Melt Pharmaceuticals' MELT-300: A Game-Changer in Opioid-Free Procedural Sedation

Melt Pharmaceuticals, Inc. has announced positive topline efficacy results from its Phase 3 study of MELT-300, its lead product candidate for opioid-free, sublingual procedural sedation in patients undergoing cataract surgery. The results demonstrate MELT-300's potential to revolutionize the market for procedural sedation, addressing unmet needs and offering a non-IV, non-opioid alternative.

MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in a rapidly dissolving tablet, administered sublingually using Catalent's proprietary Zydis delivery technology. The Phase 3 study, a randomized, double-blind, three-arm trial comparing MELT-300, sublingual midazolam, and sublingual placebo at a 4:1:1 ratio, enrolled over 525 patients across 13 clinical sites.

The primary efficacy endpoints were appropriate cataract surgery sedation using a validated sedation scale (Ramsay Sedation Scale) and the management of intraoperative pain during the cataract surgery. MELT-300 demonstrated statistically significant outcomes compared to placebo, midazolam, and ketamine, with P-values of <0.0001, 0.0129, and 0.0096, respectively.



The combination of midazolam and ketamine in MELT-300 offers a synergistic effect, enhancing its sedation efficacy. Midazolam provides anxiolytic and amnestic effects, while ketamine offers analgesic and sedative properties. The sublingual administration using Catalent's Zydis technology allows for rapid absorption, ensuring quick onset of action.

The non-IV, non-opioid nature of MELT-300 addresses several unmet needs in the market for procedural sedation during cataract surgery. It eliminates the need for intravenous (IV) lines, reducing patient discomfort and anxiety, and minimizing the risk of IV-related infections. Its opioid-free formulation helps combat the opioid epidemic, as it avoids the potential for opioid dependence and misuse. Additionally, MELT-300's sublingual administration allows for rapid absorption, providing quick and effective sedation, and its convenience may improve patient satisfaction and workflow efficiency in healthcare settings.

The positive Phase 3 results for MELT-300 open doors to label expansion and use in other medical procedures. With over 100 million annual procedures in areas like dermatology, plastics, dental, gastrointestinal, and emergency rooms, MELT-300's opioid-free, sublingual sedation could significantly impact these markets. Success in the MELT-300 Phase 3 study could lead to further development and label expansion, potentially allowing MELT-300 to be utilized in these procedures, reducing the need for IV-administered sedation and opioids.

In conclusion, Melt Pharmaceuticals' positive Phase 3 results for MELT-300 indicate a promising future for opioid-free, sublingual procedural sedation in patients undergoing cataract surgery and potentially other medical procedures. As the market for procedural sedation continues to evolve, MELT-300's unique combination of midazolam and ketamine, along with its non-IV, non-opioid formulation, positions it as a strong contender in the market.