Imprimis Jumps: Secures Patent for Non-Opioid Compound

Imprimis Pharmaceuticals secured a patent that protects its non-opioid sublingual product MKO Melt compound formulation and investors are pleased.

Shares of Imprimis shot up nearly nine percent in pre-market trading to $1.94. The stock closed at $1.78 on Monday.

Mark L. Baum, chief executive officer of San Diego-based Imprimis, said the patent will cover the MKO (midazolam, ketamine, and ondansetron) Melt formulation as well as "a variety of other versions of midazolam and ketamine combinations" that the company intends to make available to address unmet patient needs. 

The MKO Melt formulation was first made available in 2015. The treatment can be acquired without an individual prescription from Imprimis’ FDA Registered 503B Outsourcing Facility. The MKO Melt can be purchased for $15 per troche. MKO Melt is placed under a patient’s tongue and typically dissolved within a few minutes, which administers the necessary pain treatment. Since it first hit the market, MKO Melt has been dispensed as a compounded formulation more than 70,000 times. The formulation is used primarily before and during cataract surgery. However, Imprimis anticipates that its MKO Melt formulation has numerous uses beyond cataract surgery. The company speculated that there are "likely more than 100 million annual procedures" performed in the United States that could benefit, including dental, obstetric and gynecological procedures.

"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." John Berdahl, an ophthalmologist and inventor of the MKO Melt, said in a statement.

Imprimis has a history of offering inexpensive options to high-priced drugsthrough its compounded formulas. Imprimis is perhaps best known for offering a compound of pyrimethamine and leucovorin as a low-cost alternative to Daraprimfollowing Martin Shkreli’s 2015 decision to increase the price of the drug by 5,000 percent. In addition to Daraprim, Imprimis has developed tiopronin delayed release compounded formulations as a lower-cost alternative to the orphan drug Thiola, used for the treatment of cystinuria.

Imprimis' MKO Melt compounded formulation is the subject of two IRB-approved clinical studies, the company said this morning. The first study is a study of 724 cataract patients. The study was completed, and data is being compiled for peer-review. The second is a National Institutes of Health study that will follow patients who underwent cataract surgery with either traditional IV anesthesia or oral anesthesia. The study will evaluate their comfort ratings, then determine if their comfort correlates to the type of anesthesia they received. A third study, related to the pharmacokinetics of the MKO Melt, is being planned for completion this year, the company said.

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