Melt Pharmaceuticals doses final patient in phase 3 trial of MELT-300

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Melt Pharmaceuticals has dosed the last patient in its pivotal phase 3 study (NCT06383273) evaluating MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery.

According to the company, MELT-300 combines fixed doses of 3mg midazolam and 50mg ketamine in a single tablet that is administered sublingually using Catalent’s proprietary Zydis delivery technology to dissolve and absorb the active ingredients across the sublingual mucosa rapidly.¹

The phase 3 clinical trial is a randomized, double-blind, three-arm study comparing MELT-300, sublingual midazolam, and sublingual placebo at a 4:1:1 ratio. It was conducted across 13 clinical sites with over 525 patients enrolled in the study. Midazolam is being used to confirm the benefit of inclusion of ketamine in the combined drug product.^1,2

Efficacy assessments are performed after study medication administration before surgery, intraoperatively, and postoperative on Day 1. Efficacy 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

Topline results from the trial are expected before the end of 2024.

Additionally, Melt also announced it has reached an agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the MELT-300 Phase 3 study, which establishes a binding agreement on key elements to support a future marketing application.¹

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).

References:

1. Melt Pharmaceuticals Announces Dosing of Last Patient in Pivotal Phase 3 Study of Its Lead Product Candidate, MELT-300, for Needle- and Opioid-Free Sedation in Patients Undergoing Cataract Surgery. Press Release; October 10, 2024. Accessed October 10, 2024. https://www.businesswire.com/news/home/20241010858192/en/Melt-Pharmaceuticals-Announces-Dosing-of-Last-Patient-in-Pivotal-Phase-3-Study-of-Its-Lead-Product-Candidate-MELT-300-for-Needle--and-Opioid-Free-Sedation-in-Patients-Undergoing-Cataract-Surgery

2. A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR). Accessed October 10, 2024. https://clinicaltrials.gov/study/NCT06383273