29 July 2024: FDA approved ZUNVEYL to treat Alzheimer’s Disease

Alpha Cognition’s oral therapy, ZUNVEYL, received the Food & Drug Administration(FDA) approval for the treatment of mild to moderate Alzheimer’s disease(AD). The novel oral therapy has dual mechanisms that prevent drug absorption in the GI tract, leading to better global function and cognitive outcomes. It is also under development in combination with memantine, to treat moderate to severe Alzheimer's Dementia.

ZUNVEYL is a prodrug of Galantamine and an acetylcholinesterase inhibitor (AChEI) which protects acetylcholine, a neurotransmitter responsible for attention, memory, and motivation. It also acts as an allosteric potentiator?to boost the release of acetylcholine from presynaptic neurons. The unique design addresses tolerability issues and boasts a CNS safety profile without insomnia incidents. Galantamine already has abundant positive long-term outcome data since its FDA approval in 2001, and the prodrug activity helps in avoiding GI absorption, which in turn avoids GI side effects and insomnia.

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Alpha Cognition Chief Executive Officer Michael McFadden stated: “The approval of ZUNVEYL is a pivotal moment in the fight against Alzheimer's disease as it is only the second oral AD treatment to be approved in more than a decade. ZUNVEYL was designed to address a critical need for a tolerable and effective treatment that can potentially enhance patients' daily lives with improved long-term outcomes.”? ZUNVEYL is expected in pharmacies by 2025.

Source: Businesswire