Melt Pharmaceuticals Secures $24M for Advanced Sedation Tablet Development

Melt Pharmaceuticals has successfully completed a significant financial milestone, securing approximately $24 million through its Series B Preferred Stock financing round. This latest funding round saw contributions from both new and returning investors, setting the stage for the accelerated development of MELT-300, the company's flagship product currently in its phase 3 program.

MELT-300: A Non-IV, Non-Opioid Sedation Solution

MELT-300 is a revolutionary non-IV, non-opioid tablet designed for sublingual administration, offering a unique combination of midazolam (3mg) and ketamine (50mg). Utilizing Catalent’s proprietary Zydis fast-dissolving delivery technology, MELT-300 is engineered to rapidly disintegrate under the tongue, allowing for swift absorption through the sublingual mucosa. This innovative approach to procedural sedation aims to replace traditional needle-based and opioid-dependent methods, particularly in the context of cataract surgeries which number over 4.5 million annually in the U.S. alone.

Phase 3 Program Kickoff and Future Milestones

The phase 3 program for MELT-300 officially began in the first quarter of 2024, with expectations to administer the first patient dosage in the second quarter and project a topline readout by the fourth quarter of the same year. This timeline marks a crucial phase in the product's development and its potential to redefine procedural sedation practices.

Dr. Larry Dillaha, Chief Executive Officer of Melt Pharmaceuticals, articulated the company's vision, stating, “Melt is seeking to drive a paradigm shift in procedural sedation, fulfilling an unmet need to provide a needle- and opioid-free alternative for procedural sedation, especially in cataract surgeries, which are estimated at over 4.5 million procedures in the US. As we continue to develop our patented technologies, we believe we can also impact the more than 100 million short-duration medical procedures nationwide.” He further emphasized the transformative potential of MELT-300, “If approved, we expect MELT-300 will enhance the patient’s experience in all sites of care by offering greater comfort without a needle stick and by reducing exposure to opioids.”

This funding round not only underscores the confidence of investors in Melt Pharmaceuticals’ innovative approach but also highlights the growing demand for safer, more patient-friendly sedation methods in the healthcare industry.