A coming, branded formulation of isotretinoin will offer compliance and efficacy advantages not previously available to U.S. dermatologists.
Absorica is a novel, patented brand formulation of isotretinoin marketed in the United States by Ranbaxy Pharmaceuticals Inc. *It will be available by the end of 2012 for the treatment of severe recalcitrant nodular acne.
The new drug, approved by the Food and Drug Administration in May, isn’t just another therapeutic option for dermatologists looking to treat acne – it’s a potential game changer in terms of improving efficacy and preventing relapse, according to Dr. Eric "Billy" Baum of the University of Alabama, Birmingham, who is a member of the speakers’ bureau for Ranbaxy.
Dr. Eric W. Baum
Absorica is not rated as A-B equivalent to Accutane and the other isotretinoins, Dr. Baum said.
"I think that this is going to be a great advantage to dermatologists today," he said in an interview. "They’ll be able to have a type of isotretinoin that they know they are going to see really good results with. They are going to get the high blood levels that they need in order to get the maximum improvement, maximum absorption, and maximum efficacy."
Absorption is the key difference between how Absorica works and how other isotretinoins work, Dr. Baum explained at the meeting sponsored by Skin Disease Education Foundation.
Isotretinoin is highly lipophilic and is a poorly solubilized molecule. As a result, patients don’t get the maximum benefit of the drug unless they take it with a high-fat meal, ideally about 50 grams of fat, according to Dr. Baum. That’s the equivalent of a breakfast of two fried eggs in butter, two strips of bacon, two slices of toast with butter, 4 ounces of hash brown potatoes, and 8 ounces of whole milk, he said. Since isotretinoin is taken twice daily, patients should also eat another high-fat meal at dinnertime, he said.
But most adolescent patients taking isotretinoin don’t eat that type of high-fat diet – in fact, about a third of adolescents don’t eat breakfast at all, he said.
With the traditional form of isotretinoin, only about 40% of the drug was absorbed when patients were fasting. In contrast, with Absorica nearly 70% is absorbed, Dr. Baum said. "There is now a greater likelihood for patients to achieve cumulative targeted doses of isotretinoin in the 20 weeks of treatment, thereby increasing success of treatment and lowering the risk of relapse."
The better absorption with Absorica is due to a patented drug delivery system, which delivers isotretinoin along with fatty molecules, optimizing absorption in the small intestine, Dr. Baum explained.
A phase III trial with more than 900 patients showed no statistical difference in efficacy at 20 weeks between Absorica and Accutane when patients have eaten a high-fat meal. "You get the results that were achieved with the original Accutane under fed conditions with less concern about what patients will actually eat," Dr. Baum said.
There was also no notable difference in psychiatric, gastrointestinal, vascular, cardiac, or ophthalmic side effects between the two formulations, Dr. Baum said, adding that like all isotretinoins, Absorica patients and prescribers are obligated to participate in the iPLEDGE risk management program.
"This is a medication that’s been very highly studied, the largest clinical study on isotretinoin ever completed," he said.
The better rate of absorption is this formulation’s big clinical advantage, which should result in fewer relapses, Dr. Baum said. That could also make the drug more cost effective, because it would cut down on subsequent treatments in the event of relapse.
"It is important to treat isotretinoin patients most effectively in one cycle, if possible," Dr. Baum said. "This is the time where the patient is most motivated and has the most family support to comply with the complicated instructions of isotretinoin and iPLEDGE."
SDEF and this news organization are owned by Frontline Medical Communications.
*CORRECTION (11/07/12): A previous version of this story incorrectly reported when Absorica will be available in the U.S. This version has been updated.