Promoted as the biggest rosacea study ever undertaken, Galderma has released results from the Phase IV study into Oracea. This study was called ORCA. We learn from the Galderma Press Release that ORCA stands for Oracea for Rosacea: A Community-Based Assessment. We also learn how to correctly pronounce Oracea, should that interest you.
Phase IV trials typically try to replicate the success and safety of drugs seen in Phase III trials, but on a much larger scale. Phase IV trials are conducted after a drug is already generally available.
The ORCA study was able to confirm that the majority of sufferers of the papules and pustules of rosacea were clear or near-clear after 12 weeks of being on Oracea. The redness associated with the rosacea lesions was also similarly reduced after 12 weeks.
GALDERMA ANNOUNCES RESULTS OF LARGEST-EVER ROSACEA TRIAL
Community Based Trial Studying Oracea (OR-AY-SHA) was Designed to Reflect Real World Conditions when Managing Papulopustular Rosacea
Fort Worth, TX – October XX, 2010 (yes they really did a release with a date of XX, and released it as a Word Document whatsmore).
A community-based study of 1,421 patients with mild to severe papulopustular rosacea (PPR), found that in patients suffering from PPR, Oracea® (doxycycline 40 mg) effectively reduces rosacea pustules and papules when used as a monotherapy treatment or when added-on to other topical rosacea therapies
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In the monotherapy arm (Oracea prescribed on its own as a rosacea treatment), IGA (investigator global assessment) scores showed about 75% of the 826 participants were clear or near clear by week 12 while CEA (clinician erythema assessment) scores showed about 75% had no or mild erythema after 12 weeks.
Adverse events that occurred in more than 1% of the safety population included diarrhea (1.2%), nausea (1.3%), and headache (1.0%).
For background see also the Clinical Trials register entry NCT00892281;
ORCA – Oracea® for Rosacea: A Community-based Assessment
A Phase 4, Open-Label, Multicenter, Community-based, 12-Week Trial Assessment of Effectiveness, Safety, and Subject Satisfaction With Oracea® [Doxycycline, USP] Capsules 40 mg (30 mg Immediate Release & 10 mg Delayed Release Beads) When Used as Monotherapy or as Add-On Therapy to Existing Topical Regimens for the Treatment of Rosacea
Enrollment: 1421
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009
Galderma is under threat in the market for sub-antimicrobial treatments for rosacea. Mylan Pharmaceuticals is hoping to be able to manufacture Generic Oracea in the first quarter of 2011.
