Melt Pharmaceuticals has announced the completion of dosing the final patient in its pivotal Phase 3 clinical trial evaluating MELT-300, a novel sublingual tablet designed for procedural sedation during cataract surgery. This non-IV, non-opioid approach aims to provide a safer and more convenient alternative to traditional sedation methods.
The Phase 3 trial (NCT06383273) is a randomized, double-blind, three-arm study conducted across 13 clinical sites, enrolling over 525 patients. The trial compares MELT-300 to sublingual midazolam and sublingual placebo in a 4:1:1 ratio. Midazolam is included to confirm the benefit of adding ketamine to the combined drug product.
MELT-300: A Novel Sublingual Sedative
MELT-300 combines a fixed dose of 3mg midazolam and 50mg ketamine in a single tablet. Utilizing Catalent’s Zydis delivery technology, the tablet dissolves rapidly under the tongue, allowing for quick absorption of the active ingredients through the sublingual mucosa.
Efficacy and Safety Assessments
The study assesses efficacy at multiple time points: after study medication administration before surgery, intraoperatively, and postoperatively on Day 1. Key efficacy measures include assessments of sedation levels, the need for rescue medication for sedation or pain, and the ability to complete the surgery successfully.
Special Protocol Assessment (SPA) Agreement with FDA
Melt Pharmaceuticals has also secured a Special Protocol Assessment (SPA) agreement with the FDA for the MELT-300 Phase 3 study. This agreement establishes a binding framework on key elements necessary to support a future marketing application, potentially streamlining the regulatory review process.
Promising Phase 2 Results
Data from the Phase 2 clinical trial of MELT-300 demonstrated statistically significant superiority in procedural sedation compared to all individual comparator arms: sublingual placebo (P < 0.0001), sublingual midazolam (P = 0.0129), and sublingual ketamine (P = 0.0096).
Implications for Cataract Surgery and Beyond
Dr. Larry Dillaha, CEO of Melt, stated that successful completion of the Phase 3 study and the FDA's SPA agreement are key milestones. He also noted the potential for MELT-300 to be utilized for procedural sedation in over 100 million annual procedures in areas such as dermatology, plastics, dental, gastrointestinal, and emergency rooms.
Topline results from the Phase 3 trial are anticipated before the end of 2024.
