Melt Pharmaceuticals has announced positive topline results from its Phase III trial of MELT-300, a novel sublingual tablet for procedural sedation during cataract surgery. The study, which included over 530 patients across 13 US clinical sites, demonstrated that MELT-300 achieved statistically significant superiority in providing effective sedation compared to both sublingual midazolam and placebo.
The Phase III trial was conducted under a Special Protocol Assessment agreement with the FDA, designed to meet the requirements for regulatory submission. MELT-300 is a combination of midazolam and ketamine formulated using Catalent's Zydis technology, which allows for rapid sublingual dissolution and absorption.
Superior Sedation with Favorable Safety Profile
The trial data indicated that patients receiving MELT-300 required rescue sedation significantly less often than those receiving sublingual midazolam. Specifically, the proportion of patients needing additional sedation was nearly two-fold higher in the midazolam group compared to the MELT-300 group. The safety profile of MELT-300 was generally comparable to that of the placebo group, suggesting a favorable risk-benefit profile.
Addressing Unmet Needs in Cataract Surgery
Cataract surgery is one of the most frequently performed surgical procedures in the United States, with over 5 million surgeries expected in the coming years. Current sedation protocols often involve intravenous administration of opioids, which can be associated with adverse effects and logistical challenges. MELT-300 offers a non-IV, non-opioid alternative that could simplify the sedation process and improve patient experience.
CEO's Perspective
"We are extremely excited with this robust topline data from our pivotal Phase III study," said Dr. Larry Dillaha, CEO of Melt Pharmaceuticals. "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."
Zydis Technology for Rapid Absorption
Catalent's Zydis technology is known for its rapid disintegration in the mouth, providing a convenient and palatable dosage form. This is particularly beneficial for patients who may have difficulty swallowing, such as geriatric patients. The rapid absorption of MELT-300 via the sublingual route allows for quick onset of sedation, which is crucial in a procedural setting.
Phase II Trial Results
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 demonstrated that MELT-300 was statistically superior in providing procedural sedation across all comparator groups, further supporting its efficacy and potential as a valuable alternative for cataract surgery sedation.
