PecFent Against Breakthrough Pain

CHMP endorsed the admission of against breakthrough pain of Archimedes Pharma reading, UK, July 14, 2010: the Committee for medicinal products for human use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to the product. Archimedes Pharma (Archimedes”), one of the leading specialty pharmaceutical company, developed the innovative fentanyl nasal spray. The CHMP endorsed the market admission of in the countries of the European Union for the treatment of cancer breakthrough pain. Cancer breakthrough pain are unpredictable and sudden onset, extremely sharp pain attacks that occur despite a basic pain therapy. To Jeffrey H.

Buchalter, President and Chief Executive Officer of Archimedes Pharma: this is a defining moment for the patients and Archimedes Pharma, since for this indication only a few effective drugs available, although up to 95% of all cancer patients are affected. Also, the opinion represents a major Milestone in the development of our position as a leading European specialty pharmaceutical company. Our clinical research program has delivered excellent results, and we are happy to be able to offer this new treatment option to patients in Europe after the marketing authorisation as quickly as possible.” Contains fentanyl citrate in the form of an aqueous solution. Thanks to the proprietary PecSys technology Archimedes Pharma, the fentanyl stays longer in contact with the nasal mucosa and can be absorbed quickly, but controlled the systemic blood circulation. The opinion is based on the results of the extensive clinical development program for, which included three phase III studies, including a study with an active comparator and a comprehensive long-term study of security and acceptance. More than 650 patients and over 100 testing centers in 13 countries on four continents took part in the program, for example, in the United States, in the United Kingdom, as well as in Germany, France, Spain and Italy. Archimedes Pharma the approval as a new drug (new drug application NDA) for PecFent in the U.S.



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