Rexulti, a drug jointly developed by Otsuka Pharmaceutical and Lundbeck, is the sole other treatment FDA-approved for Alzheimer's agitation; as an antipsychotic, it comes with the agency's black box warning over elevated mortality risk in elderly dementia patients with psychosis. Auvelity does not carry that warning.
The approval was based on two randomized trials. In the first, a five-week study, Auvelity performed better than placebo on a standardized scale measuring the frequency of agitated behaviors. The second was a withdrawal study in which patients who had responded to the drug were either continued on it or switched to placebo; those who remained on Auvelity took significantly longer to relapse.
Common side effects are dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual problems, and sweating. The drug has a boxed warning about a higher risk of suicidal thoughts and behaviors in adolescents and young adults taking antidepressants, which is also found on other bupropion medicines. It can also cause seizures, high blood pressure, and may trigger mania or hypomania in some people.
"This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer's disease," FDA Commissioner Marty Makary said in a statement.
The FDA granted breakthrough therapy designation and priority review for the application. Axsome said the drug has already been administered to more than 300,000 patients across clinical and real-world settings. Axsome told Reuters the drug carries a uniform list price of $1,248 per month regardless of indication, and the company anticipates making it available for the Alzheimer's agitation use in June.
