First patient dosed in Phase 3 clinical trial of MELT-300, procedural sedative for patients undergoing cataract surgery


MELT-300 is a non IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg).

(Image Credit: AdobeStock/Konstantin Maslak)

(Image Credit: AdobeStock/Konstantin Maslak)

Melt Pharmaceuticals announced the first patient has been dosed in its Phase 3 trial (NCT06383273) evaluating the safety and efficacy of MELT-300, a non‑IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg) for the procedural sedation of patients undergoing cataract surgery.

The company stated in a press release that MELT-300 is its lead product candidate and it is administered sublingually using “Catalent Inc’s proprietary fast‑dissolving Zydis delivery technology to rapidly dissolve the tablet for absorption across the sublingual mucosa.”1

The MELT-300 Phase 3 trial is a randomized, double-blind, three-arm study. It is comparing MELT-300, sublingual midazolam, and sublingual placebo at a 4:1:1 ratio. The company stated that 528 patients are enrolled across 14 clinical sites.1,2

Efficacy assessments during trial will be performed after medication administration before surgery, intraoperatively, and postoperative on Day 1. Assessments will include assessments of sedation, need for rescue medication for sedation, need for rescue medication for pain, and the ability to complete the surgery.2

Results from the Phase 2 clinical trial of MELT-300 showed MELT-300 was statistically superior for procedural sedation compared to all individual comparator arms: sublingual placebo (P <0.0001), sublingual midazolam (P=0.0129) and sublingual ketamine (P=0.0096).1

Larry Dillaha, MD, CEO of Melt, commented on the trial in a press release from the company.

“We believe that MELT-300 could revolutionize procedural sedation while enhancing the patient’s experience in all sites of care by offering greater comfort without a needle stick and by reducing exposure to opioids,” said Dillaha.

In the press release, Dillaha expressed interest in expanding the drug outside of cataract surgery use stating, “While we are initially targeting sedation during cataract surgery for MELT-300, estimated to be over 5 million annual procedures in the U.S. in the coming years, we believe with further development and label expansion, MELT-300 could be utilized in over 100 million annual procedures in areas such as dermatology, plastics, dental, gastrointestinal, and emergency rooms.”

Topline results are expected in the fourth quarter of 2024.

  1. Melt Pharmaceuticals Announces First Patient Dosed in Pivotal Phase 3 Program of Its Lead Product Candidate, MELT-300, for Needle- and Opioid-Free Sedation in Patients Undergoing Cataract Surgery. Press release; June 6, 2024. Accessed June 6, 2024.
  2. A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR). NCT06383273.
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