7 February 2020 - - A subsidiary of Indian drugmaker Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO) (NSE: SUNPHARMA, BSE) wholly owned subsidiaries has launched Absorica LD (isotretinoin) capsules in US for the management of severe recalcitrant nodular acne in patients 12 years of age and older, the company said.

Absorica LD is the only isotretinoin formulation to feature Sun Pharma's micronization technology, which utilises micronised particles to optimise absorption at a 20% lower dose. Absorica LD can be taken with or without food.

Relapse and retreatment rates for severe recalcitrant nodular acne are associated with insufficient absorption of isotretinoin.

In a recent Phase IV open-label study evaluating the long-term efficacy and safety of Absorica in 166 patients, a single 20-week course of therapy resulted in complete and prolonged remission of severe recalcitrant nodular acne.

After one 20-week course of Absorica therapy, 95% of patients didn't require additional isotretinoin treatment and 82% of patients didn't require any additional acne treatment (OTC or prescription) up to two years post-treatment.

Absorica and Absorica LD can cause severe life-threatening birth defects and are contraindicated in pregnancy.

There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking any amount of Absorica or Absorica LD even for short periods of time.

Because of the risk of embryo-fetal toxicity, Absorica and Absorica LD are available only through a restricted programme under a Risk Evaluation and Mitigation Strategy called the iPLEDGE REMS.

Absorica LD 32 mg is bioequivalent to Absorica 40 mg under fed conditions.

Absorica LD also delivers twice the level of absorption of Absorica in a fasted state, with a comparable safety profile. Absorica LD provides maximal isotretinoin absorption with a 20% lower dose, and is not substitutable with any other currently available isotretinoin.

The most common adverse reactions (incidence ≥ 5%) with Absorica LD or Absorica 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, and reduced visual acuity.

Absorica and Absorica LD (isotretinoin) capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater.

Because of significant adverse reactions associated with their use, Absorica and Absorica LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.

Sun Dermatology (the branded dermatology division of a wholly owned subsidiary of Sun Pharmaceutical Industries Inc.) is committed to expanding its dermatology portfolio to bring healthcare providers and patients around the world more treatment options and ongoing support for conditions like moderate-to-severe plaque psoriasis.

Sun Pharmaceutical Industries Ltd., along with its subsidiaries, is ranked second in dermatology prescription volume within the US per IQVIA and is the fourth largest specialty generic pharmaceutical company globally.

In addition to Absorica LD, Sun Dermatology is comprised of several branded products with a focus on various dermatologic conditions.

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices.

Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities.

Sun Pharma fosters excellence through innovation supported by strong R and D capabilities across multiple R and D centers, with investments of approximately 7% of annual revenues in R and D.