September 29, 2025
1 min read
Key takeaways:
- Harrow plans to submit a new drug application in 2027 for sublingual MELT-300 for sedation and analgesia.
- MELT-300 demonstrated positive results in the pivotal phase 3 LOUISE study.
Harrow entered into an agreement to acquire Melt Pharmaceuticals and plans to submit a new drug application for MELT-300, Melt’s lead candidate, to the FDA in 2027.
“MELT-300 integrates seamlessly into Harrow’s existing commercial infrastructure, specifically our surgical team, which calls on and has established relationships with ophthalmologists,” Mark L. Baum, CEO of Harrow, told Healio. “The initial focus will be offering those 700+ accounts who purchased over 150,000 MKO Melts from ImprimisRx last year an FDA-approved and potentially reimbursable product. Knowing precisely which ophthalmologists are familiar with using the compounded formulation provides a clear pathway to successfully launch MELT-300 when it is approved.”
According to a Harrow press release, MELT-300 is a sublingually delivered formulation of a fixed dose of midazolam 3 mg and ketamine 50 mg designed to provide rapid sedation and pain relief. In the pivotal phase 3 LOUISE study, MELT-300 was statistically superior to sublingual midazolam alone (P = .009) and placebo (P .0001), while “the proportion of patients requiring rescue sedation was nearly twice as high for sublingual midazolam compared with MELT-300 (P = .003).”
Additionally, MELT-300 showed positive safety outcomes in a cardiac safety study in which the therapy did not alter normal heart rhythm.
“According to two recent published studies, one reviewing cataract surgeries at Duke and another retrospective analysis of cataract surgeries in the Mayo system, the vast majority of these procedures involve the administration of opioids — and specifically fentanyl,” Baum told Healio. “We also know that a single exposure to fentanyl can initiate a terrible cascade of addiction. MELT-300 has the potential to not only obviate the need for IV sedation in cataract surgery but hopefully nearly eliminate the administration of opioids. Because MELT-300 is a nonopioid, non-IV therapy for procedural sedation, it has the potential to transform patient experiences across a wide range of office-based and outpatient procedures, including cataract surgery, and address the health care system’s growing demand to reduce exposure to opioids.”
