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ZUNVEYL (benzgalantamine) is a new prodrug for Alzheimer's dementia, showing comparable absorption to existing galantamine ER but with a potentially safer side effect profile. This study confirms its tolerability and establishes a link to the established drug.

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Area of Science:

  • Pharmacology and Drug Development
  • Neuroscience and Neurology
  • Clinical Pharmacy and Therapeutics

Background:

  • ZUNVEYL (benzgalantamine) is a novel, pharmacologically inactive prodrug of galantamine, approved in 2024 for mild to moderate Alzheimer's dementia.
  • It utilizes the 505(b)(2) pathway, referencing existing FDA findings for Razadyne® (galantamine hydrobromide).
  • ZUNVEYL's delayed-release formulation aims to reduce gastrointestinal side effects common with acetylcholinesterase inhibitors, potentially improving patient compliance.

Purpose of the Study:

  • To assess the relative bioavailability of ZUNVEYL delayed-release (DR) tablets compared to galantamine hydrobromide extended-release (ER) capsules.
  • To evaluate the pharmacokinetic profile of ZUNVEYL under steady-state conditions.
  • To establish a scientific bridge between ZUNVEYL and its listed drug, galantamine hydrobromide ER.

Main Methods:

  • An open-label, randomized, comparative study involving 40 healthy adult subjects.
  • Subjects received multiple doses of ZUNVEYL DR tablets (5 mg BID for 7 days) and galantamine hydrobromide ER capsules (8 mg QD for 7 days) in a two-period crossover design.
  • Pharmacokinetic parameters were analyzed from plasma samples to determine galantamine levels.

Main Results:

  • Galantamine derived from ZUNVEYL represented less than 1% of total circulating drug, indicating a favorable safety profile.
  • Steady-state pharmacokinetic analysis showed comparable extent of absorption (AUC[0-24]ss) between ZUNVEYL and galantamine hydrobromide ER.
  • A slightly higher Cmaxss was observed for ZUNVEYL compared to the listed drug.

Conclusions:

  • ZUNVEYL was well-tolerated with no serious adverse events reported.
  • The study successfully established a scientific bridge to galantamine hydrobromide ER, supporting ZUNVEYL's efficacy.
  • The safety of ZUNVEYL's higher Cmax is supported by comparison with immediate-release galantamine formulations, suggesting a potentially improved gastrointestinal safety profile.