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news.Stiefel, a GlaxoSmithKline company, has received approval from FDA for Veltin gel (clindamycin phosphate and tretinoin) 1.2%/0.025% for the topical treatment of acne vulgaris in patients 12 years and older. Stiefel expects to make the medicine available by prescription later this year.
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Stiefel said that the combination of a topical retinoid and an antibiotic are often recommended for the treatment of acne vulgaris. Veltin gel brings these two drug classes together into a water-based gel with a fixed combination of two solubilised active ingredients:tretinoin and clindamycin phosphate.
Stiefel’s Veltin gel clinical trial was shown to be more effective in the percentage of patients who achieved a 2 grade improvement compared with tretinoin gel, clindamycin gel, and vehicle gel.
Additionally, Veltin gel also demonstrated to be 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.
Stiefel said that Veltin gel was more effective than tretinoin gel, clindamycin gel, and vehicle gel at reducing the total number of acne lesions; was more effective than tretinoin gel and vehicle gel at reducing the number of inflammatory acne lesions; and was more effective than clindamycin gel and vehicle gel at reducing the number of non-inflammatory acne lesions at 12 weeks.
Bill Humphries, president of Stiefel, said: “Now with a retinoid and antibiotic combination added to our portfolio, we offer options for acne.”
Guy Webster, clinical trial investigator and consultant for Stiefel, said: “Veltin gel gives patients and physicians two medicines in one product. When measuring treatment success in a clinical study, Veltin gel performed better than tretinoin gel or clindamycin gel alone.”