Melt Pharmaceuticals announced positive topline results from its Phase 3 clinical trial evaluating MELT-300, a novel sublingual tablet for procedural sedation in patients undergoing cataract surgery. The study, conducted across 13 U.S. clinical sites with over 530 patients, demonstrated statistically significant superiority of MELT-300 over both sublingual midazolam and placebo.
The trial's success, based on a Special Protocol Assessment agreement with the FDA, supports a regulatory submission for MELT-300. This innovative tablet combines a fixed dose of midazolam (3mg) and ketamine (50mg) utilizing Catalent’s Zydis® delivery technology, allowing it to dissolve in approximately 3 seconds for rapid absorption.
Efficacy and Safety
The Phase 3 trial was a randomized, double-blind, three-arm study comparing MELT-300, sublingual midazolam, and sublingual placebo in a 4:1:1 ratio. Results indicated that patients receiving midazolam alone required nearly twice the rescue sedation compared to those receiving MELT-300 (P=0.003). Furthermore, MELT-300 exhibited a favorable safety profile comparable to placebo.
Dr. George Magrath, a principal investigator in the study, highlighted the significance of the findings: "These Phase 3 data show the superiority of the combination of midazolam and ketamine compared with midazolam alone. If approved, I believe MELT-300 will be a safe and effective alternative to current sedation methods used for cataract surgery."
Market Opportunity and Future Expansion
With over 5 million cataract surgeries performed annually in the U.S., MELT-300 presents a compelling alternative to current IV-based, often opioid-dependent, sedation protocols. Melt Pharmaceuticals aims to expand the potential use of MELT-300 to over 100 million annual procedures across various medical specialties, including dermatology, plastic surgery, dentistry, gastroenterology, and emergency care.
Dr. Larry Dillaha, CEO of Melt Pharmaceuticals, expressed enthusiasm about the results: "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."
The company intends to pursue regulatory approval via the FDA’s 505(b)(2) pathway, leveraging its robust patent portfolio to protect its intellectual property. The successful Phase 3 data further strengthens Melt's position in the procedural sedation market.
