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

According to Harrow, MELT-300 builds on more than a decade of real-world experience with MKO Melt—a compounded sublingual sedation product sold by Harrow’s ImprimisRx subsidiary and currently administered by US ophthalmic institutions, primarily for cataract surgery. As a potential FDA-approved successor, MELT-300 is a patented, sublingually delivered formulation of a fixed dose of midazolam (3 mg) and ketamine (50 mg) designed to provide rapid, predictable sedation without the need for intravenous administration. The MELT-300 phase 2 and phase 3 clinical programs previously demonstrated statistical superiority to midazolam alone, the company said.

According to Harrow, the MELT-300 program was the subject of a Special Protocol Assessment, confirming that the completed phase 3 study design, statistical approach, and endpoints adequately support a future regulatory submission. Having completed the phase 3 program, Harrow said it will now turn to advancing MELT-300 toward FDA approval and commercialization. As part of that plan, Harrow said that 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. In support of an NDA filing, Harrow said it will be initiating 1 non-clinical animal study and 3 PK studies to generate the balance of the data necessary for an NDA package.

In addition, Harrow said that in H1 2027 that it will prepare and submit the NDA for MELT-300, and in H1 2028, the company will collaboratively engage with the FDA through the review process, with potential approval in the first half of 2028. Additionally, in H2 2028, the company said it wouldleverage its existing commercial infrastructure and MKO Melt customer network to execute launch preparations—including manufacturing scale-up, packaging, supply-chain validation, reimbursement, market-access planning, and more.

Finally, Harrow said, it will build on the company's established ophthalmic footprint to drive adoption initially in cataract and other ophthalmic procedures, followed by expansion into additional outpatient and in-office settings where opioid-free, needle-free sedation can improve patient experience and workflow efficiency. GP