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Melt Pharmaceuticals Announces MELT-210 Top-Line Results of Phase 1 Pharmacokinetics (PK) Study for Procedural Sedation

Bioavailability of MELT-210 Compares Favorably to Reference Drug

NASHVILLE, Tenn.– Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation and analgesia, today announced top-line results of its phase 1 pharmacokinetics (PK) study of MELT-210. MELT-210 is a fixed dose of 3 mg of midazolam formulated in a proprietary rapidly dissolving sublingual tablet technology for procedural sedation.

The study was conducted in 23 patients and compared 3 mg and 6 mg MELT-210 sublingual midazolam tablets against an IV-administered comparator of midazolam. The top-line data demonstrated that concentration comparisons between MELT-210 and the reference drug met the goals of the study.

“We are pleased with the data that we are seeing from our PK study of MELT-210,” said Larry Dillaha, M.D., CEO of Melt Pharmaceuticals. “We view this as another important milestone in our goal to provide patients and their doctors with an IV-free option for procedural sedation. Our next step is meeting with the U.S. Food and Drug Administration (FDA) to discuss the results from this study and our continued clinical development of MELT-210.”

MELT-210 is administered in a rapidly dissolving, sublingual tablet developed in partnership with Catalent, using its proprietary Zydis® orally disintegrating tablet (ODT) technology to create a tablet that dissolves quickly when placed under the tongue. This technology has been used in over 35 NDA-approved products, spanning almost three decades. Because of the uniqueness of Catalent’s technology, no therapeutically equivalent product has been approved by the FDA for any of the previously NDA-approved products using Zydis®.