FDA Approves Oral Soluble Film Ondansetron Based on MonoSol’s PharmFilm Platform

Collaborating firms aim to use technology to develop OSF Zolmitriptan.

FDA approved Zuplenz®, an oral soluble film (OSF) formulation of ondansetron developed using MonoSol Rx’s PharmFilm® technology. Marketing clearance means MonoSol will receive a $4 million approval fee and a $2 million prelaunch milestone payment from its U.S. commercialization partner Strativa. MonoSol says FDA approval marks the first by the agency for an oral soluble film prescription product. Zuplenz will be available in 4 mg and 8 mg doses for the prevention of nausea caused by postoperative and cancer therapy-related nausea and vomiting

Zuplenz was developed through a collaboration between MonoSol, Switzerland-based Applied Pharma Research, and the latter’s partner Labtec. Approval of the ondansetron OSF in the 16 major EU countries was granted in March via the decentralized procedure. The product is licensed to BioAlliance Pharma for the European market, where it will be marketed as Setofilm®

BioAlliance says estimates by IMS suggest that in 2009 anti-emetic drugs achieved sales of nearly €400 million in the five largest Europe markets, where ondansetron is also the leading drug, holding a 74% slice of the market

The ongoing collaboration between MonoSol, APR, and Labtec also aims to develop a thin film formulation of donepezil. In June the companies extended this partnership even further to include the identification and development of film-formulated products including AstraZeneca’s zolmitriptan migraine therapy, Zomig, which generated revenues of $434 million in calendar year 2009. MonoSol notes zolmitriptan is due to come off patent in 2013.

“Given our shared expertise, this collaboration creates a unique opportunity to broaden the development reach for prescription film products,” comments APR’s CEO Paolo Galfetti. “We look forward to leveraging the capabilities and skills of our partners MonoSol and Labtec as well as the unique attributes of this film technology to advance several drug targets for film delivery.” 

Strativa negotiated U.S. rights to the ondansetron product in June 2008. In January 2010 the firm expanded its collaboration and licensing agreement with MonoSol, including an option to license exclusive U.S. commercialization rights for another three PharmFilm-based OSF products.

MonoSol Rx is developing a portfolio of thin film formulations of existing prescription drugs. These include montelukast sodium for asthma/allergy, epinephrine for severe allergic reaction, and the antidepressant escitalopram oxalate.