Harrow Finalizes Acquisition of Melt Pharmaceuticals

Harrow has announced the completion of its acquisition of Melt Pharmaceuticals, which includes the company’s product candidates MELT-210, MELT-300, and MELT-400, developed using the Zydis ODT (oral dissolving tablet) drug delivery platform.

Following the acquisition, Melt will be integrated into Harrow’s operations to support a transition process aimed at advancing the development of MELT-300 toward New Drug Application (NDA) submission, regulatory approval, and potential market introduction.

MELT-300: A Sublingual Formulation for Procedural Sedation

MELT-300 is a patented, sublingually administered formulation containing a fixed dose of midazolam (3 mg) and ketamine (50 mg). It is designed to provide rapid and predictable sedation without the use of intravenous delivery.
Data from phase 2 and phase 3 clinical programs indicated that MELT-300 showed statistical superiority to midazolam alone.

Mark L. Baum, CEO of Harrow, said the program represents an important step in the company’s development pipeline:

“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.”

Baum added:

“We’re excited about MELT-300’s potential to expand procedural sedation options and reduce reliance on opioids across medical specialties. It represents progress for patients and for the US healthcare system.”

MELT-210: Supporting Clinical Studies and Commercial Evaluation

Amir Shojaei, Chief Scientific Officer at Harrow, commented on the company’s second candidate:

“MELT-210 is a sublingual dosage of midazolam (3mg) in the Zydis ODT technology and has been studied in both Phase 2 and Phase 3 trials as a comparator drug in the MELT-300 program. Due to the advantageous characteristics of MELT-210, including its rapid uptake and short half-life, compared to current market alternatives, we believe MELT-210 will have strong commercial potential.”

Amir Shojaei added that Harrow plans to engage with the FDA to determine the next steps for MELT-210 as part of its broader development strategy for the Melt portfolio.

Next Steps Toward Regulatory Submission

Harrow outlined the planned next steps for MELT-300 following completion of the phase 3 program. The company intends to conduct one non-clinical animal study and three pharmacokinetic (PK) studies to complete the data required for an NDA submission, which is expected in the first half of 2027.

If approved, Harrow anticipates a potential FDA decision in the first half of 2028 and a commercial launch in the second half of 2028.