Melt Pharmaceuticals announced the dosing of the last patient in its pivotal phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT‑300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery.
The phase 3 clinical trial is a randomized, double-blind, three-arm study comparing, at a 4:1:1 ratio, MELT-300, sublingual midazolam and sublingual placebo, respectively, for procedural sedation. The study was conducted at 13 clinical sites and enrolled over 525 patients. Melt anticipates a topline readout from the study before the end of 2024.
MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one tablet that is administered sublingually using Catalent’s proprietary Zydis delivery technology to dissolve and absorb the active ingredients across the sublingual mucosa rapidly — offering needle-free sedation.
Tennessee-based Melt also shared that it had reached an agreement with the U.S. FDA on a Special Protocol Assessment (SPA) for the MELT-300 phase 3 study, with the agency agreeing that the study addresses the objectives necessary to support a future regulatory submission.
Back in April, Melt, which specializes in developing novel approaches for procedural sedation, announced the completion of its Series B Preferred Stock financing of approximately $24 million from new and existing investors. The capital raised was earmarked to support the further development of MELT-300.