Harrow Inc. Expands Portfolio with Melt Pharmaceuticals Deal

Harrow Inc. Makes Strategic Move to Acquire Melt Pharmaceuticals

Harrow, a prominent provider of ophthalmic disease management solutions in North America, has recently announced its agreement to acquire Melt Pharmaceuticals, Inc., a pioneering clinical-stage pharmaceutical company known for its innovative non-opioid, non-IV therapies for procedural sedation. This transaction is a significant step forward for Harrow and aligns with its mission to enhance patient care and address the long-standing issues associated with opioid use in medical settings.

Revolutionizing Patient Sedation with MELT-300

Melt's flagship product, MELT-300, is an exciting new therapy designed to provide effective sedation without requiring intravenous administration. This product combines a fixed-dose formulation of midazolam (3mg) and ketamine (50mg) delivered sublingually, allowing for quicker and more predictable sedation outcomes in various medical procedures. Such advancements are particularly vital in an era where the medical community seeks alternatives to opioids, addressing both patient safety and comfort effectively.

The Benefits of MELT-300

Proven Results

The pivotal LOUISE Phase 3 Study showcased impressive results, with MELT-300 demonstrating superiority over both sublingual midazolam alone and placebo in achieving successful procedural sedation. Notably, the study revealed a significant reduction in the need for rescue sedation, highlighting the therapy's potential advantages over traditional sedation methods.

Future Regulatory Submission Plans

Harrow intends to submit a New Drug Application (NDA) to the FDA for MELT-300 with the aim of commercial launch in the coming years. This proactive approach illustrates Harrow's commitment to bringing this innovative solution to market and redefining sedation practices.

Strategic Advantages for Harrow

Harrow's acquisition of Melt Pharmaceuticals is more than just a business move; it's a strategic decision that unlocks several important advantages:

Market Expansion

The entry into the multi-billion-dollar U.S. procedural sedation market presents a substantial opportunity for growth. MELT-300 has the potential to not only replace but also complement IV sedation across various medical interventions.

Enhancing Patient Experience

MELT-300 facilitates a more patient-friendly experience with its under-the-tongue delivery method, minimizing the discomfort and anxiety typically associated with sedatives. This innovation is expected to simplify care and improve comfort during procedures.

Global Reach

With patents secured in key regions around the world, including North America and Europe, Harrow aims to partner with international entities to extend MELT-300's availability and benefit patients globally. Such initiatives underline the company's long-term vision and commitment to addressing global health challenges.

Leadership Insights

Mark L. Baum, the CEO of Harrow, expressed excitement over the acquisition, emphasizing its role in expanding Harrow's portfolio of advanced treatment options. He believes that MELT-300 will not only enhance patient outcomes but also significantly broaden the market opportunities available to the company.

Similarly, Dr. Larry Dillaha, CEO of Melt Pharmaceuticals, highlighted the groundbreaking nature of MELT-300, asserting that FDA approval would mark a paradigm shift in sedation protocols, benefiting patients in the U.S. and beyond.

About Harrow

Harrow Inc. (NASDAQ: HROW) is dedicated to improving the lives of patients through innovative ophthalmic disease management solutions. With a robust portfolio addressing various ocular conditions, the company is committed to delivering effective and affordable therapies that enhance clinical outcomes.

About Melt Pharmaceuticals

Melt Pharmaceuticals, Inc. focuses on developing unique non-IV, non-opioid sedation and analgesic treatments. Aimed at improving procedural sedation, their approach reflects a commitment to innovation and patient-centered care.

Frequently Asked Questions

What is Harrow acquiring from Melt Pharmaceuticals?

Harrow is acquiring Melt Pharmaceuticals to gain access to innovative non-opioid sedation therapies, including the lead product MELT-300.

How does MELT-300 work?

MELT-300 is a sublingual formulation combining midazolam and ketamine, providing rapid sedation without intravenous delivery.

When is the expected FDA submission for MELT-300?

Harrow plans to submit a New Drug Application for MELT-300 to the FDA, aiming for a launch around 2028.

What are the potential market applications for MELT-300?

MELT-300 can be used in various medical procedures, including ophthalmic surgeries, dental procedures, and more, potentially revolutionizing sedation in these settings.

How will this acquisition impact Harrow's business strategy?

This acquisition allows Harrow to diversify its product offerings, expand into new markets, and improve patient experiences within its current surgical portfolio.

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