FDA Oks Cip-Isotretinoin for Severe Recalcitrant Nodular Acne

Megan Brooks

Disclosures

May 30, 2012

May 30, 2012 — The US Food and Drug Administration (FDA) has approved cip-isotretinoin, a novel, patented brand formulation of the currently available acne medication isotretinoin, Cipher Pharmaceuticals announced this week.

Cip-isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. It is expected to be available in the United States in the fourth quarter of 2012 under the brand name Absorica.

Better Absorption

In comparison with current isotretinoin formulations on the market, cip-isotretinoin uses Cipher's patented Lidose drug delivery system, which the company says offers more precise, consistent, and uniform drug delivery than currently available isotretinoin.

In phase 1 clinical studies, cip-isotretinoin demonstrated a "significant competitive advantage in the treatment of severe, recalcitrant nodular acne," the company notes on its Web site.

"A major issue for existing isotretinoin products is patient compliance, as the active ingredient should be taken with a high-fat meal to ensure consistent absorption," the company explains. "Teenage eating habits are typically irregular compared to working-age adults."

It continues, "Cip-Isotretinoin has been proven to provide a more consistent absorption under fed and fasted conditions, compared to existing isotretinoin products that exhibit a 65% reduction in absorption under fasted conditions. Cip-Isotretinoin offers more consistent absorption day-in and day-out over the course of a typical 3- to 5-month treatment period."

In 2011, Cipher completed a pivotal phase 3 randomized double-blinded trial comparing the safety profile of cip-isotretinoin with an FDA-approved, commercially available isotretinoin product. The safety, efficacy, and population pharmacokinetic data generated from this study formed the basis of the company's regulatory approval application in the United States.

Cip-isotretinoin is a "valuable option for the dermatologist and patients who need treatment for severe recalcitrant nodular acne," Venkat Krishnan, senior vice president and regional director, Americas, for Ranbaxy Laboratories Inc, said in a statement. Cipher Pharmaceuticals is partnering with Ranbaxy Laboratories Inc to launch the product in the US market.

Cip-isotretinion is currently under review by Health Canada, and Cipher Pharmaceuticals says it anticipates a decision in the first quarter of 2013.

processing....