Collagenex is reporting today that Oracea is equally effective as 100mg of doxycycline. This latest 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.
The main point of the trial was to show that a dosage higher than Oracea’s 40mg a day, won’t result in a better decrease in papules and pustules, but may show side effects commonly associated with higher doses of antibiotics.
If Oracea is too costly to be a part of your rosacea regime, you should consider 50mg a day of generic doxycycline. This is likely to be a much cheaper alternative but also offer the same benefits as oracea.
A paper related to this press release was titled Anti-Inflammatory Dose Doxycycline (40 mg Controlled-Release) Confers Maximum Anti-Inflammatory Efficacy in Rosacea and had the following conclusion ;
Higher mg/kg doses led to higher plasma concentrations but did not lead to increased clinical efficacy. Anti-inflammatory dose doxycycline (40-mg controlled-release formulation) conferred peak anti-inflammatory efficacy in the treatment of rosacea.
From today’s Press Release:
Oracea is a patented, delayed release formulation of doxycycline, 40 mg, that is the only FDA-approved treatment for the papules and pustules associated with rosacea. Doxycycline at much higher doses is often prescribed off-label by dermatologists for the treatment of rosacea. The study demonstrated that the higher, antimicrobial dose does not provide a greater clinical benefit than the anti-inflammatory dose of 40 mg, controlled release. However, the higher dose was associated with a significantly higher incidence of adverse events.
…
In contrast, a clear difference was observed between the two treatment groups (Oracea vs. 100mg doxycycline) in the incidence of adverse events, primarily gastrointestinal reactions. Gastrointestinal adverse events, including nausea, vomiting, diarrhea and stomach discomfort, were observed in 26% of patients administered 100 mg of doxycycline versus only 5% in the Oracea group.
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This study has demonstrated that, in patients with rosacea, increasing the daily dose of doxycycline to 100 mg does not lead to greater efficacy than Oracea, but has a much greater incidence of gastrointestinal side effects. In addition, Oracea’s onset of action was not different from the 100 mg doxycycline dose.”
5 comments ↓
seems like they’ve tested it just about all they can for P&Ps…. hopefully they will move on to its effectiveness in ocular rosacea.
Indeed Collagenex has milked as much as they can to get Oracea as the rosacea treatment. If you consider that they once had the patent for Periostat (it expired) then you realize how much work they have done to get back to where they were before ; but this time marketed towards rosacea.
We will no doubt see ocular rosacea press releases as soon as their trials finish.
This is all good news for us, though – good sales means more money to be invested in R&D for products like Sansrosa.
davidp.
I hope that Restasis and low dose doxycycline some day become a much more used ocular rosacea treatment (if indeed they are effective… which is looks like they are) Both are very safe as far as side effects go.
Then if col-118 or something similar passes, and we had a decent treatment for flushing/redness, we would have a decent way to actually treat all parts of this multi-pronged disease.
I just returned from the pharmacy without my prescription for Oracea because it costs way, way way too much. Apparently Oracea is simply low dose sustained release doxycline. I think I could get doxycline for far less money. I think this is a good example of a drug company trying to rip off consumers. Why did my doctor prescribe this instead of doxycline? Did he get a free vacation to the Bahamas? Did he really know how much it cost?
Hi Eric,
Collagenex hope that with insurance the co-pay will be under $25. They also have a rebate card to offer $25 towards the price. I don’t imagine that anyone without insurance would find Oracea compelling – generic doxycycline is always going to be a cheaper option.
Oracea is marketed as a treatment for rosacea, other antibiotics haven’t been tested and approved directly for rosacea. Thus Oracea has high visibility so it is easy for doctors to prescribe it.
Good luck !
davidp.
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