MELT-300

MELT-300 is a non-intravenous, non-opioid, fixed-dose combination sublingual tablet containing midazolam (3 mg) and ketamine (50 mg). Developed by Melt Pharmaceuticals, it is designed for procedural sedation in patients undergoing cataract surgery and other short medical procedures. The formulation utilizes Catalent's proprietary Zydis® delivery technology, which allows the tablet to dissolve in as little as 3 seconds for rapid absorption across the sublingual mucosa. MELT-300 provides sedation through the synergistic action of midazolam, a GABA-A receptor positive allosteric modulator, and ketamine, an NMDA receptor antagonist, offering a needle-free alternative to traditional intravenous sedation protocols. In pivotal Phase 3 clinical trials, MELT-300 demonstrated statistical superiority in providing sedation compared to sublingual midazolam alone and placebo.

Other names

midazolam + ketamine sublingual tablet