IV- and opioid-free cataract surgery sedation tablet shows positive phase 3 results
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Key takeaways:
- MELT-300 is a single tablet delivered sublingually for sedation during cataract surgery.
- It was statistically superior compared with sublingual midazolam and sublingual placebo.
MELT-300 demonstrated in a pivotal phase 3 study positive topline results in IV- and opioid-free procedural sedation for patients undergoing cataract surgery, according to a press release from Melt Pharmaceuticals.
“Building on the success of MKO Melt, a widely used compounded formulation that laid the groundwork for MELT-300, this innovative product represents a transformative step forward in procedural sedation for patients during cataract surgery,” Larry Dillaha, MD, CEO of Melt Pharmaceuticals, told Healio.
MELT-300, a single tablet delivered sublingually using Catalent’s Zydis delivery technology, is a fixed dose combination of midazolam 3 mg and ketamine 50 mg. It is designed to dissolve “in as little as 3 seconds, allowing absorption of the active ingredients across the sublingual mucosa,” the release said.
“For many patients, the most anxiety-inducing aspect of the procedure is the insertion of an IV and the use of opioids,” Dillaha said. “By being IV- and opioid-free, MELT-300, if approved, will not only alleviate this anxiety but also streamline the surgical process for both patients and providers.”
In the clinical trial, 530 patients at 13 clinical sites in the U.S. were randomly assigned to sedation with MELT-300, sublingual midazolam or sublingual placebo. MELT-300 showed statistically superior results compared with sublingual midazolam and placebo (P = .009 and P < .001, respectively) in providing successful sedation. In addition, nearly twice as many patients who received sublingual midazolam required rescue sedation compared with those who received MELT-300 (P = .003).
MELT-300 demonstrated a positive safety profile that was comparable to placebo, according to the release.
“We believe MELT-300 has the potential to set a new standard of care in procedural sedation, starting with cataract surgery and extending to numerous other applications through strategic lifecycle management,” Dillaha said.
Healio reported in April that Melt Pharmaceuticals closed $24 million in Series B financing to advance the development of MELT-300.
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