Isotretinoin is indicated for treating severe recalcitrant nodular acne; approved dosage of 1 mg/kg/d is typically prescribed for 20 weeks to achieve a cumulative dose of 120 mg/kg to 150 mg/kg. Cumulative doses falling short of this range have been associated with higher relapse rate and the need for additional treatment.1 One factor that could possibly influence the outcome of isotretinoin therapy is failure to take it with food, particularly fat. Isotretinoin is poorly solubilized in the gastrointestinal (GI) tract in the absence of food. Recently, the Food and Drug Administration (FDA and Health Canada) approved a new formulation of isotretinoin that uses Lidose technology to improve bioavailability of poorly soluble products.
Isotretinoin-Lidose is designed to increase the absorption of isotretinoin in the absence of meals, which was demonstrated in previous pharmacokinetic studies (Unpublished data, Cipher Pharmaceuticals Inc.). A drug with less dependence on the presence of dietary fat in the gut may have a different safety profile. To determine if the safety of isotretinoin-Lidose is comparable and its efficacy is noninferior to that of food-dependent generic isotretinoin formulations, the present trial compared these formulations when both were administered twice daily with meals, as recommended for the comparator formulation of isotretinoin. This study, one of the largest to assess any formulation of isotretinoin, is highly relevant in today’s treatment of severe acne, as it closely monitored psychiatric- and bone-related adverse events in addition to evaluating isotretinoin efficacy in nearly 1000 patients.
This Phase III trial was a multicenter (49 sites), double-blind, randomized, parallel-group, noninferiority study that compared the safety and efficacy of isotretinoin-Lidose with a food-dependent generic isotretinoin product in patients with severe recalcitrant nodular acne. The study protocol was reviewed and approved by the Institutional Review Boards/Independent
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