Melt Pharmaceuticals Completes Phase 1 Study for Sublingual, Non-Opioid Pain & Sedation Drug Candidate

Melt Pharmaceuticals, Inc. recently announced results from its MELT Phase 1 study, a comparative bioavailability study with the objective of characterizing the pharmacokinetic parameters of two dosage strengths of the patented MELT technology (midazolam 3 mg/ketamine 25 mg and midazolam 6 mg/ketamine 50 mg) in healthy volunteers and comparing it to IV-administered formulations of both midazolam and ketamine.

“We are pleased with the results of our Phase 1 MELT study, which marks another important milestone for the company,” said Greg Madison, CEO of Melt Pharmaceuticals. “The data established relative bioavailability and important pharmacokinetic parameters, including characterizing absorption rates following administration. Importantly, MELT was well tolerated by patients. With the Phase 1 study successfully meeting its objectives, in the coming months, we look forward to meeting with the FDA, finalizing our clinical protocol in patients undergoing cataract surgery, and initiating the Phase 2 clinical study in the third quarter of 2021.”

“Recent estimates are that more than 50% of the over 4 million annual cataract surgeries in the US involve patients being exposed to opioids to manage pain,” added Maggie Jeffries, MD, Board Certified Anesthesiologist, Eye Center of Texas, and Partner at Avanti Anesthesia. “If FDA approved, the potential for a pain-free, IV-free, opioid-free option for sedation and analgesia in cataract surgery is dramatic, providing benefits to patients and clinicians alike as we reduce our reliance on opioids.”

MELT 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 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.

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 short-duration medical procedures in outpatient and in-office settings. 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 US. Melt Pharmaceuticals, Inc. was carved out of Harrow Health, Inc. (NASDAQ: HROW) in 2019. For more information, visit