Research & Development
Melt Pharmaceuticals Posts MELT-210 Top-Line Results of Phase 1 Pharmacokinetics Study for Procedural Sedation
4 May 2022 - - US-based clinical-stage pharmaceutical company Melt Pharmaceuticals, Inc has posted top-line results of its phase 1 pharmacokinetics 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 company said.

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.

MELT-210 is administered in a rapidly dissolving, sublingual tablet developed in partnership with Catalent, using its proprietary Zydis orally disintegrating tablet 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.

Melt Pharmaceuticals is a clinical-stage pharmaceutical company focused on the development and commercialization of patented non-intravenous and non-opioid sedation and analgesia medicines for medical procedures in outpatient and in-office settings.

Melt's core technology is a series of non-opioid sedation drug formulations that may replace or supplement current sedation and/or analgesia modalities for more than 100 m medical procedures in the United States.

Melt Pharmaceuticals, Inc. was carved out of Harrow Health, Inc. (NASDAQ: HROW) in 2019.


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