Harrow announced plans to acquire Melt Pharmaceuticals, a clinical-stage company developing non-opioid, non-IV sedation therapies for medical procedures. The acquisition is subject to standard closing conditions, including approval from Melt stockholders.
Melt’s lead candidate, MELT-300, is a sublingual formulation combining midazolam and ketamine, designed to provide fast, predictable sedation and pain relief without intravenous administration. The therapy aims to improve patient experiences across outpatient and office-based procedures while reducing reliance on opioids.
In November 2024, Melt reported positive Phase 3 LOUISE trial results, showing MELT-300 outperformed sublingual midazolam and placebo in procedural sedation, with fewer patients needing additional sedation. The study was conducted under a Special Protocol Assessment with the FDA, supporting future regulatory approval. Cardiac safety studies also indicated MELT-300 does not affect normal heart rhythm.
Harrow plans to submit a New Drug Application to the FDA in 2027, targeting a potential U.S. launch in 2028.
Read the full press release here.
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