Blog: New Isotretinoin Drug May Address Safety Concerns

Isotretinoin has taken a beating over the last several years. From IBD to suicide, the acne drug has been at the forefront of lawsuits and clinical debate.

Could a new isotretinoin drug be the answer to quelling the drug's saftey concerns?

According to Dr. Hilary E. Baldwin, vice chair of the Department of Dermatology at SUNY-Downstate in Brooklyn, N.Y., the answer could be yes, and a new isotretinoin drug may be just around the corner.

She reported the news at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

She said that a phase III trial of CIP-isotretinoin (Cipher Pharmaceuticals) is wrapping up and results will soon be submitted to the FDA for review.

The double-blind, randomized phase III trial, of over 900 patients with severe recalcitrant nodular acne compared CIP-isotretinoin to commercially available isotretinoin. The drug utilizes Lidose technology which helps enhance absorption of the active ingredient of the therapy.

According to Dr. Baldwin, the drug addresses safety concerns, such as IBD and depression. The gelatin capsules of CIP-istoretinoin help reduce GI irratation and the drug is less food dependent.

Dr. Baldwin said a question she always gets is whether or not iPLEDGE is going to get easier? "No, moving onto the next question," she responded to a room full of laughter.

Phase III CIP-isotretinoin results should be released in the near future. We'll keep you posted!

- Amy Pfeiffer

SDEF and this news organization are owned by Elsevier.