Onset Dermatologics Acquires Worldwide Rights to Clindagel from Galderma Laboratories

10/31/2013

Onset Dermatologics, LLC recently announced the acquisition of Clindagel(clindamycin phosphate gel 1%), a prescription topical antibiotic for the treatment of acne, from Galderma Laboratories.

Clindagel is the only FDA-approved topical formulation of clindamycin phosphate with once daily dosing. In a 12-week multicenter, randomized, blinded, vehicle-controlled clinical trial in which patients used Clindagel or its vehicle gel in the treatment of mild to moderate acne, Clindagel applied once daily was more effective than the vehicle. The mean percentage reduction in acne inflammatory lesion counts at the end of the study was 51% with Clindagel vs. 40% with the vehicle. In addition, Clindagel was well tolerated and demonstrated side effect profile similar to the water-based placebo gel vehicle alone.

Onset will begin promotion of Clindagel to dermatologists and their associates in December. Clindagel 75ml will continue to be available for order through Galderma Laboratories (NDC 0299-4500-75) until mid-December when the product transition to Onset Dermatologics is complete.

 “Onset Dermatologics is pleased to add Clindagel to our portfolio of acne products,” said Robert Moccia, President, Onset Dermatologics, in a press release. “As a company, we are committed to providing products to help dermatology practitioners improve outcomes in their patients.”

“I am delighted that Onset will be promoting and bringing Clindagel back to my practice. My acne patients have always appreciated the ease of once daily dosing and the pleasant water base vehicle of Clindagel. As dermatologists, we choose to prescribe agents with high patient acceptability for chronic conditions such as acne,” said Jerald L. Sklar, MD, of Dallas Associated Dermatologists in Dallas, TX.

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