Harrow announced that it has completed the acquisition of Melt Pharmaceuticals, a clinical-stage pharmaceutical company pioneering non-opioid, non-IV therapies for sedation for medical procedures. Melt’s product candidates, MELT-210, MELT-300, and MELT-400, are based on the proprietary Zydis oral dissolving tablet drug delivery platform.

With global patent coverage and potential applications in ophthalmology, gastroenterology, dental care, and other outpatient procedures requiring sedation or anxiety management, Melt’s drug candidates position Harrow to enter the US and global procedural sedation and anxiety market.

Melt Pharmaceuticals will be fully integrated into Harrow’s operations to ensure a seamless transition and accelerate progress toward NDA submission, approval, and market launch of its lead product candidate, MELT-300.

MELT-300 builds on the real-world experience with MKO Melt—a compounded sublingual sedation product sold by Harrow’s ImprimisRx subsidiary and currently administered by more than 800 US ophthalmic institutions, primarily for cataract surgery. MELT-300 is a patented, sublingually delivered formulation of 3 mg midazolam and 50 mg ketamine designed to provide rapid, predictable sedation without the need for intravenous administration. The MELT-300 phase 2 and phase 3 trials demonstrated statistical superiority to midazolam alone.

“The development of MELT-300 marks a defining milestone for Harrow—our first product taken from ideation to the brink of commercialization. I still remember the first call we received about this novel concept of non-IV, non-opioid sedation, and the immediate sense that it could truly change the patient experience for procedural sedation,” said Mark L. Baum, Chief Executive Officer of Harrow. “We’re incredibly excited about MELT-300’s potential to transform procedural sedation, reduce opioid exposure, and expand safe, accessible sedation options across medical specialties.”

Having completed the phase 3 program, Harrow’s focus now turns to advancing MELT-300 toward FDA approval and commercialization. To support the New Drug Application (NDA) filing, Harrow will initiate one non-clinical animal study and three pharmacokinetic studies.