Status Report on Oral Isotretinoin in the Management of Acne Vulgaris: Why All the Discussion about Drug Absorption and Relapse Rates?

Abstract

Oral isotretinoin is a highly successful therapy for severe, refractory inflammatory acne vulgaris (AV) that is indicated especially for patients with multiple nodulocystic lesions. After over 30 years of clinical use, it is apparent that the majority of patients experience clearing of AV with prolonged remission after a course of oral isotretinoin therapy is completed. Multiple reports have shown that recurrence of AV occurs in some patients and is more likely in those who had not achieved adequate cumulative exposure to a total dose of drug, which has been defined as 120 - 150 mg/kg. As the pharmacokinetic profile of orally administered isotretinoin shows that gastrointestinal absorption is highly dependent on administration with a high calorie-high fat meal, it is has been considered that patients who ingest a conventional formulation of oral isotretinoin without an adequate meal or without food at all may be predisposed to a higher rate and earlier onset of recurrence of AV as their cumulative systemic exposure is effectively reduced by up to 60 %. A new formulation of oral isotretinoin uses a technology where isotretinoin is pre-solubilized in a lipid matrix so absorption is not markedly diminished if the patient does not ingest the drug with an adequate meal. As the data analysis on recurrence of AV in patients treated with conventional formulations of oral isotretinoin are retrospective, additional research and vigilant observation are needed to determine if the new formulation will provide better long term outcomes. © 2013 Springer Science+Business Media New York.