Non-opioid IV-free procedural sedation and pain relief could aid in the battle against opioid abuse
San Diego, CA – March 27, 2018 — Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), an ophthalmology- focused pharmaceutical company, today announced it has secured a patent covering the company’s innovative MKO (midazolam, ketamine, and ondansetron) Melt® compounded formulation from the US Patent and Trademark office. US Patent 9,918,993 B2 entitled “PHARMACEUTICAL COMPOSITIONS FOR ANESTHESIOLOGICAL APPLICATIONS” was issued on March 20, 2018.
Mark L. Baum, CEO of Imprimis, stated, “We are pleased to have been granted this patent which covers our MKO Melt® formulation and a variety of other versions of midazolam and ketamine combinations we intend to make available to address unmet patient needs. Since we first made the MKO Melt available in 2015, it has been dispensed as a compounded formulation over 70,000 times, used primarily prior to and during cataract surgery.” John Berdahl, MD, board-certified ophthalmologist and co-inventor of the MKO Melt, added, “We have completed more than 10,000 cataract surgeries using the MKO Melt and have had great success with it. We have found that it offers unique benefits to patients who may not be well suited for traditional IV sedation. I am pleased it is now protected by this newly issued patent, and potentially, other procedural sedation patent applications that remain pending.”
Imprimis believes that beyond cataract surgery, there are likely more than 100 million annual procedures in the US ranging from dental, obstetric and gynecological, medical imaging procedures (such as MRIs and CAT scans), vasectomies, colonoscopies, dermatological, plastics procedures, orthopedic, otolaryngological, podiatry, emergency room, urology, and psychiatric that may benefit from an IV-free and opioid-free formulation.
MKO Melt Clinical Studies
Imprimis’ MKO Melt compounded formulation is the subject of two IRB-approved clinical studies. The first is a prospective, three arm, randomized double blind investigator initiated study of 724 total patients undergoing cataract surgery. This study has been completed and the manuscript and accompanying data is being prepared for submission for peer-review. The second is a National Institutes of Health (NIH) funded prospective randomized double-blinded study that will follow patients receiving cataract surgery with either traditional IV anesthesia or oral anesthesia, evaluate their comfort ratings, then determine if their comfort correlates to the type of anesthesia they received. This study, which is expected to be completed in 2018, is being conducted by a major midwestern US healthcare system. A third study, related to the pharmacokinetics of the MKO Melt, is being planned for completion during 2018.
For more information and to order the MKO Melt compounded formulation, please visit www.IVFree.com.
For more information about procedural sedation, please visit here.
About Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is dedicated to making high quality innovative medications accessible and affordable in all 50 states. The company’s flexible business model allows a drug to be compounded or developed as an FDA-approved product through one of its subsidiaries or spin- out companies. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com.
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 Imprimis’ 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, Imprimis 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.
Imprimis’s MKO Melt is a compounded formulation and not FDA-approved. Other than drugs compounded at a registered outsourcing facility, all Imprimis compounded formulations require a prescription for an individually identified patient consistent with federal and state laws.
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Source: Imprimis Pharmaceuticals, Inc.