Stiefel Announces FDA Approval of Veltin Gel as Acne Treatment

Stiefel, a GSK company, recently announced the FDA approval of Veltin Gel for the topical treatment of acne vulgaris in patients 12 years and older. According to Stiefel, the medicine is expected to be available by prescription later this year. “Stiefel is bringing another option to physicians and patients to treat acne,” said Bill Humphries, president, Stiefel in a press release. “Now with a retinoid and antibiotic combination added to our portfolio, we offer a broader range of treatment options for acne.” The combination of a topical retinoid and an antibiotic are often recommended for the treatment of acne vulgaris.1 Veltin Gel brings two drug classes — a topical retinoid and an antibiotic — together into a water-based gel with a fixed combination of two solubilized active ingredients: tretinoin and clindamycin phosphate. In a clinical trial including 1,649 patients, Veltin Gel was significantly more effective in the percentage of patients who achieved a 2 grade improvement compared with tretinoin gel, clindamycin gel, and vehicle gel. Veltin Gel also was significantly more effective in the percentage of patients who achieved either clear or almost clear skin as well as a 2 grade improvement compared with tretinoin gel, clindamycin gel, and vehicle gel. In addition, according to the company, Veltin Gel was significantly more effective than tretinoin gel, clindamycin gel, and vehicle gel at reducing the total number of acne lesions; was significantly more effective than tretinoin gel and vehicle gel at reducing the number of inflammatory acne lesions; and was significantly more effective than clindamycin gel and vehicle gel at reducing the number of non-inflammatory acne lesions at 12 weeks. Veltin Gel was not more effective than clindamycin gel at reducing the number of inflammatory acne lesions and was not more effective than tretinoin gel at reducing the number of non-inflammatory acne lesions at 12 weeks. According to company materials, Veltin Gel should not be used by patients who have Crohn's disease, have ulcerative colitis or have developed colitis with past antibiotic use, since clindamycin can cause severe colitis that may result in death. When using Veltin Gel patients should avoid exposure to sunlight, sun lamps and weather extremes and should wear sunscreen daily. Vetin Gel should not be used in combination with erythromycin containing products. In clinical trials, observed local treatment related adverse reactions were application site reactions, including dryness, irritation, exfoliation, erythema, pruritus, and dermatitis. Sunburn was also reported.