Alzheimer’s disease (AD) remains a significant public health challenge, affecting millions of people worldwide. The recent Food and Drug Administration (FDA) approval of Alpha Cognition’s Zunveyl (benzgalantamine) as an oral therapy for treating mild-to-moderate Alzheimer’s disease marks a notable advancement in the field. This new treatment offers a novel approach with a dual mechanism of action designed to improve both tolerability and efficacy.
Zunveyl is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), which works by preventing the breakdown of acetylcholine, a crucial neurotransmitter involved in memory and attention. Additionally, Zunveyl functions as an allosteric potentiator, enhancing the release of acetylcholine from presynaptic neurons.
“I am very excited about the approval of Zunveyl, which we believe offers better tolerability for patients with Alzheimer’s disease. We 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,” said Elaine Peskind, MD, the Friends of Alzheimer’s Research Professor of Psychiatry, University of Washington School of Medicine.
“This advancement marks a meaningful step forward in improving the quality of life for those living with Alzheimer’s and their families. As a geriatric psychiatrist specializing in Alzheimer’s disease, I am eager to incorporate this new treatment into our practice and see the positive difference it will make.”
FDA Approval of Zunveyl Based on Positive Clinical Trial Results and High Tolerability
The approval was based on positive results from chemistry, manufacturing, and control information, and data demonstrating the bioequivalence and tolerability of Zunveyl from pivotal clinical studies. These studies compared Zunveyl to galantamine immediate-release tablets and galantamine extended-release capsules. According to the results of all three studies, gastrointestinal adverse events (AEs) were less than 2%, and no insomnia was observed.
Investigators believe Zunveyl acts through two distinct pathways that enhance neurotransmitter activity and protect neuronal health, leading to improved cognitive and functional outcomes. The clinical trials also demonstrated sustained improvements in cognitive function and quality of life over extended periods of treatment.
Minimal AEs were reported in the trial, with the most common including nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Zunveyl is also associated with serious skin reactions, cardiovascular conditions, pulmonary conditions, genitourinary conditions, peptic ulcer disease, and gastrointestinal bleeding.
FDA Approval of Zunveyl Marks Major Advancement in Alzheimer’s Disease Treatment
“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,” stated Michael McFadden, CEO of Alpha Cognition. “We are delighted, as this represents a breakthrough in Alzheimer’s treatment, providing hope to millions of patients, families, and caregivers affected by this devastating disease.”
“We are excited to launch Zunveyl and bring this much-needed treatment option to patients suffering from Alzheimer’s disease,” said Lauren D’Angelo, chief operating officer, of Alpha Cognition. “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. We look forward to collaborating with our partners to ensure a successful rollout and broad accessibility.”
Alpha Cognition’s Zunveyl presents a significant advancement in the treatment of Alzheimer’s disease, providing a novel and more tolerable option for patients and their caregivers. The approval and subsequent launch of Zunveyl represent a hopeful step forward in managing this challenging condition, promising improved quality of life for millions affected by Alzheimer’s disease.
Resource: Business Wire, July 29, 2024
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