Study on Patented Non-Opioid MKO Melt® Reported in Leading Peer-Reviewed Anesthesia Journal

12/3/2020, 1:30 PM (Source: GlobeNewswire)

NASHVILLE, Tenn., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Harrow Health, Inc. (NASDAQ: HROW) today announced that a study featuring its patented MKO Melt® formulation has been published in the American Association of Nurse Anesthetists (AANA) Journal. Each sublingually administered MKO Melt troche contains 3 mg of midazolam, 25 mg of ketamine, and 2 mg of ondansetron, and is available for institutional purchase through Harrow’s wholly-owned subsidiary, ImprimisRx®.  

ImprimisRx President John Saharek stated, “We are pleased that this study supports the consideration of non-opioid and needle-free MKO Melt as an alternative to traditional IV sedation, which often includes the opioid fentanyl. Further, for those patients with special challenges such as needle-phobia, who have difficult veins to access, or who simply prefer a sublingual alternative to IV administered sedation, the MKO Melt is an option for anesthesia professionals to consider. We look forward to continuing to support anesthesia providers and physicians who are seeking access to alternatives to opioids and needles for their patients.”

The MKO Melt, which has been administered in more than 250,000 cataract surgeries, is compounded in an FDA-registered and inspected outsourcing facility and is protected by patents issued in the United States and abroad.

Summary of the Study

The IRB-approved study compared the effectiveness and equivalency of a sublingual compounded non-opioid MKO Melt troche during monitored anesthesia sedation with traditional IV sedation for maintaining comfort in patients undergoing cataract surgery.   A total sample size of 107 patients were separated into two groups. One group received IV sedation consisting of fentanyl and midazolam (n=54) and the other group received sublingual MKO Melt (n=53).   Sixty percent of the patients in the study were having their first cataract surgery (n=64) and fifty-seven percent of the participants were female (n=61).   The primary endpoint of the study evaluated the comfort level between both groups for nausea, dizziness, pain, and sleepiness following the procedure. The authors of the study stated, “the results show comparable experiences for both groups with equivalency in patient comfort among both women and men.” Further, the authors concluded, “the findings support troche sedation as an effective and equivalent alternative to IV sedation in cataract surgery.”  

A link to the complete narrative of study, which discusses the benefits and limitations of the studied medications, is available here.  

The authors of the study reported no financial relationships with any commercial related entity connected to the study.

About Harrow Health

Harrow Health, Inc. (NASDAQ: HROW) owns a portfolio of ophthalmic pharmaceutical businesses, including ImprimisRx, the nation’s leading ophthalmology outsourcing facility and pharmaceutical compounding business. The company holds large equity positions in Eton PharmaceuticalsSurface Ophthalmics, and Melt Pharmaceuticals. The Company also owns royalty rights in four clinical-stage drug candidates being developed by Surface and Melt. Supported by dedicated employees, Harrow intends to create, invest in and grow paradigm shifting healthcare businesses that put patients first. For more information about Harrow Health, please visit the Investor Relations section of the corporate website by clicking here.

No ImprimisRx compounded formulation is FDA-approved. All ImprimisRx formulations are customizable. Other than drugs compounded at a registered outsourcing facility, all ImprimisRx compounded formulations require a prescription for an individually identified patient consistent with federal and state laws.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Harrow Health’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow Health undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Investor Contact:
ir@harrowinc.com

Source: Harrow Health, Inc. 


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