Evaluating the Efficacy and Safety of Once-Daily Anti-Inflammatory Dose Doxycycline for the Treatment of Rosacea
- Category: Small Molecules
- Published on Tuesday, 01 May 2007 04:00
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NEWTOWN, PA. USA | Apr 30, 2007 | CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced that a new report in the May 2007 issue of the Journal of the American Academy of Dermatology evaluating two randomized phase III clinical trials, demonstrated the efficacy and safety of anti-inflammatory dose doxycycline (Oracea(R), 40-mg doxycycline, USP capsules) for the treatment of rosacea. This report has concluded these studies establish the first important body of evidence supporting the use of a systemic therapy for rosacea that is devoid of antibiotic activity.
The study further concludes that “the antibacterial effects of doxycycline or other antibiotics have not been shown to be of therapeutic importance in rosacea, therefore an effective and safe formulation of this drug that does not exhibit antibiotic selection pressure is clinically significant.”
Lead clinical investigator in these clinical trials, James Q. Del Rosso. DO, Department of Dermatology, University of Nevada School of Medicine, states, “This discussion of the significance of these phase III studies is of utmost importance to the way in which rosacea patients are treated going forward. The option of an effective systemic treatment for rosacea that is devoid of antibiotic activity helps dermatologists reduce their use of antibiotics. Antibiotic use correlates with a rise in bacterial resistance, a problem of global concern.” Anti-inflammatory dose doxycycline was proven to be safe in both studies. The frequency of adverse events was similar to those of patients taking placebo. Of significant note was the finding that in both studies vaginal candidiasis and photosensitivity were not observed in the patients treated with anti-inflammatory dose doxycycline.
Also noteworthy was the fact that once daily dosing, based on a review of several studies, appears to be the dosing regimen associated with the highest rate of patient compliance. Since it is commonly known that an inverse relationship exists between compliance and dosing frequency, this finding holds significant promise for successful treatment of the papulopustular form of rosacea targeted for treatment by anti- inflammatory dose doxycycline.
The study concludes that “anti-inflammatory dose doxycycline is the only tetracycline agent proven to be effective for the treatment of rosacea in pivotal phase III clinical trials and exhibits a pharmacokinetic profile that separates the anti-inflammatory effects from antibiotic activities.”
“The advent of this systemic treatment for rosacea portends a greater population of patients who experience satisfaction from the regimen recommended by their physician because the therapy is easy to comply with and avoids the consequences of antibiotic exposure for a disease where it has not been shown that an antibiotic effect is needed,” said Dr. Del Rosso.
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on developing and marketing proprietary, innovative medical therapies to the dermatology market. In July 2006, CollaGenex launched Oracea(R), the first FDA-approved systemic product for the treatment of rosacea. CollaGenex’s professional dermatology sales force also markets Pandel(R), a prescription topical corticosteroid licensed from Altana, Inc., Alcortin(R) (1% iodoquinol and 2% hydrocortisone), a prescription topical antifungal steroid combination, and Novacort(R) (2% hydrocortisone acetate and 1% pramoxine HCl), a prescription topical steroid and anesthetic. Alcortin and Novacort are marketed by the Company under a Promotion and Cooperation agreement with Primus Pharmaceuticals, Inc. CollaGenex is conducting a 400-patient, Phase II dose-finding study to evaluate its second dermatology candidate, incyclinide, for the treatment of acne. CollaGenex is also conducting Phase I clinical trials to evaluate COL-118, a topical compound based on the SansRosa technology, for the treatment of redness associated with rosacea and other skin disorders.
Research has shown that compounds can be created by chemically modifying certain tetracyclines and that these new compounds have properties that may make them effective in treating diseases involving inflammation and/or destruction of the body's connective tissues. CollaGenex is evaluating various chemically modified tetracyclines (so called “IMPACS” compounds because they are Inhibitors of Multiple Proteases And CytokineS”) to assess whether they are safe and effective in these applications. The Company has a pipeline of innovative product candidates with possible applications in dermatology and other disease states. In addition, CollaGenex has acquired the SansRosa(TM) technology, which consists of a class of compounds that have shown promise in reducing the redness associated with rosacea, and the Restoraderm(R) technology, a unique, proprietary dermal drug delivery system. CollaGenex plans to leverage these platforms to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.
To receive additional information on the Company, please visit our Web site at www.collagenex.com, which does not form part of this press release.
Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company’s plans, timing and success related to its patent applications and the launch of Oracea for the treatment of inflammatory lesions of rosacea, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. CollaGenex' actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in the most recent Form 10-K for the year ended December 31, 2006 under the section "Risk Factors" as well as other documents that may be filed by CollaGenex from time to time with the Securities and Exchange Commission. Forward-looking statements include statements regarding CollaGenex' expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "should", "will", and "would" or similar words. CollaGenex assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: CollaGenex Pharmaceuticals, Inc.