Applied Pharma Research (APR) and its partner Labtec, a drug delivery developer, have submitted Zolmitriptan Oral Dispersible Film (ODF) for approval in Europe. The oral dispersible film strip formulation containing the anti-migraine drug Zolmitriptan, is the second prescription product to use the RapidFilm technology and is co-developed in collaboration with Monosol Rx. The product will be manufactured for Europe at Labtec’s production site in Hamburg, Germany.

Ondansetron ODF, the first oral dispersible film strip product, was approved in Europe under the brand name Setofilm by BioAlliance Pharma in March 2010. In July 2010 Monosol Rx gained approval in the U.S. of Zuplenz, the Ondansetron ODF marketed by Strativa Pharmaceuticals.

The companies are also seeking marketing approval by the FDA. An IND is expected to be filed during 1Q11. The product will compete with Astra Zeneca’s Zomig, which is subject to patent expiry in 1Q12.