Glenmark to launch adapalene gel to treat a severe form of acne in US

Indian generics firm Glenmark is planning to launch its adapalene gel treatment for a severe form of acne in US.

Adapalene gel is indicated for the topical treatment of acne vulgaris.

Acne vulgaris is the common form of acne seen most often in teenagers or young adults. Acne vulgaris is the result of overactive oil glands that become plugged, red, and inflamed.

Most outbreaks of acne can be treated by keeping the skin clear and avoiding irritating soaps, foods, drinks, and cosmetics. Severe acne and acne in those who are prone to scarring can be treated with topical creams and anti-inflammatory medications.

Skin damaged by acne can be improved with treatment by a dermatologist or facial technologist. Techniques include dermabrasion (sanding), removal of scar tissue via laser, and chemical peels. Acne is also called pimples.

The key factor contributing to acne is genetics. If both parents had acne, 3 of 4 children will have acne. If 1 parent had acne, then 1 of 4 of the children will have acne.

Sebum production and excretion are regulated by a number of different hormones and mediators. In particular, sex hormones promote sebum production and release.

Acne is common in North American whites. Spanish persons tend to more commonly develop cystic acne. African Americans have a higher prevalence of pomade acne, likely stemming from the use of hair pomades.

During adolescence, acne vulgaris is more common in males than in females. In adulthood, acne vulgaris is more common in women than in men.

Acne vulgaris may be present in the first few weeks and months of life, when a newborn is still under the influence of maternal hormones and when the androgen-producing portion of the adrenal gland is disproportionately large. This neonatal acne tends to resolve spontaneously. However, the neonate should be treated with a mild retinoid to clear out the impacted follicles.

Adolescent acne usually begins with the onset of puberty, when the gonads begin to produce and release more androgen hormone.

Acne is not limited to adolescence. Twelve percent of women and 5% of men at age 25 years have acne. By age 45 years, 5% of both men and women still have acne.

Glenmark’s adapalene gel product is the AB rated generic equivalent of Galderma’s Differin gel which generated approximately USD 84 million in sales for the 12 month period ending March 2010, according to IMS Health.

Glenmark Generics Inc, USA (GGI), a subsidiary of Glenmark Generics Limited (GGL), has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (US FDA) for adapalene gel, 0.1% and will soon commence marketing and distribution of this product in the US market, the company said in a press statement.

With the adapalene approval, Glenmark will now have a total of 15 semi-solid products authorized for distribution in US market.

Glenmark currently sells 55 products in the US marketplace. The company is also awaiting approvals for dozens of more ANDAs pending with the US FDA.

In April, Glenmark was granted approval for generic contraceptive pill norethindrone tablets 0.35mg by the United States Food and Drug Administration (US FDA).

Glenmark’s norethindrone tablets 0.35mg is the generic version of Nor-QD.

Norethindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy.

Glenmark will be market norethindrone pills under the trade name Heather and distribution is expected to start immediately, the company said in a press release.