Penederm regulatory update

DERM received a non-approvable letter from the FDA for its NDAs for the company's Avita retinoic acid formulations for acne. The letter requested an additional study to document the efficacy of the gel formulation. DERM already has completed an additional efficacy trial on Avita gel in 675 patients, and plans to submit the results to the agency within a week. The company said it believes the study addresses the clinical issue raised by the FDA.

The FDA agreed that one of two trials demonstrated efficacy of the product. However, the agency said a second study did not replicate results of the initial study in one of four measures of efficacy, non-inflammatory lesions. ...