FDA Approvals: Ziana, Kadian, Polyphenon E

Yael Waknine

December 01, 2006

December 1, 2006 — The US Food and Drug Administration (FDA) has approved clindamycin phosphate/tretinoin 1.2%/0.025% gel for the once-daily topical treatment of acne vulgaris in patients aged 12 years and older, an 80-mg dose strength for morphine sulfate extended-release capsules to manage moderate to severe pain in opioid-tolerant patients who require continuous opioid therapy for an extended period of time, and an herbal topical ointment for the treatment of external genital and perianal warts caused by certain strains of human papillomavirus.


Clindamycin Phosphate Plus Tretinoin 1.2%/0.025% Gel (Ziana) for Acne

On November 7, the FDA approved clindamycin phosphate 1.2% plus tretinoin 0.025% gel in 30- and 60-g tubes (Ziana, made by Medicis Pharmaceutical Corp) for the once-daily topical treatment of acne vulgaris in patients aged 12 years and older.

The approval was based on data from three 12-week, prospective, multicenter, randomized clinical studies. In studies 1 and 2 (n = 2540), patients were randomized to receive the combination study gel, clindamycin or tretinoin alone in the vehicle gel, or the vehicle gel alone. Results showed that the combination gel was more effective than clindamycin or tretinoin alone for achieving clear or almost clear status (21% vs 16% and 14%, vehicle alone: 8%).

Clindamycin/tretinoin gel was likewise more effective in reducing inflammatory lesion counts (48% vs 42% and 39%, vehicle alone: 26%) and noninflammatory lesion counts from baseline (36% vs 27% and 31%, placebo: 16%).

The third study (n = 2010) further confirmed the improved efficacy of clindamycin/tretinoin gel over clindamycin gel for achieving clear/almost clear status (41% vs 34%) and decreasing inflammatory (61% vs 55%) and noninflammatory lesion counts from baseline (50% vs 41%).

The most commonly reported adverse events in clinical trials included nasopharyngitis (4%), pharyngolaryngeal pain (2%), dry skin (1%), cough (1%), and sinusitis (1%).

The FDA warns that use of the gel is contraindicated in patients with regional enteritis, ulcerative colitis, or a history of antibiotic-associated colitis. Topical use of the product has been shown to result in systemic absorption of clindamycin, leading to diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis). Treatment should be discontinued if significant diarrhea occurs.

The gel also should not be used in conjunction with erythromycin-containing products due to the potential for antagonism between the antimicrobials observed during in vitro studies. The FDA notes that the clinical significance of the interactions is not known.

Also, exposure to sunlight, including sunlamps, should be avoided during clindamycin/tretinoin gel therapy. Patients with sunburn should be advised to avoid using the product pending full recovery due to tretinoin-related susceptibility to sunlight. Daily use of sunscreen products and protective apparel such as hats is recommended.

According to a company news release, the product is expected to be available for shipping to wholesalers in the fourth quarter of 2006.


Morphine Sulfate 80-mg Extended-Release Capsules (Kadian) for Chronic Pain

On October 27, the FDA approved an 80-mg formulation for morphine sulfate extended-release capsules (Kadian, made by Alpharma Pharmaceuticals, Inc).

The capsules were previously approved in 20-, 30-, 50-, 60-, and 100-mg strengths. According to a company news release, addition of the 80-mg formulation is intended to facilitate individualized pain therapy. Its launch on the US market is expected during the fourth quarter of 2006.

Morphine sulfate extended-release capsules are indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Although the capsules should not generally be used during the immediate postoperative period (12-24 hours after surgery), they may be administered in settings of prior (preoperative) use or if the pain is expected to be moderate or severe and persist for an extended period of time.


Herbal Ointment (Polyphenon E, 15%) for Treatment of HPV-Related Genital and Perianal Warts

The FDA approved in October an herbal topical product (Polyphenon E, 15% ointment, made by MediGene AG and marketed by Bradley Pharmaceuticals, Inc) for the treatment of external genital and perianal warts caused by certain strains of human papillomavirus (HPV).

According to a company news release, the active ingredient in the product is a defined mixture of catechins extracted from green tea leaves that acts as an immodulator and also inhibits major functions of the virus. In phase 3 clinical trials (n ≥ 1000 participants in 15 countries), the product demonstrated high and sustained efficacy in the treatment of external genital and perianal warts caused by certain strains of HPV.

Currently approved therapeutic alternatives include cryosurgery and topical imiquimod (Aldara, made by 3M Pharmaceuticals, Inc).

The herbal topical product is expected to be available in the United States during the second half of 2007. The company has also submitted an application for marketing authorization to the European Commission.

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