Melt Pharmaceuticals Announces Positive Phase 3 Results for MELT-300 in Cataract Surgery Sedation

Melt Pharmaceuticals, Inc., a clinical-stage company based in Nashville, Tennessee, has released promising results from its pivotal Phase 3 study of MELT-300. The company's new product, MELT-300, is a non-intravenous, non-opioid tablet designed for procedural sedation during cataract surgery. These results, achieved through a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), are anticipated to support regulatory submission objectives.

MELT-300 is a unique combination of midazolam (3mg) and ketamine (50mg) in a single tablet. This tablet, administered sublingually, employs Catalent's Zydis® delivery technology, which allows the tablet to dissolve in as little as three seconds, enabling rapid absorption of the medication through the sublingual mucosa.

The Phase 3 trial for MELT-300 was a randomized, double-blind study that included over 530 patients across 13 clinical sites in the United States. The study compared MELT-300 with sublingual midazolam and a sublingual placebo in a 4:1:1 ratio for procedural sedation in cataract surgery patients.

Dr. Larry Dillaha, CEO of Melt Pharmaceuticals, expressed enthusiasm about the study's results, emphasizing the potential of MELT-300 as a safe and effective alternative to current IV-based sedation methods, which often involve opioids. He highlighted the significant number of cataract surgeries performed annually in the U.S., which is expected to exceed five million in the coming years. Dr. Dillaha believes that MELT-300 offers a compelling alternative by eliminating the need for IV administration and opioid use.

Dr. John Berdahl, a co-inventor of MELT-300 and a board-certified ophthalmologist, shared his excitement about the prospect of FDA approval for MELT-300. He noted that the combination of midazolam and ketamine, which inspired MELT-300, has been effectively used by many ophthalmologists, including himself, in numerous cataract surgeries. Dr. Berdahl believes that FDA approval would boost healthcare professionals' confidence in adopting this innovative sedation method.

Dr. George Magrath, a board-certified ophthalmologist and principal investigator of the MELT-300 Phase 3 study, commented on the study data showing the superiority of the midazolam and ketamine combination compared to midazolam alone. He expressed optimism about MELT-300 becoming a safe and effective alternative to current sedation methods for cataract surgery, enhancing the overall patient experience.

Dr. Dillaha further explained that the Phase 3 data not only support regulatory submission but also strengthen Melt Pharmaceuticals' patent portfolio. He sees this as a step towards elevating the standard of care for procedural sedation in cataract surgery and expanding MELT-300's potential use to over 100 million annual procedures across various medical specialties, including dermatology, plastic surgery, dentistry, gastroenterology, and emergency care.

Melt Pharmaceuticals expressed gratitude to the participants of the Phase 3 MELT-300 study, including ophthalmologists, optometrists, anesthesiologists, certified registered nurse anesthetists, staff, and patients at the 13 U.S. clinical sites.

Melt Pharmaceuticals, Inc., focuses on developing proprietary non-IV, non-opioid sedation and analgesia therapeutics for various medical procedures. The company aims to seek FDA approval through the 505(b)(2) regulatory pathway for its small-molecule product candidates. Melt Pharmaceuticals' core intellectual property is protected by multiple patents in North America, Europe, Asia, and the Middle East. The company was previously a subsidiary of Harrow, Inc. and became an independent entity in 2019.