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Sun Pharma introduces a lower dose isotretinoin capsule in the U.S. for the treatment of severe recalcitrant nodular acne.
Earlier this month, Sun Pharmaceutical Industries Ltd. introduced a lower dose of their isotretinoin capsules (Absorica, Sun Pharma) for the management of severe recalcitrant nodular acne in patients 12 years and older.
The drug is the industry’s first tretinoin capsule (Absorica LD, Sun Pharma) equipped with the company’s micronization technology, which enhances absorption at a 20% lower dose through the use of micronized particles, according to the company press release. Absorica LD 32 mg is bioequivalent to the 40 mg Absorica capsule.
The announcement follows the release of results from the company’s phase 4 study investigating the long-term safety and efficacy of their isotretinoin capsules in 166 participants. Data showed a complete and extended remission of severe recalcitrant nodular acne after a single 20-week treatment course. The majority of patients (95%) didn’t need further isotretinoin treatment and most (82%) didn’t require additional over-the-counter (OTC) or prescription acne treatment for up to two years post-treatment.
The company press release adds that relapse and retreatment rates for severe recalcitrant nodular acne are often due to insufficient absorption of isotretinoin.
“ABSORICA LD makes visibly clearer skin possible within just five months, removes the uncertainty surrounding timing of dosing, and makes absorption more predictable. The availability of a low-dose, highly bioavailable oral isotretinoin option should be welcome news for those suffering from [severe recalcitrant nodular acne],” says Nicholas Squittieri, M.D., chief medical officer of Sun Pharma North America.
Common adverse reactions (incidence ≥ 5%) of isotretinoin include chapped and dry lips, dermatitis, headache, dry eye, cheilitis, nasopharyngitis, dry skin, back pain, arthralgia, epistaxis, increased creatine kinase, musculoskeletal discomfort, reduced visual acuity and upper respiratory tract infection.
Per the press release, both formulations of isotretinoin (Absorica and Absorica LD) from Sun Pharma can cause severe life-threating birth defects with a high risk of occurrence if taken when pregnancy occurs no matter the dose or time period during which the drug is taken.
Additionally, both drugs are only available through restricted Risk Evaluation and Mitigation Strategy (REMS) programs - iPLEDGE REMS - due to the risk of embryo-fetal toxicity.
Sun Pharma Introduces ABSORICA LD™ (Isotretinoin) Capsules for Management of Severe Recalcitrant Nodular Acne in the U.S. Business Wire. https://www.businesswire.com/news/home/20200204005471/en/Sun-Pharma-Introduces-ABSORICA-LD™-Isotretinoin-Capsules. Published February 4, 2020. Accessed February 24, 2020.