Drugs that Melt in Your Mouth: MonoSolRx Has Its Sights Set on Oral Insulin

5/11/11Follow @arleneweintraub

[Corrected 5/12/11, 9:00 am. See below.] The sample packets of the anti-nausea drug that are strewn across the desk of Mark Schobel, CEO of MonoSol Rx, don’t look anything like your standard pharmaceutical product. Each dose of the drug, called ondansetron (Zuplenz)—which is prescribed to cancer patients undergoing chemotherapy and other harsh treatments—is a small, thin piece of film that’s packaged in its own plastic packet. A patient can slip the film in his mouth and it will dissolve in seconds, with no need for water.

MonoSol Rx’s drug-delivery technology, called PharmFilm, is reminiscent of Johnson & Johnson’s popular breath freshener Listerine PocketPaks, except that MonSol Rx’s films have a much more valuable payload: They deliver precise doses of prescription drugs. MonoSol Rx’s business plan is built on the idea that patients would rather let a film dissolve on their tongues or cheeks than have to swallow a pill or take an injection. “We are taking drugs to the next level,” Schobel says. “It’s about convenience, ease of administration, portability—making medication a non-event.”

MonoSol Rx’s version of ondansetron, which was developed in conjunction with two European drug companies and approved by the FDA in July 2010, became the Warren, NJ-based firm’s first marketed product. It helped the tiny pharma company reach a milestone in the fourth quarter of last year: profitability. Now MonoSol Rx is bringing its film into entirely new markets, including diabetes, where it hopes to be the first company to successfully make oral insulin—long the holy grail of the pharmaceutical industry.

MonoSol Rx was spun off from Merillville, IN-based materials maker MonoSol in 2004, and it began engineering a polymer-based, edible film that could dole out uniform doses of medicine. The company secured more than 20 patents covering everything from the composition of the film to the flavoring that’s used to mask medicines’ often bitter tastes. Some MonoSol Rx films dissolve quickly on or under the tongue, while others stick to the inside of the cheek, delivering a drug dosage over a longer period of time.

The company’s journey from a research-based organization to commercial success was far from smooth. After raising $36 million privately in 2006, MonoSol Rx attempted an initial public offering in 2007. But like so many small pharma companies trying to go public in a difficult market, it was forced to abandon its Wall Street dream. “It was a terrible market,” recalls Schobel, adding that the company had to cut its employee count from 100 to 75 and raise debt so it could continue on its development path.

Last year was a banner one for MonoSol Rx. Just six weeks after Zuplenz was approved, the FDA gave the green light to a film combining the drugs buprenorphine and naloxone—a treatment for opioid dependence that MonoSol Rx developed with Richmond, VA-based Reckitt Benckiser Pharmaceuticals, which markets the drug as Suboxone Film.

A spokesperson for Reckitt Benckiser says that in under a year on the market, the film product has captured 37.5 percent of total sales of buprenorphine, which is also available as a dissolving tablet. The film formulation, the spokesperson says, dissolves twice as fast as the tablet. Additionally, she says, it helps lessen public concerns that children … Next Page »

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