Melt Pharma Begins Dosing in Phase 3 Trial of MELT-300 for Needle- and Opioid-Free Cataract Surgery Sedation

NASHVILLE, Tenn. -- Melt Pharmaceuticals, a clinical-stage company specializing in novel sedation methods, has commenced its Phase 3 clinical trial for MELT-300, the company's leading product candidate. MELT-300 is a non-intravenous, non-opioid tablet containing fixed doses of midazolam (3mg) and ketamine (50mg), designed to dissolve sublingually using Catalent Inc.’s Zydis® technology for swift absorption through the sublingual mucosa.

The Phase 3 trial involves a randomized, double-blind study across 14 clinical sites, enrolling 528 patients undergoing cataract surgery. The study employs a 4:1:1 ratio to compare MELT-300, sublingual midazolam, and a sublingual placebo, aiming to assess the safety and efficacy of MELT-300 for procedural sedation. The topline results are expected by the fourth quarter of 2024.

Previously, Melt Pharmaceuticals reported positive outcomes from its Phase 2 clinical trial, which also focused on cataract surgery patients. This trial compared MELT-300 against a sublingual placebo, sublingual midazolam, and sublingual ketamine in over 300 patients. Results indicated that MELT-300 outperformed all comparator groups in procedural sedation: sublingual placebo (P <0.0001), sublingual midazolam (P=0.0129), and sublingual ketamine (P=0.0096).

Dr. Larry Dillaha, CEO of Melt Pharmaceuticals, expressed enthusiasm about the commencement of the Phase 3 program, emphasizing the unmet needs in outpatient procedural sedation over the past two decades. "IV-administered medications have been the standard, contributing to increased opioid usage," said Dr. Dillaha. "We believe MELT-300 could transform procedural sedation, enhancing patient comfort by eliminating needle sticks and reducing opioid exposure."

Dr. Dillaha noted the initial target for MELT-300 is cataract surgeries, which are expected to exceed five million annually in the U.S. alone. He also highlighted the broader potential for MELT-300, suggesting that with further development and regulatory approval, it could be applicable to over 100 million procedures annually in fields like dermatology, plastic surgery, dental work, gastrointestinal procedures, and emergency care.

About Melt Pharmaceuticals

Melt Pharmaceuticals, Inc. focuses on the development of proprietary non-opioid, non-IV sedation, and pain management therapies for medical procedures in various settings, including hospitals, outpatient clinics, and offices. The company plans to pursue FDA approval through the 505(b)(2) regulatory pathway for its patented small-molecule product candidates. Melt's core intellectual property is protected by multiple patents across North America, Europe, Asia, and the Middle East. Formerly a subsidiary of Harrow, Inc. (Nasdaq: HROW), Melt Pharmaceuticals became an independent entity in 2019.

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