Cipher Pharmaceuticals (TSX:DND) has received approval from Health Canada for its new drug submission 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 the second quarter of 2013. The product is administered orally, once or twice daily, for a treatment period of about five months. For severe nodular acne, isotretinoin is the most commonly prescribed medication, with a market size of some $15-million in sales in Canada.
Compared with other currently available isotretinoin products, including the brand original, Accutane, which is distributed by Hoffman-La Roche, Cipher said 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% 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,” CEO Larry Andrews said in a statement.
“The approval of Epuris is a critical milestone in our plans to create a commercial presence in dermatology and other specialty markets in Canada,” he added. “Pre-commercial activities have commenced, including the addition, in the coming months, of a specialized dermatology sales and marketing team in preparation for the launch.”