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news.Valeant Canada, a wholly owned subsidiary of Valeant Pharmaceuticals, has received notice that the new drug submission for Onsolis (fentanyl buccal soluble film) has been approved from the Canadian regulatory authority Health Canada.
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Valeant Onsolis is an opioid analgesic indicated only for the management of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their persistent baseline cancer pain.
Valeant claimed that Onsolis is expected to be the first available fentanyl product with rapid onset of action approved in Canada and is expected to be available for patients during the third quarter 2010.
Onsolis uses a delivery system designed to give rapid and reliable delivery of fentanyl. The product consists of a small dissolvable disc for application of fentanyl to the buccal (inner lining of cheek) membranes.
Michael Pearson, chairman and chief executive officer, said: “Breakthrough pain is an unmet medical need in cancer patients in Canada and currently no drug is approved in Canada for this indication. Onsolis uses a patented delivery system designed to provide rapid and reliable delivery of fentanyl for the treatment of breakthrough pain in adult cancer patients.”