Axsome Therapeutics is developing Auvelity as a treatment for Alzheimer’s disease agitation. While one Phase 3 trial showed statistically significant results, another did not meet that threshold, prompting questions about FDA approval. Auvelity has shown promise as a safer alternative to the currently approved drug, Rexulti, which carries significant safety risks. Despite concerns about efficacy, the positive safety profile of Auvelity may appeal to the FDA. Analysts believe that regulatory flexibility may be needed to approve Auvelity, as the drug addresses a significant unmet need in the treatment of Alzheimer’s agitation. Further studies and discussions with the FDA are expected to determine the drug’s future prospects.
Source link
Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data
