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FDA has accepted MELT-100 IND; Phase 1 study enrollment to start immediately

Boston – July 28, 2020 – Melt Pharmaceuticals, Inc., a clinical stage pharmaceutical  company developing first-in-class medicines for sedation and analgesia, announced today that following the recent acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s Investigational New Drug (IND) filing for MELT-100, a patented sublingual, non-opioid pain and sedation medication, the company intends to immediately commence its Phase 1 clinical program, with results expected in the fourth quarter of this year.

MELT-100 is a patented combination of midazolam and ketamine in a rapidly dissolving, sublingual tablet to provide sedation and analgesia for patients undergoing cataract surgery. This needle-free and opioid-free approach seeks to replace the current practice of IV-delivered sedation medication for patients.  MELT-100 is being developed in partnership with Catalent using its proprietary Zydis® orally disintegrating tablet (ODT) technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water.

The Phase 1 study is a pharmacokinetics (PK) study with the objective to characterize the single-dose PK parameter of midazolam and ketamine after administration of MELT-100 and compare it to IV-administered formulations of both midazolam and ketamine.  Data from this study is expected to be available in the fourth quarter of 2020.

Greg Madison, CEO of Melt Pharmaceuticals, commented, “I am pleased with this important milestone for the company and excited to begin our Phase 1 studies.   It is time that we reinvent the way we sedate patients for short duration procedures, such as cataract surgery, and we believe that a needle-free or IV-free approach could provide significant benefits to patients and clinicians alike, while simultaneously reducing reliance on opioids.  In addition to cataract surgery, we estimate there are up to 100 million additional procedures where MELT-100 could be beneficial.  Our goal is to make needles pointless.”

About Melt Pharmaceuticals

Melt Pharmaceuticals, Inc., is a pharmaceutical company focused on the development and commercialization of patented non-intravenous and non-opioid sedation and analgesia medicines for short duration medical procedures in outpatient and in-office settings.  Melt intends to seek regulatory approval through the U.S. Food and Drug Administration’s 505(b)(2) regulatory pathway for these proprietary technologies.  Melt’s core technology is a series of combination non-opioid sedation drug formulations that may replace or supplement current sedation modalities for more than 100 million medical procedures in the United States.  Melt Pharmaceuticals, Inc. was spun out of Harrow Health (NASDAQ: HROW) in 2019.

To learn more about Melt, please visit their website: https://www.meltpharma.com/.

Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Melt Pharmaceuticals undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Zydis® and all other trademarks, service marks and trade names included or referenced in this press release, are the property of their respective owners.

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Investor Contact for Melt:

Greg Madison
gmadison@meltpharma.com