BioAlliance Pharma files for European marketing authorisation for ondansetron RapidFilm

Published: 18-Feb-2009
Regulatory Research & Development

BioAlliance Pharma, a pharmaceutical company focused on the treatment of infections in cancer and AIDS, has made a European marketing application for ondansetron RapidFilm, a fast-dissolving oral film strip formulation of ondansetron, which has previously been used only in tablet form.


BioAlliance Pharma, a pharmaceutical company focused on the treatment of infections in cancer and AIDS, has made a European marketing application for ondansetron RapidFilm, a fast-dissolving oral film strip formulation of ondansetron, which has previously been used only in tablet form.

This drug is designed to prevent and treat nausea and vomiting induced by chemotherapy and radiotherapy. Ondansetron RapidFilm facilitates administration of the drug and improves efficacy and patient compliance.

The ondansetron film strip uses the RapidFilm drug delivery technology developed jointly by Applied Pharma Research (APR) of Switzerland and Labtec of Germany. The formulation is particularly suitable for patients with nausea or who have trouble swallowing, the company said.

BioAlliance Pharma estimates that the decentralised registration procedure (covering 16 European countries) should take between 9 and 12 months.

Dominique Costantini, BioAlliance Pharma's president and ceo, said the application was a key milestone in the commercialisation of this new product.

"RapidFilm technology aims to provide the quickest, easiest and most patient friendly way for the oral intake of drugs," added APR ceo Paolo Galfetti. "Ondansetron was an ideal candidate to maximise both the patient and market value of such features and we believe BioAlliance is the best partner to bring this opportunity to a successful outcome in the market."

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