Melt Pharmaceuticals reports positive Phase 3 topline efficacy results for MELT-300

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Melt Pharmaceuticals Inc announced positive topline results from 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.

According to the company, based on a Special Protocol Assessment agreement with the FDA earlier this year, the study design and these positive results support the necessary objectives required for a regulatory submission.

MELT-300 combines a fixed dose of midazolam (3 mg) and ketamine (50 mg) in one tablet, which is administered sublingually using Catalent’s proprietary Zydis delivery technology. This technology allows the tablet to dissolve in as little as 3 seconds, enabling absorption of the active ingredients across the sublingual mucosa.¹

The MELT-300 Phase 3 clinical trial was a randomized, double-blind, three-arm study designed to evaluate the efficacy of MELT-300 for procedural sedation in cataract surgery. Participants were assigned in a 4:1:1 ratio to receive either MELT-300, sublingual midazolam, or a sublingual placebo. Conducted at 13 clinical sites across the United States, the trial enrolled more than 530 patients.¹

Larry Dillaha, MD, CEO of Melt Pharmaceuticals, said the company was enthused by the topline data from its 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,” he said. “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, MD, said the candidate could offer a sedation alternative.

“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,” he said. “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.”

George Magrath, MD, a board-certified ophthalmologist and MELT-300 Phase 3 study principal investigator, pointed out that 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,” he said. “As an ophthalmologist, I am excited about the prospect of using MELT-300 to enhance the overall experience for my cataract surgery patients.”

Moreover, Dillaha noted that, in addition to supporting a regulatory submission, these MELT-300 Phase 3 data should further strengthen the company’s patent portfolio, both domestically and internationally.

“Further, with these data now confirming and complementing our robust Phase 2 efficacy and safety results, we believe we are well-positioned to elevate the procedural sedation standard of care for cataract surgery and, through lifecycle management, eventually expand the potential use of MELT-300 to over 100 million annual procedures in various medical specialties, including dermatology, plastic surgery, dentistry, gastroenterology, and emergency care,” he said.

Dillaha also extended his thanks to the Phase 3 MELT-300 study participants, whose involvement he said had been invaluable.

“This includes the ophthalmologists, optometrists, anesthesiologists, certified registered nurse anesthetists, staff, and patients at the 13 U.S. clinical sites,” he concluded.

Reference

1. Melt Pharmaceuticals Inc. Melt Pharmaceuticals Reports Positive Phase 3 Topline Efficacy Results for MELT-300, Its Lead Product Candidate for Opioid-Free, Sublingual Procedural Sedation in Patients Undergoing Cataract Surgery. Published November 20, 2024. Accessed November 20, 2024. https://www.businesswire.com/news/home/20241120082898/en/Melt-Pharmaceuticals-Reports-Positive-Phase-3-Topline-Efficacy-Results-for-MELT-300-Its-Lead-Product-Candidate-for-Opioid-Free-Sublingual-Procedural-Sedation-in-Patients-Undergoing-Cataract-Surgery