Melt Pharmaceuticals Reports First Patient Dosed In Phase 3 Program Of Its MELT-300, For Needle- And Opioid-Free Sedation In Patients Undergoing Cataract Surgery; Topline Readout Expected In Q4 2024
Melt Pharmaceuticals, Inc. ("Melt"), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced that the first patient has been dosed in its Phase 3 program evaluating the safety and efficacy of its lead product candidate, MELT-300, a non‑IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg). MELT-300 is administered sublingually using Catalent Inc.'s proprietary fast‑dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the sublingual mucosa.
The MELT-300 Phase 3 clinical trial is a randomized, double-blind, three-arm study comparing – at a 4:1:1 ratio – MELT-300, sublingual midazolam, and sublingual placebo for procedural sedation in 528 patients undergoing cataract surgery at 14 participating clinical sites. The topline readout is expected in the fourth quarter of 2024.