Melt Pharmaceuticals has reported encouraging topline results from its Phase III trial of MELT-300, a non-intravenous, non-opioid sedation tablet for cataract surgery.
The pivotal study’s design, aligned with a Special Protocol Assessment agreement with the US Food and Drug Administration (FDA), supports the objectives necessary for a regulatory submission.
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A tablet that features a combination of midazolam and ketamine, MELT-300 leverages Catalent’s ‘Zydis’ technology for sublingual delivery, dissolving in seconds for rapid absorption.
The trial, involving more than 530 patients across 13 US clinical sites, demonstrated MELT-300’s statistical superiority in providing procedural sedation compared to both sublingual midazolam and placebo.
It revealed that the proportion of patients requiring rescue sedation was nearly two-fold higher with sublingual midazolam than with MELT-300, indicating a significant advantage for the latter.
Additionally, MELT-300’s safety profile was generally comparable to that of the placebo.
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By GlobalDataMelt Pharmaceuticals CEO Dr Larry Dillaha said: “We are extremely excited with this robust topline data from our pivotal Phase III study. These overwhelmingly positive results support our belief that MELT-300, if approved by the FDA, would be a safe and effective non-IV, and non-opioid alternative to current IV-based cataract surgery sedation protocols, which generally involve the administration of opioids.
“With the number of cataract surgeries performed each year in the US expected to exceed five million in the coming years, we believe offering patients and physicians the ability to achieve an adequate sedation level without the need to start an IV or administer opioids is a very attractive proposition.”
Catalent’s fast-dissolve formulation, Zydis, is claimed to be known for its rapid disintegration in the mouth, offering a convenient and palatable dosage form.
This technology is particularly beneficial for patients with swallowing disorders, as well as paediatric and geriatric populations, requiring quick dosing and absorption for various treatments.
In a Phase II trial reported in December 2022, MELT-300 was compared against sublingual placebo, midazolam, and ketamine in over 300 patients undergoing cataract surgery.
The results showed that MELT-300 was statistically superior in providing procedural sedation across all comparator groups.
