FAIRFIELD, N.J., Dec. 14 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. (NYSE: BDY) today announced its launch of Veregen(TM) (sinecatechins) Ointment, 15%, indicated for the topical treatment of external genital (EGW) and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Veregen(TM) is the first new prescription treatment for external genital warts in ten years. Bradley licensed the product from MediGene AG (Frankfurt: MDG) and has exclusive marketing rights in the United States.
Veregen(TM) is the first botanical drug approved for prescription use in the United States and is patented through 2017, with additional applications pending which, if approved, would extend patents beyond 2020. The active ingredient in Veregen(TM) is sinecatechins, a proprietary mixture of 8 catechins, the primary phenols found in green tea leaves. The health benefits associated with catechins are attributed in part to their antioxidant properties.
In two Phase III randomized, double-blind, vehicle-controlled studies, Veregen(TM) proved effective in clearing both baseline and newly emerging external genital and perianal warts, with complete clearance in 53.6% of all patients studied who received Veregen(TM) (as compared to 35.3% of those patients receiving vehicle). Veregen(TM) also demonstrated low recurrence rates during these trials. When treated with Veregen(TM), only 6.8% of the patients experienced recurrence. The majority of adverse reactions reported during these studies were mild to moderate skin and application site reactions, and there were no systemic side effects reported.
External genital warts are one of the most common and fastest spreading
venereal diseases worldwide. More than 1
|SOURCE Bradley Pharmaceuticals, Inc.|
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