Harrow announced it has entered into a definitive agreement to acquire Melt Pharmaceuticals, the maker of investigational non-opioid, non-intravenous (non-IV) sedation therapies for medical procedures across hospital, outpatient, and in-office settings.
Financial terms of the deal were not disclosed.
The acquisition aims to broaden Harrow’s therapeutic footprint beyond ophthalmology and into procedural sedation, which Harrow describes as area of growing demand as healthcare providers seek to reduce opioid exposure and streamline patient care.
Melt’s flagship investigational product, MELT-300, is a patented sublingual formulation combining midazolam (3 mg) and ketamine (50 mg). Designed for rapid, predictable sedation and analgesia without the need for IV administration, MELT-300 offers the potential to transform patient experiences for a wide range of office-based and outpatient procedures.
According to Harrow, MELT-300's under-the-tongue delivery, using Catalent’s ZYDIS oral dissolving tablet technology—which is used in over 35 FDA-approved products—offers a less invasive, needle-free, non-opioid option that could reduce anxiety, improve comfort, and simplify care.
In November 2024, Melt reported positive topline data from its pivotal LOUISE (Lower Opioid Use and Improve the Sedation Experience) phase 3 Study. Key findings include:
Superior Efficacy: MELT-300 achieved statistically significant superiority over both sublingual midazolam alone (P=0.009) and placebo (P<0.0001) in achieving successful procedural sedation
Reduced Rescue Sedation: Patients receiving sublingual midazolam required nearly twice the rate of rescue sedation compared with those treated with MELT-300 (P=0.003)
Strong Safety Profile: A recently completed cardiac safety study confirmed MELT-300 does not affect normal heart rhythm
The phase 3 trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
Harrow said it expects to submit a new drug application (NDA) for MELT-300 to the FDA in 2027, positioning the therapy for a potential U.S. commercial launch in 2028.
Harrow, through its ImprimisRx subsidiary, has marketed the MKO Melt, a compounded sublingual sedation product used by ophthalmologists for more than a decade, with the product used in over 500,000 cataract surgeries. Upon FDA approval of MELT-300, Harrow intends to ensure customer access to an FDA-approved product and discontinue the MKO Melt.
“MELT-300 has the potential to redefine the standard of care for millions of patients by providing a convenient, non-opioid alternative for procedural sedation. By reducing reliance on opioids, MELT-300 not only addresses a critical public health need but also opens the door to significant market expansion opportunities across a wide range of medical procedures," said Mark L. Baum, Chief Executive Officer of Harrow.
The transaction remains subject to customary closing conditions, including approval by Melt stockholders, excluding Harrow and its affiliates.