Cipher Pharmaceuticals Inc., a growing specialty pharmaceutical company,  has received Health Canada's approval for its new drug submission (NDS) for Epuris, a novel, brand formulation of the acne medication isotretinoin, for the treatment of severe acne. Cipher expects to launch Epuris in Canada in Q2 2013.

Epuris is indicated for the treatment of severe, recalcitrant, nodular acne in patients 12 years of age and older. The product is available by prescription and is administered orally, once or twice daily, for a treatment period of approximately five months. Compared to the other currently available isotretinoin products (including the brand original, Accutane, distributed by Hoffman- La Roche Ltd.), Epuris provides more reliable absorption under varying dietary conditions. While the rate and the extent of absorption of Epuris is equivalent to Accutane under high-fat, fed conditions, Epuris is 83 per cent more bioavailable than Accutane when taken without food.

"We are pleased to make Epuris available as a valuable option to Canadian dermatologists and patients who require treatment for severe recalcitrant nodular acne," said Larry Andrews, president and CEO of Cipher. "The approval of Epuris is a critical milestone in our plans to create a commercial presence in dermatology and other specialty markets in Canada. Pre-commercial activities have commenced, including the addition, in the coming months, of a specialised dermatology sales and marketing team in preparation for the launch in Q2 2013."

Acne affects more than five million Canadians, with 80 per cent of those between the ages of 12 and 242. Although acne is most commonly seen as a stage of puberty, it can also begin in adulthood, with 75 per cent of adult acne occurring in women. For severe nodular acne, isotretinoin is the most commonly prescribed medication, with a market size of approximately $15 million in sales in Canada.