You are here

FDA Approves Clindamycin Foam for Treating Acne

PALO ALTO, Calif., Oct. 25 /PRNewswire-FirstCall/ -- Connetics Corporation (Nasdaq: CNCT), a specialty pharmaceutical company that develops and commercializes dermatology products, today announced that the U.S. Food and Drug Administration (FDA) has approved Evoclin (clindamycin) Foam, 1% for the treatment of acne vulgaris. Evoclin (formerly referred to as Actiza(TM)) is the first product approval for Connetics that is intended to address the acne market. Evoclin is delivered in Connetics' proprietary VersaFoam(R) vehicle and will be available in the fourth quarter of 2004 in 50g and 100g trade unit sizes.

"Clindamycin is the most popular topical antibiotic used for treating acne patients and represents approximately one-third of the topical acne market," said Alan Shalita, M.D., an Evoclin clinical study investigator and Distinguished Teaching Professor and Chairman of the Department of Dermatology SUNY Downstate Medical Center. "The novel VersaFoam formulation of clindamycin has the added advantage of being a once-a-day therapy that leaves minimal residue, dissolves rapidly upon contact with skin and is easy to apply. The approval of Evoclin provides a new and valuable option to dermatologists in treating patients who suffer from acne."

The topical prescription acne category is one of the largest segments in the U.S. dermatology market, and is estimated to exceed $1.2 billion annually. Approximately 17 million people in the U.S. have acne resulting in approximately 5.5 million office visits per year.

"This is a very important approval for Connetics. Evoclin is our fourth commercial brand and our first product in the acne market. The approval of Evoclin further defines the quality and consistency of our product development activities and sets the stage for continued growth," said Thomas G. Wiggans, Connetics' Chief Executive Officer. "Every stage of the development and regulatory process was well executed by the Connetics team. The commercial launch of Evoclin and our ongoing sales force expansion coupled with Connetics' commercial and pipeline activities bodes well for a very exciting finish to 2004."

Evoclin is indicated for topical application in the treatment of acne vulgaris. Evoclin is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Source: Connetics, Inc.

Recent Headlines

Disrupting Gut Microbiome Could Be Key
Drug Boosts Levels of Natural Endocannabinoids
Judicious Use of Antibiotics May Not Be Enough To Defeat Bacteria That Carry On By Going Into a Dormant State
KRAS Oncogene Is a Problematic Target So Researchers Are Trying Workdarounds
Understanding Neural Ensembles in Infralimbic Cortex May Lead To Improved Addiction Treatment
Vitamin E Found in Samples Around the Country
Study Links Them to Premature Death
Nag With Texting and a ‘Winners Circle’
How Serotonin and Fluoxetine Affect Microbiota Residing in the Gut