The first patient has been dosed in a pivotal phase 3 program of a needle- and opioid-free sedation for cataract surgery, according to a press release from Melt Pharmaceuticals.
MELT-300, the company’s lead product candidate, combines fixed doses of midazolam 3 mg and ketamine 50 mg administered sublingually as a rapidly dissolving tablet.
The randomized, double-masked, three-arm clinical trial will evaluate the safety and efficacy MELT-300 compared with sublingual midazolam and sublingual placebo for procedural sedation in 528 patients undergoing cataract surgery at 14 clinical sites.<