Formerly known as ALPHA-1062, the therapy is said to have a dual mechanism of action aimed at improving tolerability and maintaining the efficacy of galantamine, its active moiety.
The FDA’s approval of ZUNVEYL was based on comprehensive chemistry, manufacturing, and controls information.
It also included data demonstrating bioequivalence and tolerability when compared to existing galantamine immediate-release tablets and extended-release capsules.
Notably, the trials reported minimal adverse events.
The efficacy of ZUNVEYL is supported by three bioavailability studies in healthy adults.
These studies compared the therapy to both immediate-release tablets and extended-release capsules of galantamine.
The gastrointestinal adverse events documented for ZUNVEYL were less than two percent, and no cases of insomnia were reported.
Clinical trials have shown that galantamine, the active component of ZUNVEYL, provides sustained improvements in cognitive function and quality of life over extended periods of treatment.
ZUNVEYL is set to be available by prescription in pharmacies across the nation starting in the first quarter of next year.
Alpha Cognition CEO Michael McFadden said: “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 addresses a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes.”
Alpha Cognition chief operating officer Lauren D’Angelo said: “Over the coming months, our team will work diligently to prepare for this launch, ensuring that healthcare providers have the information and patients have the resources and support they need.
“ZUNVEYL offers dual-action benefits with the established efficacy of galantamine and no insomnia. It was uniquely designed to bypass the gut with the potential of minimizing GI side effects. We believe that ZUNVEYL’s unique combination of these attributes will make a meaningful difference in the lives of those affected by this debilitating disease.”