Rosacea Support Group

Oracea User Reviews

Periostat (20 mgs doxycycline hyclate) has been helpful to some rosacea sufferers. Originally developed to combat periodontal disease (gum disease), periostat was approved by the FDA in 1998.

Recently the FDA approved the introduction of generic periostat equivalents. Ivax Pharmaceuticals and CorePharma are now free to sell their generic equivalents of Periostat.

Oracea is a new form of doxycycline, the same active ingredient as CollaGenex’s gum disease treatment Periostat. CollaGenex is shifting its focus to the dermatology market following the approval of generic competition for Periostat.

Colin Stewart, CollaGenex’s president and chief executive officer of CollaGenex, said he believes the product could “significantly expand” the current $500 million market for prescription drugs to treat rosacea.

The lead investigator for the trial, says

“Oracea provides therapeutic efficacy in rosacea through anti-inflammatory and anti-collagenolytic 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.”

Oracea is a new sustained release, once a day 40 mg tablet. 10mg of this 40mg is coated to delay the release of the doxycycline.

As part of the latest Phase III study for Oracea, when compared to the placebo, erythema showed a trend towards improvement. In a second study, the reduction in erythema achieved statistical significance as erythema scores improved (again against placebo).

CollaGenex is also developing a new once-daily version of Periostat, called Periostat MR, to protect it position in the dental market. Collagenex has restructured their sales team around the fact that Periostat is about to become a generic label.

The company is also seeking to expand the label for the drug’s main ingredient to include its use in treating a variety of skin disorders including acne and rosacea. Additionally Oracea may also be targeted towards treating ocular rosacea as well.

Promoting Oracea

Oracea is promoted as safe and effective for long term use. It was reported that the average duration of Oracea therapy is 4 months, compared to an average of 2.5 months for other rosacea prescriptions.

Collagenex are holding up to 6 patents relating to Oracea. These patents cover Oracea’s method of use, mechanism of action and pharmacokinetic profile (i.e. how it is absorbed and acts over time).

Collagenex reports that Oracea is equally effective as 100mg of doxycycline. That particular press release is a culmination of a trial that we have reported previously – oracea plus metrogel, better than 100mg doxycycline plus metrogel ? and also a 2007 SkinMed paper; maximum effective dose of doxycycline is 40mg a day.

See more about how Collagenex are promoting Oracea.

Oracea Plasma Concentration

The following graph, sourced from Collagenex, shows the blood plasma concentration of doxycycline for Oracea compared to 50mg once a day of generic doxycycline. The horizontal axis stretches out to 24 hours post dosage. The vertical axis is in nano-grams per milli-litre (ng/mL). The anti-microbial threshold is listed here as a concentration of 1000 nano grams/mL (i.e. 1.0µg/mL).

(click for a larger view)

I read this graph to suggest that Oracea is able to maintain a sustained release of the active ingredient doxycycline without venturing into anti-microbial territory. The advantage of a delayed release product is that Oracea can offer the `area under the concentration-by-time curve’ delivery, but at sub-antimicrobial dosage over 24 hours.

Method of Action

As part of Collagenex’ push to promote Oracea and Incyclinide, a new web site developing the idea that rosacea is a chronic inflammatory disease has been created. Be sure to check out the video of the the suggested Doxycycline Method of Action.

A Cheaper Alternative ?

As Oracea is a new prescription product it can be quite expensive, especially if you don’t have comprehensive insurance coverage. One possible alternative you could discuss with your doctor is 50mg a day of generic doxycycline. Whilst this dosage won’t have exactly the same profile in your blood, it is likely to be very close. As with all systemic treatments both, Oracea and a low dose of doxycycline can cause unwanted side effects so the supervision of your doctor is important.

Galderma and Oracea

Galderma is now the owner of Oracea, having purchased Collagenex in 2008.

Is Oracea Too Expensive?

Given that Oracea is really just doxycycline with a low dose and modified release mechanism, is it worth the extra expense compared to generic doxycycline low dose? Many are wondering if indeed Oracea is too expensive.

Your Thoughts

Have you tried Oracea or another low-dose doxycycline ? How long did it take to see some benefit ? Did you experience any side effects ? Please leave a comment below.

Featured Products

Related Articles: