Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, announced positive topline results from its pivotal Phase 3 study evaluating MELT-300. This product candidate is a non-IV, non-opioid tablet for procedural sedation during cataract surgery. The study's design and positive results support the necessary objectives for a regulatory submission to the U.S. Food and Drug Administration (FDA).
MELT-300 combines a fixed dose of midazolam (3mg) and ketamine (50mg) in a sublingual tablet, designed for rapid absorption. The Phase 3 trial was a randomized, double-blind, three-arm study conducted at 13 U.S. clinical sites, enrolling over 530 patients. The data demonstrated the superiority of the midazolam and ketamine combination compared to midazolam alone.
Dr. Larry Dillaha, CEO of Melt, stated that these robust results support the belief that MELT-300, if approved, would be a safe and effective alternative to current IV-based sedation protocols. Harrow, Inc. holds an equity interest in Melt Pharmaceuticals, making this development a significant positive for its investment portfolio. The market for cataract surgeries in the U.S. is expected to exceed 5 million annually.
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