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New Drug Application Submitted for Clindamycin Phosphate Foam
PALO ALTO, Calif., Dec. 22 /PRNewswire-FirstCall/ -- Connetics Corporation , a specialty pharmaceutical company that develops and commercializes dermatology products, today announced that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Actiza™, an investigational new drug formulation of 1% clindamycin delivered in the Company's proprietary VersaFoam™ delivery system, as a potential new topical treatment for acne.
In September, Connetics announced positive results from its Phase III clinical trial with Actiza versus Clindagel® for the treatment of acne. Based on pre-NDA discussions, the FDA indicated that this 505(b)(2) application qualifies for exclusion from a user fee assessment.
According to the National Institute of Arthritis, Musculoskeletal and Skin Disorders (NIAMS), an estimated 17 million people in the U.S. are affected by acne, and an estimated 5.1 million people visit a physician for treatment per year. The prescription acne category is the largest segment of the dermatology market, and is estimated to be in excess of $1.5 billion annually in the U.S., not including oral antibiotics. Topical antibiotics, like clindamycin, are a major component of the prescription acne market and represent approximately one third of the market. Clindamycin is one of the most widely prescribed medications for acne.
Source: Connetics Corporation