Pharma Focus Europe

Melt Pharmaceuticals Announces Dosing of Last Patient in Phase 2 Pivotal Efficacy and Safety Study for MELT-300

Monday, October 31, 2022

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company dedicated to developing innovative solutions for procedural sedation and analgesia, has announced the completion of patient dosing in its Phase 2 pivotal efficacy and safety study for its primary product candidate, MELT-300. MELT-300 is a patented sublingual formulation designed for needle- and opioid-free procedural sedation and analgesia during cataract surgery. The company expects to release top-line results from the study before the end of the year.

MELT-300 is a dissolvable tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg). It utilizes Catalent's proprietary fast-dissolving Zydis® delivery technology, allowing for rapid dissolution and absorption across the sublingual mucosa.

The Phase 2 study employed a factorial-designed, randomized, double-blind, placebo-controlled, parallel-cohort approach. It aimed to evaluate the efficacy and safety of MELT-300, as well as the individual contributions of midazolam and ketamine components to sedation and intraoperative ocular analgesia in patients undergoing cataract extraction with lens replacement (CELR). The trial compared MELT-300 against placebo alone, sublingually delivered midazolam alone, and sublingually delivered ketamine alone. The primary efficacy endpoints were appropriate sedation during cataract surgery and effective management of intraoperative pain. The study involved over 330 subjects across nine sites.

Larry Dillaha, M.D., CEO of Melt Pharmaceuticals, expressed enthusiasm about the completion of patient dosing in the MELT-300 Phase 2 study. He stated that the company anticipates reporting top-line results by the end of 2022, representing a significant advancement in their mission to offer needle- and opioid-free procedural sedation and analgesia. Dr. Dillaha expressed gratitude to the investigators and patients involved in the pivotal efficacy and safety study, emphasizing that this study represents a serious effort to improve anesthesia care for the approximately 5 million Americans who undergo cataract surgery each year. If successful, the company plans to discuss the study results and next steps in the continued development of MELT-300 with the U.S. Food and Drug Administration (FDA), aiming to provide a needle- and opioid-free option for sedation and analgesia.

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