Oracea available as Efracea (now Apprilon) in Canada

Written by on January 8, 2013 in doxycycline, Galderma, Oracea (40mg doxycycline) with 1 Comment

efracea-oracea-rosacea

This seems to have gone mostly unnoticed by rosacea sufferers, but in early 2012 Health Canada approved Efracea as a treatment for the papules and pustules of rosacea.

Called a Summary Basis of Decision for Efracea, Health Canada decreed:

Summary Basis of Decision (SBD) for EFRACEA

EFRACEA

Doxycycline monohydrate, 40 mg capsule
Galderma Canada Inc.
Submission Control Number: 143439
Date Issued 2012/02/28

On November 14, 2011, Health Canada issued a Notice of Compliance to Galderma Canada Inc. for the drug product, Efracea.

Efracea contains the medicinal ingredient doxycycline, as doxycycline monohydrate, which belongs to the anti-rosacea class of drugs.

Efracea is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea. The pathophysiology of the inflammatory lesions of rosacea is, in part, a manifestation of a neutrophil-mediated process. Doxycycline has been shown to inhibit neutrophil activity and several pro-inflammatory reactions.

The market authorization was based on quality, non-clinical, and clinical information submitted. The efficacy and safety of Efracea 40 mg capsules were based on two pivotal multicentre, randomized, double-blind, placebo-controlled Phase III studies in which 269 patients received Efracea 40 mg once daily and 268 patients received placebo for a duration of 16 weeks. Efracea demonstrated a clinically and statistically significant greater reduction in total inflammatory lesion count from baseline to Week 16 compared with placebo treatment (the primary endpoint). The safety profile was similar to tetracycline class antibiotics.

Efracea (40 mg, doxycycline monohydrate) is presented as a modified-release capsule. One Efracea capsule should be taken once daily in the morning, on an empty stomach, preferably at least one hour prior to or two hours after the meal. Dosing guidelines are available in the Product Monograph.

Efracea is contraindicated for patients who are hypersensitive to this drug, to other tetracyclines, or to any ingredient in the formulation or component of the container. Efracea is also contraindicated for women in the second or third trimester of pregnancy, for nursing women, infants, and children up to the age of 8 years, and for patients with myasthenia gravis. Efracea should be administered under the conditions stated in the Product Monograph taking into consideration the potential risks associated with the administration of this drug product. Detailed conditions for the use of Efracea are described in the Product Monograph.

Based on the Health Canada review of data on quality, safety, and efficacy, Health Canada considers that the benefit/risk profile of Efracea is favourable for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

Cheaper Than the US?

Given that Efracea is the same product as Oracea in the US, does the availability of Efracea in North America mean that rosacea sufferers in the US might gain cheaper access to Oracea ?

Please do let us know in the comments if you are able to source Efracea more cheaply in Canada.

Oracea is now Apprilon

[update:] Despite this approval for the doxycycline based Oracea in Canada, Galderma has since announced that Oracea will be known as Apprilon.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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1 Reader Comment

  1. Anon says:

    Oracea is Apprilon in Canada

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