Melt Pharmaceuticals 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.”
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“Recent estimates are that more than 50% of the over four million annual cataract surgeries in the U.S. involve patients being exposed to opioids to manage pain,” said Maggie Jeffries, M.D., 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.”