1st Generation
Requires5-8
- High-fat meal for optimal absorption
- Liver test
Based on meal requirements in Webster, et al. 2013.5
2nd Generation
Lipid coating lessens meal requirement5
3rd Generation
2 Innovations1,9,10
THE LD DIFFERENCE
Long-lasting clearance
2-years post treatment1,2*†
95%
required NO retreatment with isotretinoin1,2*†
82%
required NO retreatment with any OTC or prescription acne medication1,2*†
*ABSORICA®/ABSORICA LD Clinical Statement
The effectiveness of ABSORICA/ABSORICA LD for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older has been established and is based on a double-blind, randomized, parallel group trial in subjects with severe recalcitrant nodular acne who received ABSORICA or another isotretinoin capsule product under fed conditions.
ABSORICA LD was approved by the FDA based on ABSORICA clinical data.
†Phase IV trial analyzing efficacy of ABSORICA based on per protocol population N=166; N=119 patients completed the post-treatment period.
DID YOU KNOW?
With first generation isotretinoins, 23% of patients relapse after one treatment cycle3‡
‡In a retrospective study of 405 isotretinoin patients, 94 (23.2%) experienced relapse. Relapse defined as the reappearance of acne severe enough to warrant retreatment.2-4
STUDY DESIGN
A single-arm, open-label study of ABSORICA was conducted to investigate the treatment efficacy, frequency of relapse once treatment has been discontinued, and quality of life during the active treatment and during a 2-year post-treatment period. An initial 20-week, open-label, active-treatment-period (ATP) of lidose-isotretinoin was followed by a 104-week follow-up post-treatment period (PTP), in which endpoints included monitoring of retreatment. The total study duration was 124 weeks, excluding a screening period. During the PTP, the first visit took place at Week 24, followed by visits at weeks 32, 46, 72, 98, and 124. Of the 201 enrolled patients, 166 fit the protocol to start treatment. 4.2%, or 7 patients, required retreatment with isotretinoin. In addition, 82.5%, or 137 patients, did not need retreatment with any acne medication (OTC or prescription) during this period. Efficacy analyses were assessed using the per-protocol population (166). However only 119 patients completed the post-treatment period; those who withdrew or were otherwise lost to follow-up were assumed to not need treatment.2
THE LD DIFFERENCE
Evolution of absorption
ABSORICA LD is a 3rd generation isotretinoin that provides maximal peak plasma concentration regardless of meals1,5*
§Cmax values (ng/mL) in a fasted state expressed as a percentage of Cmax values in a fed state for each product.
Most common adverse reactions (incidence ≥ 5%) are: dry lips, dry skin, back pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, increased creatine kinase, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, reduced visual acuity.
Innovations in Isotretinoin
ABSORICA LD is a 3rd generation isotretinoin that provides maximal peak plasma concentration regardless of meals1,5*
“
You don’t have to eat a high-fat diet with ABSORICA LD. You don’t have to eat a meal at all.”
-Actual
ABSORICA LD
Patient
THE LD DIFFERENCE
Reliable Absorption
Absorption of isotretinoin is critical to reaching a therapeutic dose and lower rates of relapse.2
ABSORICA LD delivers predictable absorption in a fasted state.1,9
Comparative pharmacokinetics of ABSORICA and ABSORICA LD in a fasted state9
Comparative pharmacokinetics of ABSORICA and ABSORICA LD in a fed state9
STUDY DESIGN
Two open-label, crossover studies compared the bioavailability of micronized-isotretinoin 32 mg and lidose-isotretinoin 40 mg in fed and fasted state in healthy adults. ABSORICA LD demonstrated twice the plasma concentrations than ABSORICA in a fasted state. When administered in a fed state, plasma concentrations were bioequivalent between ABSORICA and ABSORICA LD.9
IMPORTANT SAFETY INFORMATION
Because of the risk of embryo-fetal toxicity, ABSORICA LD is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE® REMS.
Please see full Important Safety Information.
Real Patient Results
BEFORE
AFTER
Actual ABSORICA LD patient of
SEE THE LD DIFFERENCE
An ABSORICA LD patient story
Because of the risk of embryo-fetal toxicity, ABSORICA LD is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE® REMS.
Please see full Important Safety Information.
