New Drug Introduced

Posted on: Tue, 07/25/2006 - 13:33 By: nrs-admin

The following announcement was issued by CollaGenex Pharmaceuticals:


(doxycycline, USP) capsules 40 mg*
* 30 mg immediate release and 10 mg delayed release beads

July 13, 2006 — Newtown, PA — CollaGenex Pharmaceuticals (Nasdaq: CGPI) launches Oracea, a breakthrough new treatment for rosacea patients. Oracea (Or-RAY-sha) is the first orally administered, systemically delivered drug available to rosacea patients that has received approval from the U.S. Food and Drug Administration.

Approximately 14 million American women and men suffer from rosacea, a highly visible and difficult to conceal skin condition. In addition to the burden of coping with this disease, many also face the emotional burden that frequently accompanies it.

What Makes Oracea Different?
Oracea provides an important series of firsts in the treatment of the papules and pustules (pimples and red bumps) of rosacea. Oracea is the:

  • First FDA-approved oral treatment
  • First effective oral alternative to the systemic antibiotics traditionally used to treat rosacea; Oracea offers anti-inflammatory action without demonstrated antimicrobial effects
  • First oral treatment with established long-term safety; Oracea was used daily for up to 9 months in clinical trials.
  • First oral treatment with a side effect profile similar to placebo; photosensitivity and vaginal candidiasis were not seen in clinical trials.


Making Life Easier for Rosacea Patients:
“Many of the tolerability and safety concerns associated with traditional systemic antibiotic therapy are not an issue with Oracea,” explained Klaus Theobold, M.D. Ph.D, Chief Medical Officer for CollaGenex. “High dose oral antibiotics, although not approved by FDA for rosacea, are frequently used for this purpose. They have been associated with some unpleasant side effects such as gastrointestinal upset, vaginal yeast infections and photosensitivity, which may require discontinuation of treatment. In clinical trials with Oracea, the incidence of these side effects was comparable to placebo. In addition, Oracea does not change the bacterial resistance profile because it has no detectable effect on the bacterial flora of treated patients. Bacterial resistance is a major public health concern.” The once-a-day dosing of Oracea also makes it easier for a rosacea sufferer to be compliant with the therapy.

A New Way of Treating a Complex Skin Disease
Oracea represents a significant advance in the treatment of rosacea. According to the lead investigator for the clinical trials of the drug, James Q. Del Rosso, D.O., Clinical Associate Professor, Department of Dermatology, University of Nevada School of Medicine, Las Vegas, Nevada, “Oracea provides therapeutic efficacy in rosacea through anti-inflammatory effects and is devoid of antibiotic activity. Therefore, even with long-term use, development of antibiotic resistance is not an issue. Many rosacea patients will benefit from a once-daily formulation of doxycycline that has been optimized to treat rosacea effectively and safely.”

Clinical Trials Confirm the Efficacy of Oracea
Oracea has been studied extensively in clinical trials. In two double-blinded, placebo-controlled Phase 3 clinical studies, patients were administered either Oracea or placebo once a day for 16 weeks. A total of 537 patients were enrolled in 28 centers across the U.S. Both studies achieved their primary endpoint by demonstrating a greater reduction in inflammatory lesion count from baseline for the Oracea-treated patients compared to the placebo controls. In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20%, respectively, in patients receiving placebo. The differences were clinically and statistically highly significant (p<0.001 in each study).

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