Positive Phase 3 Results for MELT-300 Sedation

Melt Pharmaceuticals has reported promising topline results from the pivotal Phase 3 trial of MELT-300, a novel, non-intravenous, non-opioid sedation tablet developed for use during cataract surgeries. The study, conducted under an FDA-approved Special Protocol Assessment (SPA) agreement, demonstrated that MELT-300 meets safety and efficacy criteria required for regulatory submission.

What is MELT-300?

MELT-300 is an innovative sublingual tablet combining:

       • Midazolam (3 mg)

       • Ketamine (50 mg)

The tablet dissolves in just three seconds, thanks to Catalent’s proprietary Zydis delivery technology, offering an effective alternative to IV-based sedation protocols.

Phase 3 Trial Highlights

The trial enrolled over 530 patients across 13 U.S. clinical sites and utilized a randomized, double-blind, three-arm design. Key comparisons included:

       • MELT-300 vs. sublingual midazolam

       • MELT-300 vs. placebo

       • Patients were randomized in a 4:1:1 ratio.

Key Results

       • MELT-300 achieved superior sedation compared to midazolam alone.

       • No serious safety concerns were reported.

Dr. Larry Dillaha, CEO of Melt Pharmaceuticals, commented:

“These overwhelmingly positive results support our belief that MELT-300, if approved by the FDA, would be a safe and effective non-IV, non-opioid alternative to current IV-based cataract surgery sedation protocols.”

Transforming Cataract Surgery Sedation

With over 5 million cataract surgeries projected annually in the U.S. in the coming years, MELT-300 offers a streamlined alternative to traditional IV sedation:

       • Eliminates the need for IV setups.

       • Avoids the use of opioids.

Dr. John Berdahl, co-inventor of MELT-300, added:

“A proprietary compounded combination of midazolam and ketamine has been used successfully in hundreds of thousands of cataract surgeries. FDA approval of MELT-300 would greatly enhance confidence in this groundbreaking sedation method.”

Expanding Opportunities Beyond Ophthalmology

The success of the Phase 3 trial not only supports regulatory submission but also strengthens Melt’s intellectual property portfolio. Potential future applications for MELT-300 include:

       • Dermatology

       • Dentistry

       • Gastroenterology

       • Emergency care

Next Steps

Melt Pharmaceuticals plans to submit MELT-300 for FDA approval, aiming to make this innovative sedation solution available to healthcare providers and their patients in the near future.

This milestone represents a significant step toward revolutionizing sedation practices across multiple medical specialties.