Harrow (NASDAQ: HROW) has recently closed the acquisition of Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company specializing in non-opioid, non-IV therapies for sedation during medical procedures. Melt's product candidates, including Melt-210, Melt-300, and Melt-400, are based on the proprietary Zydis® ODT drug delivery platform.
Melt-300, a sublingually delivered formulation of a fixed dose of midazolam (3mg) and ketamine (50mg), represents a transformative opportunity for Harrow. The innovative approach to sedation offered by Melt-300 has the potential to transform patient experiences across a wide range of office-based and outpatient procedures, addressing the healthcare system’s growing demand to reduce exposure to opioids.
In addition to Melt-300, Harrow's clinical development team is also excited to advance the Melt-210 drug candidate in procedural sedation. Melt-210, a sublingual dosage of midazolam (3mg) in the Zydis ODT technology, has been studied in both phase 2 and phase 3 trials as a comparator drug in the Melt-300 program. Due to its advantageous characteristics, including rapid uptake and short half-life compared to current market alternatives, Melt-210 is anticipated to have strong commercial potential.
Following the completion of the phase 3 program, Harrow's focus is now on advancing Melt-300 toward FDA approval and commercialization. The company is preparing to submit the New Drug Application (NDA) for Melt-300 in the first half of 2027, with potential regulatory approval expected in the first half of 2028. Harrow aims to leverage its existing commercial infrastructure and customer network to execute launch preparations, including manufacturing scale-up, packaging, supply-chain validation, reimbursement, and market-access planning.
The next steps position Melt-300 to become the first FDA-approved, non-opioid, non-IV sublingual sedation therapy in the U.S., representing a significant growth opportunity for Harrow and a major advancement in patient-centric procedural care.
Harrow, Inc. (NASDAQ: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products addressing various eye conditions. The company was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. As a result of these announcements, the company's shares have moved -1.23% on the market, and are now trading at a price of $40.29. For more information, read the company's full 8-K submission here.
