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news.APR Applied Pharma Research (APR), a developer of drugs and drug delivery technology, and its strategic partner Labtec, have completed the pivotal clinical study and its upcoming submission for registration in Europe of their new investigational product Zolmitriptan RapidFilm.
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Zolmitriptan RapidFilm is an oral dispersible film strip formulation of anti-migraine drug Zomitriptan, co-developed in collaboration with Monosol Rx and also based on the RapidFilm technology, a proprietary oral drug delivery technology platform.
Zolmitriptan has the size of 3sqcm and 6sqcm for the 2.5mg and 5mg dosage strengths, respectively and improves patient compliance by dissolving in saliva without water and reduces swallowing difficulties.
APR said that the filing for product approval in Europe is expected in October 2010 through a decentralized procedure starting from one major EU country.
APR CEO Paolo Galfetti said that the development of the ODF form of Zolmitriptan opens new marketing opportunities with further upside potential, if the anticipated switch to OTC of the 2.5mg dosage of Zolmitriptan is accepted in the European countries.
“The Oral Film Strip dosage form is a less invasive way to administer Zolmitriptan than regular tablets and does not require water, thus avoiding potential triggers of nausea and vomiting which are symptoms frequently accompanying migraine,” Galfetti said.
“Zolmitriptan ODF is intended to be a more user friendly form of Zolmitriptan. Expressions of interest from multiple European and US companies have been received for the granting of marketing licenses.”