FDA Approves Oral Alzheimer’s Drug

The FDA has approved the oral therapy Zunveyl (benzgalantamine) to treat patients with mild-to-moderate Alzheimer’s disease. Alzheimer’s disease is a type of dementia that impacts almost 7 million people in the United States.

Developed by Alpha Cognition, Zunveyl is a prodrug of galantamine, a acetylcholinesterase inhibitor (AChEI) that is used manage Alzheimer’s disease by increasing acetylcholine levels in the brain and improving cognitive function and memory. About 80% of patients with Alzheimer’s disease are prescribed acetylcholinesterase inhibitors, but many stop their treatment because of side effects, especially gastrointestinal side effects.

Zunveyl was developed to address the gastrointestinal side effects associated with galantamine, including loss of appetite, nausea, vomiting, diarrhea, and weight loss.

Zunveyl will be available in the first quarter of 2025. Company officials said they will release pricing information in the fourth quarter of 2024. A company spokesperson said they are in discussions with payers, including the key Medicare plans, to ensure access to the drug.

The company said they plan to launch Zunveyl first in the long-term market, which represents 36% of the overall Alzheimer’s disease market, followed by expansion to the neurology segment once payer reimbursement has been established.

Despite the introduction of monoclonal antibodies for Alzheimer's disease (AD) — such as Eli Lily’s Kisunla (donanemab-azbt) and Eisai's Aduhelm (aducanumab-avwa) — the Alpha Cognition spokesperson said there many unmet needs for patients.

"It is important to note that monoclonal antibodies are a different type of AD medicine," the spokesperson said. "They are disease modifying agents, and are indicated to slow the progression of the disease. They are not indicated for the symptoms of AD (memory, thinking skills, and eventually the ability to do simple tasks, like carry on a conversation.) Zunveyl addresses several critical unmet needs in the AD treatment landscape through its innovative approach that targets AD symptoms directly, designed to provide patients with significant benefits to cognitive and global function and the ability to perform daily living activities."

Elaine Peskind, M.D.

“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,” Elaine Peskind, M.D., the Friends of Alzheimer’s Research Professor of Psychiatry at the University of Washington School of Medicine, said in a news release.

The approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of Zunveyl compared with galantamine immediate-release tablets and galantamine extended-release capsules. The efficacy was established in three bioavailability studies in healthy adults. In these patients, GI adverse events were less than 2% and no insomnia was seen.

Separately, Zunveyl is also being developed in combination with memantine to treat moderate-to-severe Alzheimer’s dementia, and as an intranasal formulation for cognitive impairment with mild traumatic brain injury. Additionally, the company is conducting preclinical testing of a sublingual formulation for patients who have difficulty with oral drugs.