Melt Pharmaceuticals, Inc., a clinical-stage company focused on innovative procedural sedation solutions, has announced the dosing of the last patient in its pivotal Phase 3 study of MELT-300, a non-IV, non-opioid tablet designed for procedural sedation during cataract surgery.
MELT-300 combines 3 mg of midazolam and 50 mg of ketamine in a single sublingual tablet, utilizing Catalent’s proprietary Zydis® delivery technology for rapid absorption through the sublingual mucosa. The Phase 3 trial is a randomized, double-blind study comparing MELT-300 with sublingual midazolam and a placebo across three arms, involving over 525 patients at 13 clinical sites. Topline results are expected by the end of 2024.
Additionally, Melt announced it has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), confirming that the study’s design will adequately support a regulatory submission. The FDA also indicated that MELT-300 does not impact normal heart rhythm, based on a recent cardiac safety study.
Previous Phase 2 trial results showed MELT-300’s superiority in procedural sedation over all comparator arms, including sublingual placebo (P<0.0001), midazolam (P=0.0129), and ketamine (P=0.0096).
Dr. Larry Dillaha, CEO of Melt, stated, “Completing enrollment and securing FDA agreement on our SPA are significant milestones for MELT-300. We thank the investigators and patients involved in this critical study and look forward to sharing our findings soon.”
Dr. Dillaha emphasized the potential impact of MELT-300, noting it could advance procedural sedation standards for the estimated 5 million cataract surgeries performed annually in the U.S., with broader applications in fields like dermatology, dentistry, and emergency care.
About Melt Pharmaceuticals
Melt Pharmaceuticals, Inc. is dedicated to developing non-IV, non-opioid sedation and analgesia therapies for medical procedures in various settings. The company aims to navigate the FDA’s 505(b)(2) regulatory pathway for its patented products. Melt holds multiple granted patents across North America, Europe, Asia, and the Middle East, and was established as a standalone entity in 2019 after being carved out from Harrow, Inc. (Nasdaq: HROW).
