ABSORICA Is Designed Unlike Any Other Isotretinoin
ABSORICA has no generic equivalent. In fact, it is the only isotretinoin uniquely designed to be taken with or without a meal.1,3
ABSORICA CAN BE TAKEN WITH OR WITHOUT MEALS1
ABSORICA is the only isotretinoin that can be taken without regard to meals due to its unique formulation, which incorporates lipids. This formulation provides optimal absorption to1,3,4:
- Deliver nearly 83% more isotretinoin than generic treatments in the absence of food1
- Achieve visibly clearer skin within just 5 months1
An open-label, single-dose, randomized, 4-treatment, crossover, comparative, bioavailability study was conducted to compare the pharmacokinetic profile of ABSORICA (isotretinoin-LP, test formulation) and standard isotretinoin (reference formulation). Pharmacokinetic parameters included AUCt, AUCi, Cmax, and Tmax.
Of the 60 enrolled patients, 57 completed the 4 treatments, which included a 21-day washout between treatments. Individuals were randomly assigned to 1 of 4 predetermined computer randomization schemes. ABSORICA (isotretinoin-LP) 40 mg and Accutane™ (standard isotretinoin) 40 mg were administered under fed and fasted conditions. Fasted conditions consisted of an overnight fast of at least 10 hours.
Less than 5 months
ABSORICA gives patients the possibility to achieve visibly clearer skin with fewer relapses and retreatments after one treatment cycle.1,7
- In an open-label study, 95% of patients did not need to be treated with isotretinoin during the 2-year post-treatment observation period1,7
- 83% of patients did not need retreatment with any acne medication, over-the-counter or prescription, during the same observation period1,7
A single-arm, open-label study of ABSORICA was conducted to investigate the treatment efficacy, frequency of relapse once the treatment had been discontinued, and quality of life during the active treatment and during a 2-year post-treatment period. The study consisted of 2 phases: a 20-week (5-month) open-label Active Treatment Period (ATP) and a 104-week (2-year) post-treatment period (PTP). The total study duration was 124 weeks, excluding a screening period. During the ATP, after week 2 visit, visits were scheduled at 4-week intervals for a total of 8 visits. During the PTP, the first visit was 4 weeks after End of Treatment (EOT), the second visit was 12 weeks after EOT, and subsequent visits scheduled at 26-week (2 week) intervals for a total of 6 visits. Of the 200 enrolled patients, 119 patients completed the post-treatment period. Approximately 95%, or 113 patients, did not require retreatment with isotretinoin. In addition, 99 patients (approximately 83%) did not need retreatment with any acne medication during this period.7
If your patients are skipping meals while taking a generic isotretinoin because of their busy lifestyles, they may require multiple treatment cycles of isotretinoin due to poor absorption.8
With ABSORICA, patients don't have to change their usual eating style and they don't have to schedule meals so that they match the time they take their medication.1
- ABSORICA is the only isotretinoin with 6 dosage strengths. It is available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg strengths to help your patients get the appropriate amount of isotretinoin based on their weight1
- ABSORICA should be administered in two divided doses of 0.5 to 1 mg/kg per day without regard to meals for 15 to 20 weeks1
You are encouraged to report all side effects or Adverse Drug Events (ADEs) of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. You are also encouraged to report side effects or ADEs to our Drug Safety Department at 1‑800‑406‑7984 or drug.safetyUSA@sunpharma.com (preferred) with as much information as available.