What is CIP-isotretinoin?
CIP-isotretinoin is a form of the drug isotretinoin that provides more consistent absorption that exising isotretinoin products. Isotretinoin is an important medication used to treat severe or persistent forms of acne and other skin conditions. CIP-isotretinoin has recently been approved for use in the United States of America, but is not yet available in other countries (July 2012).
Why is consistent absorption of isotretinoin important?
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. Isotretinoin is often taken by teenagers. Teenage eating habits are typically irregular compared to working-age adults. On May 25th 2012, the US FDA approved CIP-isotretinoin (Absorica™; CIPher Pharmaceuticals Canada), which provides 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 can be taken either with or without food.
CIP-isotretinoin is very similar to isotretinoin (marketed under many brand names by various manufacturers). However, it is not exactly the same as isotretinoin, due to differences in how well the drug is absorbed; CIP-isotretinoin is absorbed well with or without food, while the other isotretinoin products must be taken with food to achieve good absorption.
When is CIP-isotretinoin prescribed?
CIP-isotretinoin is an innovative formulation of the active ingredient isotretinoin and is used for patients at least 12 years of age with severe nodular acne that are unresponsive to conventional therapy, including systemic antibiotics.
What is the usual dose and course of treatment?
In most cases, the recommended dose of CIP-isotretinoin is 0.5 mg to 1 mg per kg of body weight (about 0.23 mg to 0.45 mg per lb) each day, divided into two daily doses. For adults with severe acne or acne limited mostly to the trunk of the body, up to 2 mg per kg (about 0.91 mg per lb) each day, may rarely be prescribed.
In most cases, CIP-isotretinoin is taken for 15 to 20 weeks. A second course may be recommended if the acne is still a problem eight weeks after finishing the first course. Because of the risk of teratogenicity and to minimize fetal exposure, in the United States, CIP-isotretinoin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE™. Under the CIP-isotretinoin REMS, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program.
Women of childbearing potential must use two effective forms of birth control while taking CIP-isotretinoin and may require pregnancy tests during treatment in order to prevent the use of this medication during pregnancy.
In the United States, CIP-isotretinoin can only be:
- prescribed by doctors that are registered in the iPLEDGE program
- dispensed by a pharmacy that is registered with the iPLEDGE program
- given to patients who are registered in the iPLEDGE program and agree to do everything required in the program
Research evidence for CIP-isotretinoin
In a randomised double-blind study involving 925 patients with severe nodular acne, CIP-isotretinoin was as effective as isotretinoin in achieving a 90% reduction in nodular lesions during a period of 20 weeks.
From a safety perspective, the top-line data was positive showing no overall statistical differences in the adverse event profile between the two products. The most frequent side effects that were observed were dry skin and dry lips. In addition, initial statistics on psychiatric disorders, eye disorders, ear disorders, musculoskeletal, vascular disorders, cardiac disorders, and gastrointestinal disorders, illustrate there were no significant differences in the extent of adverse events between CIP-isotretinoin and the reference product.
Certain antibiotics, St. John's wort, or progestin-only birth control pills in combination with CIP-isotretinoin can lead to potentially serious drug interactions. In some cases, these reactions may increase risk for osteoporosis, raised pressure in the head, or other serious problems.