Orexo’s Rapinyl™ nearing regulatory decision in Europe
Without consensus among all 25 member states, the product will now be referred for review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), where a majority decision is sufficient to gain approval. The exact timings of the CHMP process are not yet clear, but it seems likely that the approval process will extend into 2008.
“While the process is taking some time, we remain confident in Rapinyl™ and its merits, and optimistic about regulatory approval in the not too distant future” said Zsolt Lavotha, CEO of Orexo.
Rapinyl™ is a product for the treatment of acute pain. The first indication is breakthrough pain in cancer. Rapinyl™ is based on Orexo´s unique proprietary technology for sublingual administration, where a tablet is placed under the tongue and rapidly disintegrates into ordered mucoadhesive units of the active substance. This novel pharmaceutical preparation combines the properties of fast dissolution, quicker onset of action and predictable effect.
The marketing rights for Rapinyl™ are licensed to Kyowa Hakko Kogyo Co. Ltd for the Japanese market, to Endo Pharmaceuticals for the North American market and to ProStrakan Group plc for the European market.
For further information, please contact:
Zsolt Lavotha, President and CEO
Tel.: +46-18 780 88 12
Claes Wenthzel, Executive Vice President and CFO
Tel: +46-18 780 88 44