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

Rhea-AI Summary

Melt Pharmaceuticals announced favorable top-line results from its phase 1 PK study of MELT-210, a 3 mg sublingual midazolam tablet. The study involving 23 patients compared MELT-210 with IV midazolam and achieved concentration goals. CEO Larry Dillaha expressed optimism about the results, viewing it as a milestone for an IV-free sedation option. The next step includes discussions with the FDA regarding further clinical development. MELT-210 utilizes Catalent's proprietary Zydis® technology, with no FDA-approved equivalent products.

Positive

• Top-line results of MELT-210 PK study met concentration goals.
• Potential for an IV-free option for procedural sedation.
• Next steps include meeting with FDA to discuss study results.

Negative

• None.

Bioavailability of MELT-210 Compares Favorably to Reference Drug

NASHVILLE, Tenn.--(BUSINESS WIRE)-- 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^®.

About Melt Pharmaceuticals

Melt Pharmaceuticals, Inc. 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 million medical procedures in the United States. Melt Pharmaceuticals, Inc. was carved out of Harrow Health, Inc. (Nasdaq: HROW) in 2019. To learn more about Melt, please visit their website, www.meltpharma.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220503006359/en/

Investor Contact:

Larry Dillaha, M.D.

Chief Executive Officer

ldillaha@meltpharma.com

Source: Melt Pharmaceuticals, Inc.

FAQ

What were the results of the phase 1 study for MELT-210?

The phase 1 PK study of MELT-210 met its concentration goals when compared to IV-administered midazolam.

What is MELT-210 and how is it administered?

MELT-210 is a 3 mg sublingual midazolam tablet formulated for procedural sedation, utilizing Catalent's Zydis® technology.

What are the next steps for Melt Pharmaceuticals after the PK study results?

The company plans to meet with the FDA to discuss the results and the continued clinical development of MELT-210.

How many patients participated in the MELT-210 study?

The study involved 23 patients.

What is the significance of Catalent's Zydis® technology in MELT-210?

Zydis® technology enables the rapid dissolution of the tablet under the tongue, enhancing patient convenience and effectiveness.