May 3 2007, 8:00 AM EST
MARKETWIRE
Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company that develops and markets dermatology products, today announced that the U.S. Food and Drug Administration (FDA) approved the company's application to add clinical data to the prescribing information for Solage(R) (mequinol 2%, tretinoin 0.01%) Topical Solution. The newly added information shows that Solage treatment for solar lentigines (age spots) is safe and effective in patients with darker skin types.
The new prescribing information includes data from a Phase 4 post-approval study that demonstrated favorable results on the efficacy, safety and tolerability of Solage for the treatment of solar lentigines in patients with darker skin types. Study findings on the safety and tolerability of Solage in darker phototypes demonstrated a favorable benefit-to-risk ratio in the treatment of solar lentigines in African American, Asian and Latin/Hispanic patients. Over 80% of treated patients in this study achieved a significant response to therapy for facial and arm lesions. Additionally, the majority of subjects maintained clinical benefit during a 4-week post treatment period. These results are consistent with efficacy findings previously reported for Caucasian individuals.
About Solage
Barrier Therapeutics currently markets Solage(R) (mequinol 2%, tretinoin 0.01%) Topical Solution in the United States where it is indicated for the treatment of solar lentigines and also markets the product in Canada where the indication includes use for related hyperpigmented lesions. Solage Topical Solution is currently the only combination product approved for the treatment of solar lentigines. More importantly, Solage Topical Solution has been approved as a safe and effective treatment of solar lentigines as part of a comprehensive skin care and sun avoidance program. Solage Topical Solution is the only FDA approved combination skin lightening agent that does not contain hydroquinone.
About Barrier Therapeutics
Barrier Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of products in the field of dermatology. Barrier Therapeutics currently markets three pharmaceutical products in the United States: Xolegel(TM) (ketoconazole, USP) Gel, 2%, for seborrheic dermatitis; Vusion(TM) (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment, for diaper dermatitis complicated by documented candidiasis; and Solage(R) (mequinol 2.0%, tretinoin 0.01%) Topical Solution, for solar lentigines. Barrier Therapeutics has other product candidates in various stages of clinical development for the treatment of a range of dermatological conditions, including onychomycosis, psoriasis, acne, skin allergies, and acute fungal infections. The company is headquartered in Princeton, New Jersey and has wholly owned subsidiaries in Geel, Belgium and Ontario, Canada. More information about Barrier Therapeutics can be found on its corporate website at: www.barriertherapeutics.com.
Xolegel, Vusion and Solage are trademarks of Barrier Therapeutics, Inc.
Safe Harbor Statement
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Barrier's current expectations or forecasts of future events. Barrier's performance and financial results could differ materially from those reflected in these forward-looking statements due to the marketplace acceptance of Barrier's products, Barrier's ability
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