CUMBERLAND, R.I.--(EON: Enhanced Online News)--Onset Dermatologics, a leader in developing and commercializing prescription products for improving skin health, today announced the acquisition of Clindagel® from Galderma Laboratories. Clindagel® is a prescription topical antibiotic for the treatment of acne.
“As a company, we are committed to providing products to help dermatology practitioners improve outcomes in their patients.”
“Onset Dermatologics is pleased to add Clindagel® to our portfolio of acne products,” said Robert Moccia, President, Onset Dermatologics. “As a company, we are committed to providing products to help dermatology practitioners improve outcomes in their patients.”
Clindagel® is the only topical formulation of clindamycin phosphate with once daily dosing approved by the U.S. Food and Drug Administration. In a 12-week multicenter, randomized, blinded, vehicle-controlled clinical trial in which patients used Clindagel® or its vehicle gel in the treatment of acne of mild-to-moderate severity, 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.
"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," says Jerald L. Sklar, MD, of Dallas Associated Dermatologists in Dallas, Texas.
Onset will begin promotion of Clindagel® to dermatologists and their associates in December. Clindagel® 75 ml 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.
Roberts Mitani acted as an advisor to Onset Dermatologics for the transaction.
Important Safety Information for Clindagel® (clindamycin phosphate gel) topical gel, 1% Clindagel® is indicated for topical application in the treatment of acne. Clindagel® is contraindicated in patients with a history of hypersensitivity to clindamycin or lincomycin; or a history of regional enteritis or ulcerative colitis; or a history of antibiotic-associated colitis. Diarrhea, bloody diarrhea, and pseudomembranous colitis have been reported with topical clindamycin. Discontinuation is recommended if diarrhea develops.
About Onset Dermatologics, LLC
Headquartered in New York and Cumberland RI, Onset Dermatologics is a fully-integrated prescription dermatology company with a mission to deliver innovative therapies to dermatologists and their patients. In addition to Clindagel®, Onset Dermatologics markets the prescription brands Locoid®, HylatopicPlus®, Aurstat®, Tretin-X®, Minocin®, and Clarifoam®EF to dermatologists and their allied healthcare providers. Onset is expanding rapidly through internally generated innovation, acquisitions, in-licensing, and co-marketing opportunities. For additional information, visit www.onsetdermatologics.com.