Valeant Pharmaceuticals International's wholly-owned subsidiary, Valeant Canada Ltd, has received notice that the New Drug Submission for Onsolis (fentanyl buccal soluble film) has been approved from the Canadian regulatory authority Health Canada. 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. Onsolis will be the first available fentanyl product with rapid onset of action approved in Canada and is expected to be available for patients in the third quarter of 2010. The product will be commercialized by the joint venture between Meda AB and Valeant Canada Limited (Meda Valeant Pharma Canada Inc.).

"We are excited to receive approval for our first product to come out of our joint venture with Meda," said J Michael Pearson, chairman and chief executive officer. "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."

Canada represents an important market for Onsolis. It is estimated that there are over 700,000 people diagnosed with cancer in Canada, with 30 per cent suffering from pain, and that 65 per cent of these sufferers will also have breakthrough cancer pain.

Onsolis (fentanyl citrate) buccal soluble film is indicated only for the management of breakthrough pain in adult 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.

Patients considered opioid tolerant are those who are taking at least 60 mg/day morphine equivalents for a week or longer. All patients starting treatment with Onsolis must begin with titration from the 200 mcg dose.

This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression could occur in patients not taking chronic opiates. For this reason, Onsolis is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.

Onsolis is intended to be used only by healthcare professionals who are knowledgeable of, and skilled in the use of opioids to treat cancer pain.

Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology.