Melt Pharmaceuticals has dosed the first subject in its Phase III clinical trial of MELT-300 being developed as a needle and opioid-free sedation option for patients undergoing cataract surgery.
A sublingual tablet, MELT-300 combines midazolam and ketamine, aiming to provide a new sedation alternative.
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The randomised, double-blind, three-arm study is designed to assess the product’s safety and efficacy.
In the trial, 528 subjects will be randomised into a 4:1:1 ratio to receive either MELT-300, sublingual midazolam, and sublingual placebo for procedural sedation before undergoing cataract surgery at 14 clinical sites.
Melt anticipates reporting the topline results from the trial in the fourth quarter of this year.
MELT-300 utilises Catalent’s Zydis technology to rapidly dissolve the tablet, allowing for absorption through the sublingual mucosa.
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By GlobalDataThe subject dosing in Phase III follows positive outcomes from the Phase II clinical trial of MELT-300 against sublingual placebo, sublingual midazolam, and sublingual ketamine in more than 300 patients.
MELT-300 demonstrated statistical superiority in providing procedural sedation compared to each of the comparator arms individually in the Phase II trial.
Melt CEO Dr Larry Dillaha said: “Over the past 20 years, a lack of innovation in outpatient procedural sedation has created a significant unmet need, with IV‑administered medications being a procedural mainstay and contributing to an increase in opioid usage.
“We believe that MELT-300 could revolutionise procedural sedation while enhancing the patient’s experience in all sites of care by offering greater comfort without a needle stick and by reducing exposure to opioids.”
“While we are initially targeting sedation during cataract surgery for MELT-300, estimated to be over five million annual procedures in the US in the coming years, we believe with further development and label expansion, MELT-300 could be utilised in over 100 million annual procedures in areas such as dermatology, plastics, dental, gastrointestinal, and emergency rooms.”
