Harrow has entered into an agreement to acquire Melt Pharmaceuticals, a clinical-stage pharmaceutical company developing non-opioid, non-IV therapies for sedation for medical procedures in the hospital, outpatient, and in-office settings.
Melt’s lead investigational therapy, MELT-300, is a patented, sublingually delivered formulation of a fixed dose of midazolam (3mg) and ketamine (50mg) designed to provide rapid, predictable sedation and analgesia without the need for intravenous administration. This innovative approach has the potential to transform patient experiences across a wide range of office-based and outpatient procedures and address the healthcare system’s growing demand to reduce exposure to opioids.
In November 2024, Melt announced positive topline results from its pivotal LOUISE (Lower Opioid Use and Improve the Sedation Experience) Phase 3 Study, which demonstrated that MELT-300 was statistically superior to both sublingual midazolam alone (P=0.009) and placebo (P=<0.0001) in providing successful procedural sedation. In addition, the proportion of patients requiring rescue sedation was nearly twice as high for sublingual midazolam compared with MELT-300 (P=0.003).
The LOUISE Phase 3 Study was conducted under a Special Protocol Assessment (“SPA”) agreement with the U.S. Food and Drug Administration (“FDA”), which confirmed the study design would adequately support a future regulatory submission. Further, results from a recently completed cardiac safety study indicated that MELT-300 did not alter normal heart rhythm, supporting the therapy’s safety profile.
Harrow plans to submit a New Drug Application (“NDA”) to the FDA in 2027, with a potential U.S. commercial launch in 2028.
Strategic Rationale
- Immediately Accretive Launch: Harrow, through its ImprimisRx subsidiary, has successfully marketed the MKO Melt®, a compounded sublingual sedation product widely used by ophthalmologists for more than a decade, with the product used in over 500,000 cataract surgeries. This long-standing, positive experience, by over 700 U.S. ophthalmologists, provides a strong foundation of physician trust and market familiarity with this mode of sedation delivery. Upon FDA approval of MELT-300, Harrow intends to ensure customer access to an FDA-approved product and discontinue the MKO Melt.
- Market Opportunity: Entry into the multi-billion-dollar U.S. procedural sedation market. MELT-300’s novel formulation has the potential to replace and/or supplement IV sedation in medical interventions, with applications in ophthalmic surgery and potential label expansion opportunities into tens of millions of other procedures annually, including claustrophobia during MRIs, sedation for colonoscopies, dental procedures, gastroenterology procedures, and other interventions.
- Added Diversification: Strengthens Harrow’s perioperative portfolio of surgical solutions and diversifies Harrow’s business as MELT-300 is utilized outside of its core US ophthalmic business.
- Operational Synergies: Harrow’s existing commercial and regulatory infrastructure provides the scale to accelerate Melt’s market introduction and potential to replace opioid-based intravenous sedation during the more than 4,000,000 annual U.S. cataract surgeries.
- Improved Patient Experience: 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.
- Expanded Accessibility: Enables physicians to perform procedures comfortably in office and outpatient settings, reducing reliance on operating rooms.
- Global Application: The MELT 300 product candidate has patents issued in North America, Australia, Europe, Asia, and the Middle East. Harrow intends to identify suitable development and commercialization partners to make this technology available outside the U.S. market.
“We are excited to welcome Melt Pharmaceuticals back into the Harrow family. This acquisition represents another important step in our mission to deliver innovative, patient-focused ophthalmic disease management solutions that go beyond the limitations of traditional care,” said Mark L. Baum, Chief Executive Officer of Harrow. “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. With this acquisition, Harrow continues to strengthen its pipeline of transformative therapies and reinforces our commitment to improving outcomes for patients and providers alike.”
Larry Dillaha, MD, Chief Executive Officer of Melt Pharmaceuticals, added, “Sedation hasn’t changed much over the past few decades. Having demonstrated the clinical superiority of the MELT-300 drug candidate over its individual components, including midazolam, we believe the standards of care for sedation will change when the MELT-300 drug candidate is FDA-approved. By re-joining Harrow, we gain the resources and expertise needed to accelerate our programs and bring MELT-300 closer to the patients and physicians who need it most. Together, we are committed to transforming the state of the art in the massive US and global procedural sedation market.”
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