3%, similar to that of the placebo group.

AUVELITY has already been used by over 300,000 patients in both clinical trials and real-world settings. Axsome Therapeutics will host a webcast on Friday, May 1, at 8:00 AM Eastern Time to discuss this development further.