Melt Announces Completion of Patient Dosing in Phase 3 Study of MELT-300 for Procedural Sedation

Melt Pharmaceuticals announced the completion of patient dosing in its pivotal phase 3 clinical trial. This study evaluates the safety and efficacy of MELT-300, the company's lead product candidate, for providing non-intravenous, non-opioid sedation during cataract surgery.

MELT-300 is a sublingual tablet that delivers fixed doses of midazolam (3mg) and ketamine (50mg) through Catalent’s proprietary Zydis technology. The tablet dissolves under the tongue, allowing the active ingredients to be absorbed rapidly through the mucosal membrane. This clinical trial, conducted across 13 sites with over 525 patients, compares MELT-300 to sublingual midazolam and a placebo in a randomized, double-blind study with a 4:1:1 ratio. Results from the trial are expected by the end of 2024.

Additionally, Melt announced an agreement with the FDA on a Special Protocol Assessment (SPA) for the phase 3 study, confirming that the trial’s design meets the regulatory requirements needed for future approval. The FDA also reviewed a separate cardiac safety study of MELT-300, which showed no impact on normal heart rhythm, reducing concerns about potential drug-induced cardiac issues.

Previously, the company shared positive results from its phase 2 trial in over 300 cataract patients, where MELT-300 demonstrated superior sedation compared to sublingual placebo, midazolam, and ketamine, with statistically significant outcomes (P<0.0001, P=0.0129, and P=0.0096, respectively).

“Completing enrollment in our phase 3 study and securing FDA agreement on our SPA are critical milestones in our effort to deliver needle- and opioid-free sedation," Larry Dillaha, MD, CEO of Melt Pharmaceuticals, said in a company news release. "We are grateful to the investigators and patients who made this possible and eagerly await the trial’s findings."

Dr. Dillaha also highlighted the broader potential for MELT-300 beyond cataract surgery. “This is the first significant advancement in procedural sedation for cataract patients, of whom over 5 million undergo the surgery annually in the US. Success in this trial could lead to further development for use in over 100 million procedures across various fields, including dermatology, dentistry, and emergency care."