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Melt Pharmaceuticals’ MELT-300 (Midazolam 3mg and Ketamine 50mg Sublingual Tablet) Achieves Primary Sedation Endpoint in Phase 2 Pivotal Efficacy and Safety Study
MELT-300 Statistically Superior for Procedural Sedation Compared to All Comparator Treatment Arms, Including Midazolam 3mg (P=0.0129) and Ketamine 50mg
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[{"type":"text","content":"\nMELT-300 Statistically Superior for Procedural Sedation Compared to All Comparator Treatment Arms, Including Midazolam 3mg (P=0.0129) and Ketamine 50mg (P=0.0096)\n\nMELT-300 Treatment Arm 50% Less Likely to Require Rescue Sedation Compared to Midazolam (P=0.0198)\n\nMELT-300 Treatment Arm 66% Less Likely to Require Rescue Sedation Pre-Operatively Compared to the Midazolam Treatment Arm\n\nMELT-300 Had a Favorable Safety Profile That Was Generally Comparable to Placebo\n\n NASHVILLE, Tenn.--(BUSINESS WIRE)--\nMelt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced top-line results of its Phase 2 pivotal efficacy and safety study for its lead product candidate, MELT-300, a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery. Based on the outcome of the MELT-300 data, the company intends to request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the results of this study and the continued clinical development of MELT-300.\n\nMELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one rapidly dissolving tablet (RDT) that is administered sublingually for procedural sedation during cataract surgery. MELT‑300 utilizes Catalent Inc.’s proprietary fast-dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the very thin sublingual mucosa.\n\nThe factorial-designed, randomized, double-blind, placebo-controlled, parallel-cohort Phase 2 study was designed to evaluate the efficacy and safety of MELT-300 and the contribution of midazolam and ketamine components to sedation and intraoperative ocular analgesia in subjects undergoing cataract surgery. The trial compared MELT-300 against (i) placebo alone, (ii) sublingually delivered midazolam alone, and (iii) sublingually delivered ketamine alone, with two independent primary efficacy endpoints: (a) appropriate cataract surgery sedation using a validated sedation scale (Ramsay Sedation Scale), or (b) the management of intraoperative pain during the cataract surgery. The study was conducted at nine sites and enrolled over 300 subjects.\n\n“We are extremely pleased with the robust sedation efficacy from our pivotal Phase 2 study of MELT-300,” said Larry Dillaha, M.D., CEO of Melt Pharmaceut...