Melt Pharmaceuticals announced the dosing of its last patient in the Phase 3 study evaluating safety and efficacy for MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. MELT-300 combines 3 mg of midazolam with 50 mg of ketamine in one tablet that is administered sublingually using Catalent's proprietary Zydis delivery technology to dissolve and absorb the active ingredients into the sublingual mucosa rapidly, the company said in a press release.  

The Phase 3 clinical trial is a randomized, double-blind, three-arm study comparing MELT-300 with sublingual placebo; more than 525 patients are enrolled at 13 clinical sites. The company expects topline results before the end of this year.

Melt Pharmaceuticals also announced an agreement with the FDA on a Special Protocol Assessment (“SPA”) for the Melt-300 Phase 3 study. This agreement establishes a binding agreement on key elements to support a future marketing application. The FDA agreed the study would “adequately address the objectives necessary to support a regulatory submission.” And based on its review of results from a recent cardiac safety study evaluating the potential risk for a serious drug-induced irregular heart rhythm, the FDA agreed that MELT-300 did not alter normal heart rhythm. A final decision regarding marketing approval will be based on the FDA’s review of the full MELT-300 submission package.