In This Article:
MELT-300 Demonstrates Statistically Superior Compared to Both Sublingual Midazolam (P=0.009) and Placebo (P<0.001) for Providing Successful Procedural Sedation
Proportion of Patients Requiring Rescue Sedation Was Nearly Two-Fold Higher for Sublingual Midazolam Compared with MELT-300 (P=0.003)
MELT-300 Had a Favorable Safety Profile That Was Generally Comparable to Placebo
NASHVILLE, Tenn., November 20, 2024--(BUSINESS WIRE)--Melt Pharmaceuticals, Inc. ("Melt"), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced positive topline results of its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT‑300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. Based on a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration ("FDA") earlier this year, this study design and these positive results support the necessary objectives required for a regulatory submission.
MELT-300 uniquely combines a fixed dose of midazolam (3mg) and ketamine (50mg) in one tablet that is administered sublingually using Catalent’s proprietary Zydis® delivery technology which dissolves in as little as 3 seconds allowing absorption of the active ingredients across the sublingual mucosa.
The MELT-300 Phase 3 clinical trial was a randomized, double-blind, three-arm study comparing, at a 4:1:1 ratio, MELT-300, sublingual midazolam, and sublingual placebo, respectively, for procedural sedation in patients undergoing cataract surgery. The study was conducted at 13 clinical sites in the United States and enrolled over 530 patients.
In commenting on the topline results, Dr. Larry Dillaha, Chief Executive Officer of Melt, said, "We are extremely excited with this robust topline data from our pivotal Phase 3 study. These overwhelmingly positive results support our belief that MELT-300, if approved by the FDA, would be a safe and effective non-IV, non-opioid alternative to current IV-based cataract surgery sedation protocols, which generally involve the administration of opioids. With the number of cataract surgeries performed each year in the U.S. expected to exceed 5 million in the coming years, we believe offering patients and physicians the ability to achieve an adequate sedation level without the need to start an IV or administer opioids is a very attractive proposition."
MELT-300 co-inventor, Melt Pharmaceuticals board member, and board-certified ophthalmologist John Berdahl, M.D., commented, "A proprietary compounded combination of midazolam and ketamine, which was the inspiration for the development of the MELT-300 product candidate, has been used by hundreds of ophthalmologists, including myself – in hundreds of thousands of cataract surgeries. I am thrilled at the prospect of the FDA approving MELT-300, which I believe would greatly enhance the confidence of healthcare professionals in considering the adoption of this groundbreaking sedation method."