Harrow Completes Acquisition of Melt Pharmaceuticals, Advancing Zydis® ODT-Based Non-Opioid, Non-IV Sedation Candidates Including MELT-300

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PharmaCircleSupervisionMeasurement DisplayIndicates:Recently from the United StatesOphthalmologyDisease management solutions provider Harrow Company (NASDAQ: HROW) has completed the acquisition of Melt Pharmaceuticals, Inc. Melt Pharmaceuticals is a clinical-stage pharmaceutical company focused on developingNon-Opioid, Non-Intravenous Sedation Therapy, suitable for sedation needs during medical procedures in hospital, outpatient, and clinic settings.

The candidate drugs of the company, MELT-210, MELT-300, and MELT-400, are all based on the proprietary Zydis® orally disintegrating tablet (ODT) delivery platform. The completion of this acquisition marks a strategic expansion of Harrow's product portfolio and reinforces its commitment to delivering innovative therapies to improve patient outcomes.

Melt Pharmaceuticals' candidate drugs (including MELT-300) are protected by global patents and have potential applications in multiple fields such as ophthalmology, gastroenterology, and dentistry. They can meet the needs of various outpatient procedures requiring sedation or anti-anxiety, such as diagnostic imaging, endoscopy, and pre-anesthetic preparation. This strategic layout will help Harrow enter the multi-billion-dollar U.S. and global markets for procedural sedation and anti-anxiety.

MELT-300 represents a transformative opportunity, developed based on over a decade of real-world application experience with MKO Melt®, a compounded sublingual sedative drug sold by ImprimisRx, a subsidiary of Harrow. The drug is currently used by more than 800 ophthalmic institutions in the U.S., primarily for cataract surgery. As a potential FDA-approved alternative,MELT-300 is a patented sublingual formulation containing a fixed dose of midazolam (3 mg) and ketamine (50 mg)., providing rapid and predictable sedation effects without the need for intravenous injection. Previous MELT-300 Phase II and Phase III clinical trials have confirmed that its efficacy is statistically superior to midazolam alone. The innovative sedation regimen adopted by this drug is expected to transform the patient experience in various outpatient and clinic procedures, meeting the growing demand of healthcare systems to reduce opioid exposure such as fentanyl.

Halo CEO Mark L. Baum stated: "The development of MELT-300 represents a milestone achievement for Halo — this is our first product to advance from conceptualization to the cusp of commercialization. I still recall the first call I received about this novel non-intravenous, non-opioid sedation solution and immediately recognized its potential to truly transform the patient experience in procedural sedation. From participating in early formulation development, supporting and funding clinical trials, to now conducting the remaining pharmacokinetic (PK) studies and preparing to submit our first New Drug Application (NDA) — this journey highlights Halo's ability to identify promising opportunities early and create substantial value through efficient execution. We are incredibly excited about the potential of MELT-300 to revolutionize procedural sedation, reduce opioid exposure, and expand safe and accessible sedation options across various medical specialties. This is not only a scientific or commercial achievement but also a significant step forward for patients and the U.S. healthcare system."

Amir Shojaei, Chief Scientific Officer of Melt Pharmaceuticals, added, "In addition to the MELT-300 program, our clinical development team is also advancing procedural sedation studies for the MELT-210 candidate, a drug we have rarely mentioned before but remains one of the key considerations in this acquisition. MELT-210 is a sublingual formulation of midazolam (3 mg) utilizing Zydis® orally disintegrating tablet technology and has completed Phase II and III trials as a comparator drug within the MELT-300 program. Compared with similar products currently on the market, MELT-210 offers advantages such as rapid absorption and a short half-life, which we believe gives it strong commercial potential. We look forward to discussing the next steps of this advanced drug development program with the FDA and bringing the second drug in the Melt portfolio to market at the appropriate time."

Lawrence Woodard, MD, Medical Director of Omni Eye Services of Atlanta, stated: "I have relied on MKO Melt for many years because it meets the dual needs of clinicians and patients — effective sedation without injections or opioids. Its procedural efficiency and safety make it a cornerstone in our operating rooms. The advancement of the innovative MELT-300 towards FDA approval further underscores its significance, not only in ophthalmology but also across various outpatient and clinical procedures. Beyond individual healthcare facilities, the societal impact of reducing opioid exposure while expanding access to safe and convenient sedation services could be immense."

MELT-300 Follow-up Plan

The MELT-300 project has received Special Protocol Assessment (SPA) certification, confirming that the completed Phase III study design, statistical methods, and endpoints are sufficient to support future regulatory submissions. Upon completion of the Phase III trial, Melt Pharmaceuticals, Inc.'s current focus has shifted toward advancing the FDA approval and commercialization process for MELT-300.

• Integration into the Harrow System: Melt Pharmaceuticals will be fully integrated into Harrow's operational system to ensure a seamless transition, accelerating the submission, approval, and market launch of new drug applications.
• Supporting Research: To support the submission of the new drug application, Harrow will initiate a non-clinical animal study and three pharmacokinetic studies to obtain the remaining data required for the new drug application dossier.
• New Drug Application Submission (First Half of 2027): Prepare and submit the new drug application for MELT-300.
• Regulatory Review and Approval (First Half of 2028): Collaborate with the FDA during the review process, with approval expected in the first half of 2028.
• Commercialization Readiness and Launch (Second Half of 2028): Leverage Harrow’s existing commercial infrastructure and MKO Melt’s customer network to advance launch preparations, including production scale-up, packaging, supply chain validation, reimbursement applications, and market access planning.
• Market Expansion Strategy: Building on the established ophthalmic layout in Harrow, first promote the application of this drug in cataract and other ophthalmic procedures, then expand to more outpatient and clinic scenarios where opioid-free, injection-free sedation can improve patient experience and process efficiency.

Through the above follow-up plan, MELT-300 is expected to become the first non-opioid, non-intravenous sublingual sedation therapy in the United States to receive FDA approval, bringing significant growth opportunities to Melt Pharmaceuticals while marking a major advancement in patient-centered procedural healthcare.

More views: https://pharma.bcpmdata.com/，Melt Pharmaceuticals Database

Reference:

NMPA/CDE；

Melt PharmaceuticalsAccording to the database, https://pharma.bcpmdata.com/；

FDA/EMA/PMDA；

harrow.com；https://www.harrow.com/news-releases/news-release-details/harrow-announces-closing-acquisition-melt-pharmaceuticals

; etc.