Regulatory Update -- Stiefel, a GSK company announces a new, alternate, fixed-dose combination of Duac® (clindamycin 1% and benzoyl peroxide 3%) gains positive recommendation for approval in Europe
RESEARCH TRIANGLE PARK, North Carolina, March 4, 2013 /PRNewswire/ -- Stiefel, a GSK (LSE:GSK) company, announced today that it has received positive recommendation by MHRA (Medicine and Healthcare products Regulatory Agency, UK) for the approval of a new fixed-dose combination of Duac® (clindamycin 1% and benzoyl peroxide 3%) gel for the topical treatment of mild to moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and older.(1) This new fixed-dose combination of Duac is an extension to the parent product Duac (clindamycin 1% and benzoyl peroxide 5%), which is currently approved and available in more than 50 countries around the world including US, Europe, Asia, Australia, Latin America and Canada.
The regulator's recommendation positively concludes the European regulatory procedure and instigates the process of granting national licences to make it available in 15 European countries.
This recommendation is based on review of the data on quality, safety and efficacy of this new fixed-dose combination. The safety and efficacy was evaluated in a phase III study of 1319 patients with mild to moderate acne. The study compared the new fixed-dose combination to each of the individual components (clindamycin 1% or benzoyl peroxide 3% or vehicle) applied once daily for 12 weeks.(2)
About Acne Vulgaris
Acne vulgaris is the most common skin disease. It is most commonly seen during the teenage years but can affect males and females of any age.(3) Acne lesions may be non-inflamed, appearing as whiteheads or blackheads, or inflamed, developing as papules, pustules or nodules, and may be described as mild, moderate or severe, depending on the types, numbers and locations of lesions.(4,5) There is no single risk factor for developing acne; hormones, genetics and environmental factors all affect the physiology of the skin in unique ways for each person.(6) Because acne is a very visible condition, it may have a significant psychosocial impact on patients.(7)
About Duac (clindamycin 1% and benzoyl peroxide 3%)
This new fixed-dose combination of Duac contains two medicines: clindamycin 1% and benzoyl peroxide 3% in a gel base formulation. The positive recommendation for approval allows the 15 European countries to issue licences and make the product available for the topical treatment of mild to moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and older. Efficacy and safety have not been established in children under 12 years of age and therefore the product is not recommended for use in this population.
The product is contraindicated in patients who have demonstrated hypersensitivity to any of the ingredients and in patients with, or with a history of, regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis).
Contact with the mouth, eyes, lips, and other mucuous membranes or areas of irritated or broken skin should be avoided. Application to sensitive areas of skin should be made with caution. In case of accidental contact, rinse well with water.
The product should be used with caution in atopic patients, in whom further skin drying may occur.
During the first weeks of treatment, benzoyl peroxide-containing products can cause an increase in peeling and reddening in most patients. Depending on the severity of these side effects, patients can use a non-comedogenic moisturiser, temporarily reduce the frequency of application or temporarily discontinue use; however, efficacy has not been established for less than once daily dosing frequencies.
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.
If severe local irritancy (e.g., severe erythema, severe dryness and itching, severe stinging/burning) occurs, treatment should be discontinued.
As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.
If a patient has sunburn, this should be resolved before use the product.
If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment should be discontinued immediately, as the symptoms may indicate antibiotic-associated colitis. Suitable diagnostic methods, such as the determination of Clostridium difficile and toxin and, if necessary, colonoscopy should be employed and treatment options for colitis considered.
The product may bleach hair and coloured or dyed fabrics. Avoid contact with hair, fabrics, furniture or carpeting.
Patients with a recent history of systemic or topical clindamycin or erythromycin use are more likely to have pre-existing and anti-microbial resistant Propionibacterium acnes and commensal flora.
Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy.
This new fixed-dose combination of Duac (clindamycin 1% and benzoyl peroxide 3%) was first approved in Canada in April 2012. It is not approved or licensed in the US and may not be approved in other parts of the world for the topical treatment of mild to moderate acne vulgaris. The EU Summary of Product Characteristics will be published on the EMA website, together with the European Public Assessment Report (EPAR, http://www.ema.europa.eu) and in the Community Register of Medicinal Products on the European Commission's website (http://ec.europa.eu/health/documents/community-register/html/index_en.htm).
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.
Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. 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 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.
References:
- EU Summary of Product Characteristics
- Eichenfield LF. "Safety and Efficacy of Clindamycin Phosphate 1.2% – Benzoyl Peroxide 3% Fixed-Dose Combination Gel for the Treatment of Acne Vulgaris: A Phase 3, Multicenter, Randomized, Double-Blind, Active- and Vehicle-Controlled Study." J Drugs Derm. December 2011; Vol. 10: 1382-1396
- Ferri F. Acne Vulgaris. In: Ferri, 1st ed. Ferri's Clinical Advisor Philadelphia, Pennsylvania: Mosby;2012:23-24
- Ferri F. Acne Vulgaris. In: Ferri, 1st ed. Ferri's Clinical Advisor Philadelphia, Pennsylvania: Mosby;2012:23-24
- Habif T. Acne, Rosacea, and Related Disorders. In: Habif, 5th ed. Clinical Dermatology. Philadelphia, Pennsylvania:Mosby;2009:217-239
- Yan AC. "Current Concepts in Acne Management." Adolesc. Med. 2006; Vol. 17:613-637.
- Ferri F. Acne Vulgaris. In: Ferri, 1st ed. Ferri's Clinical Advisor Philadelphia, Pennsylvania: Mosby;2012:23-24
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