FDA Approves Veltin

Stiefel, a GSK company, Receives FDA Approval of Veltin (clindamycin phosphate and tretinoin) Gel 1.2%/0.025%

Research Triangle Park, N.C. – July 16, 2010 – Stiefel, a GSK company, today announced that the U.S. Food and Drug Administration (FDA) has approved Veltin Gel 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.

"Stiefel is bringing another option to physicians and patients to treat acne," said Bill Humphries, president, Stiefel. "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.[i] Veltin Gel brings these two drug classes together into a water-based gel with a fixed combination of two solubilized active ingredients:tretinoin and clindamycin phosphate.

"Veltin Gel gives patients and physicians two medicines in one product," said Guy Webster, M.D., a clinical trial investigator and consultant for Stiefel. "When measuring treatment success in a clinical study, Veltin Gel performed better than tretinoin gel or clindamycin gel alone."(In this clinical trial, treatment success was defined as a minimum of a two-grade improvement in investigator static global assessment.)

In the 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, 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.

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. Veltin 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.

About Veltin Gel

Veltin Gel is a combination of tretinoin and clindamycin phosphate. It is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Veltin Gel should be applied once daily in the evening to the affected area. For further information, including complete Prescribing Information, please call 919-483-2839.

About Stiefel, a GSK company

Stiefel, a GSK company, is committed to advancing dermatology and skin science around the world in order to help people better achieve healthier skin. Stiefel’s dedication to innovation, along with its focus on pharmaceutical, over-the-counter and aesthetic dermatology products, has established Stiefel as a world leader in the skin health industry. To learn more about Stiefel, visit www.stiefel.com.

GlaxoSmithKline cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the ‘Business Review’ in GSK's Annual Report on Form 20-F for 2009.

References

[i] Gollnick H, Cunliffe W, Berson D, Dreno B, Finlay A, Leyden JJ, et al. Management of Acne: a report from a global alliance to improve outcomes in acne. J Am Acad Dermatol 2003; 49 (suppl): s1-38.

Posted: July 2010

Related Articles:

Veltin (clindamycin and tretinoin) FDA Approval History

View comments

Hide
(web3)