Melt Pharmaceuticals Announces Positive Phase 3 Trial Results for MELT-300 Sedation Solution
Melt Pharmaceuticals announced positive topline results from its pivotal phase 3 trial of MELT-300. This novel, non-intravenous, non-opioid tablet is designed to provide effective sedation during cataract surgery.
The phase 3 study, conducted under a Special Protocol Assessment (SPA) agreement with the FDA, demonstrated that MELT-300 achieved its safety and efficacy goals, supporting the criteria required for regulatory submission. The product combines midazolam (3mg) and ketamine (50mg) in a single sublingual tablet that dissolves in as little as 3 seconds using Catalent’s proprietary Zydis delivery technology.
The trial enrolled over 530 patients at 13 US clinical sites in a randomized, double-blind, three-arm design. MELT-300 was compared against sublingual midazolam and placebo at a 4:1:1 ratio. The results indicated that the combination of midazolam and ketamine provided superior sedation compared to midazolam alone.
“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," Larry Dillaha, MD, Melt Pharmaceuticals’ Chief Executive Officer, said in a company news release. "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.”
“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," said John Berdahl, MD, MELT-300 co-inventor. "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.”
In addition to facilitating a regulatory submission, Melt says the positive phase 3 data bolster the company's intellectual property portfolio and opens opportunities for MELT-300’s use in other medical specialties, including dermatology, dentistry, gastroenterology, and emergency care.
Melt Pharmaceuticals now plans to move forward with an FDA submission, with the aim of making MELT-300 available to healthcare providers and their patients in the near future.