To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Zindaclin (Clindamycin/Zinc) Gel for Acne Launched in United Kingdom URL: http://www.pslgroup.com/dg/214F4E.htm Doctor's Guide March 22, 2002
DALLAS, TX -- March 22, 2002 -- Access Pharmaceuticals, Inc. today announced that Strakan, Ltd., the worldwide licensee of its ResiDerm® technology, has launched Zindaclin™ on the United Kingdom market.
Also, the process to achieve marketing authorization throughout Europe has been initiated and the first country approvals are expected by the end of 2002.
The United Kingdom Medicines Control Agency approved Zindaclin for once-a-day application for the treatment of acne. Zindaclin is a clindamycin zinc complex in a gel formulation with a prolonged residence in the skin, providing a sustained release effect, which reduces absorption of the drug into the systemic circulation and the associated side effects. Clinical studies confirmed that once-daily dosing was equivalent to the market-leading clindamycin product, which requires twice per day application.
The advantages of Zindaclin over competitive products include: convenient once-daily application (ability to apply last thing in the evening); cosmetically acceptable formulation; stable gel formulation which does not require reconstitution before dispensing; reduced systemic drug exposure.
Zinc, which is a component of the formulation to maintain drug concentration in the skin, is also an anti-microbial which reduces acne bacteria and may help to minimize the number of patients that become resistant to the antibiotic. The once-daily usage could also reduce skin irritation which is a common long-term problem for acne suffers.
Zindaclin is advancing in the United States where additional clinical data is required prior to filing a New Drug Application with the Food and Drug Administration.
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