Zunveyl, therapy that may be easier on GI system, wins FDA approval
Oral treatment with 'efficacy of galantamine, hope of better tolerability'
The U.S. Food and Drug Administration (FDA) has approved the oral therapy Zunveyl (benzgalantamine), previously known as ALPHA-1062, to treat mild-to-moderate Alzheimer’s disease.
“The approval of Zunveyl is a pivotal moment in the fight against Alzheimer’s disease as it is only the second oral [Alzheimer’s] treatment to be approved in more than a decade,” Michael McFadden, CEO of Alpha Cognition — Zunveyl’s developer — said in a company press release.
“Zunveyl was designed to [address] a critical need for a tolerable and effective treatment,” McFadden added, and its approval provides “hope to millions of patients, families, and caregivers affected by this devastating disease.”
Alpha is planning to launch the therapy in the U.S. in early 2025.
Tolerability may lie in conversion to galantamine outside digestive system
Zunveyl contains a prodrug of galantamine, meaning that Zunveyl is converted into galantamine after it enters the body. Galantamine has been approved since 2001 as an Alzheimer’s treatment, and was sold under the brand name Razadyne. The brand-name therapy has been discontinued, but generic versions are still available.
FDA approval of Zunveyl was based on bioequivalence studies done in healthy volunteers, which demonstrated that the new prodrug therapy delivers equivalent levels of galantamine to the body as its reference treatment.
As a galantamine prodrug, Zunveyl is thought to work by boosting levels of acetylcholine, which is a neurotransmitter (a brain signaling molecule) that’s involved in processes affecting cognition and memory. A notable distinction between Zunveyl and the original formulation is that Zunveyl isn’t converted into galantamine until after it passes through a patient’s digestive system, which may benefit the treatment’s tolerability profile.
Zunveyl “was uniquely designed to bypass the gut with the potential of minimizing [gastrointestinal] side effects,” said Lauren D’Angelo, Alpha’s chief operating officer.
Nausea, like GI issues seen in less than 2% of adults in bioequivalence studies
The therapy’s prescribing information notes that common side effects of galantamine tablets include nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Across three bioequivalency studies of Zunveyl in healthy adults, less than 1 in 50 participants reported any gastrointestinal issues, and there were no reports of insomnia, which can be another side effect of galantamine.
“We believe that Zunveyl … will make a meaningful difference in the lives of those affected by this debilitating disease,” 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.”
Elaine Peskind, MD, an Alzheimer’s expert at the University of Washington School of Medicine in Seattle, said the newly approved oral treatment “marks a meaningful step forward in improving the quality of life for those living with Alzheimer’s and their families.”
Clinicians, Peskind added, “have always believed in the efficacy of galantamine but have been limited in its use due to tolerability issues. To now have an agent with the efficacy of galantamine, but that also offers the hope of better tolerability, will provide physicians a great option to treat patients.”
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