Oracea

[Guide]

According to this initial report, Oracea works for rosacea sufferers:

"After 16 weeks' therapy, anti-inflammatory dose doxycycline 40 mg was significantly more effective in improving rosacea than placebo, providing a greater reduction in the total inflammatory lesion count (primary endpoint) than placebo." [1] 

"In addition, there were significant differences in the distribution of baseline and week 12 IGA scores in the PP group (P = .0012). At week 12, most participants (63.6%) had mild CEA scores; the distribution was significantly different from baseline (P = .0407). Only 7% of participants had treatment-related adverse events (AEs), mostly mild or moderate in severity. Thus the 40-mg formulation of doxycycline proved to be effective and well-tolerated in a real-world setting in participants with rosacea who were receiving topical therapy but still experiencing symptoms." Effectiveness and safety of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) once daily as add-on therapy to existing topical regimens for the treatment of papulopustular rosacea: results from a community-based trial.

According to one report, " A sub-antimicrobial dose of slow release doxycycline 40 mg daily is an effective long-term therapy for ocular rosacea. It is not associated with the side effects of long-term antibiotic therapy or the risk of resistance.' [2] 

An article issued in August 2012 reports, "it now seems clear that the role of antibiotics in patients with rosacea depends upon their anti-inflammatory rather than their antimicrobial properties." [1] Thus the emergence of Oracea. [5]

There is speculation that generic Oracea may be available according this 2010 report (More info}. However, this has never happened. 

Cost
The price range for Oracea is from $218 to $289 for 30 capsules (40 mg) at the different drug stores in the USA. Click here for the current price.

So if you are interested in asking your physician for a prescription you might want to read below about price discounts:

There was the Best Face Forward Program to obtain a 30 days supply of Oracea for $25, but now Galderma is offering a savings coupon. 

Click here to find out more about the CareConnect Savings Card. 
Exclusive rebates—save on your MetroGel; 1% and/or Oracea; prescriptions or go to bestfaceforward.com for savings cards. One report says 'the company is no longer honoring the $25.00 deal. Another report about this is similar. However, another report says the savings card works as long as you have insurance. If you don't have insurance there is a telephone number to call to ask questions:

1-866-954-5516

The web sites mentioned still show the savings card is available for the discount so the odds are Galderma will honor the savings coupon and if you are willing to jump through some Galderma hoops you may be able to save money. 

If you were low income you could get Oracea for free back in 2010 by asking your pharmacist questions how to do this. 

Prescribing Information

In Canada, the UK and in Europe Oracea is known as Efracea.



MHRA Product Info on Efracea

According to Galderma, "Oracea (doxycycline, USP) is the first and only oral therapy approved by the FDA to treat the inflammatory lesions (red bumps, blemishes, and pustules) of rosacea." It may not help the erythma or redness associated with rosacea.

Oracea was originally made by Collagenex which was bought up by Galderma for $420 Million in April 2008 has now been promoted by Galderma as a first line of treatment dermatologists should use along with topical Metronidazole (usually Metrogel - also a Galderma product or other Galderma topical forms of metronidazole). Galderma was formed in 1981 as a joint venture between Nestle and L’Oreal. David Pascoe has been following this closely and has more scoops on Oracea than anyone. If you have no idea what Oracea is, it is a special form of tetracycline called doxycycline in an enteric coated capsule which makes it timed released and only in 40 mg. doses which makes it 'submicrobal, anti-inflammatory' and not anti-bacterial. Supposedly Oracea touts the claim that it will not cause antibiotic resistance. Therefore, it is now being promoted as a long term solution for rosacea.

Joseph P. Shovlin, O.D., points out that "When Periostat went generic, CollaGenex re-introduced it as a 40mg, once-daily, time-released pill called Oracea, which gained FDA approval for treating rosacea in May 2006. Oracea is the drug of choice for rosacea, says Joseph Bikowski, M.D., assistant professor of dermatology at Ohio State University. However, the cost may be prohibitory. It is about $4 a pill. For that reason, some clinicians prescribe doxycycline off-label."

The New York Times reports that sales of Oracea for the first half of 2006 totaled $9.1 million. According to Pascoe he says that if he is reading the graph right, Oracea prescriptions numbered 1.2 million a month in December 2007. Oracea sales was worth approximately $104 million for the twelve-month period ending July 2009. This figure is up almost 200% from the previously reported sales of $52.5 million in 2007. Click here for Source

You can imagine how many prescriptions have been handed out now that Galderma is targeting dermatologists all over the world with this prescription drug for rosacea, touted as the 'only FDA approved oral prescription for rosacea.'

Business Wire reports that a "double-blind, placebo-controlled trial enrolled a total of 72 rosacea patients at 3 centers....The study successfully met this endpoint and demonstrated a statistically significant, greater reduction in inflammatory lesions at Weeks 12 and 16 in the Oracea + MetroGel group compared to the Placebo + MetroGel group."

A conference reports that "A multi-center, randomized double-blind trial compared the efficacy and safety of anti-inflammatory dose doxycycline 40 mg daily (Oracea) versus non enteric-coated doxycycline 100 mg once daily. Patients in both arms of the study were also treated with metronidazole1% (Metrogel 1%) once a day. At the end of 16 week, there was the same onset and extent of therapeutic effect in both groups based primarily on reduction in inflammatory lesions. The major difference in both groups was in the number of subjects who experienced gastrointestinal side effects, such as nausea, vomiting and abdominal pain. The non-enteric-coated doxycycline 100-mg once-a-day group reported significantly more side effects, especially gastrointestinal side effects, with no cases of nausea, vomiting or abdominal pain noted in the group receiving anti-inflammatory-dose doxycycline." [3]

Another report Pascoe brings out is that 100 mg doxycycline no better than Oracea. Pascoe also has an interesting article he entitles, "Galderma wants to own the Rosacea Market" which is worth reading.

The biggest complaint from rosaceans is the high cost of this prescription. Some have been getting rebates from Galderma but again and again the complaints are how much this prescription costs.

Paul says, "...There is no difference between delayed release 40mg Oracea vs. 50 mg doxycycline. The only difference is price..." Scroll down to Comment #82

"Efficacy of ORACEA beyond 16 weeks and safety beyond 9 months have not been established." [4]

"Treatment with doxycycline significantly reduced inflammatory lesions and improved investigator global assessment scores compared with placebo. Cathelicidin expression and protein levels decreased over the course of 12 weeks in patients treated with doxycycline. Low levels of protease activity and cathelicidin expression at 12 weeks correlated with treatment success. Low protease activity at baseline was a predictor of clinical response in the doxycycline treatment group." [6]

Annual Sales
"Oracea® Capsules had annual U.S sales of approximately USD 319 million for the twelve months ending March, 2013 (IMS Health data)." [7]

End Notes

[1] Doxycycline 40 mg Capsules (30 mg Immediate-Release/10 mg Delayed-Release Beads): Anti-Inflammatory Dose in Rosacea.
McKeage K, Deeks ED.
Am J Clin Dermatol. 2010;11(3):217-22.

[2] Treatment of ocular rosacea with 40 mg doxycycline in a slow release form.
Pfeffer I, Borelli C, Zierhut M, Schaller M.
J Dtsch Dermatol Ges. 2011 Jun 15. doi: 10.1111/j.1610-0387.2011.07723.x

[3] Skin &Aging Supplement to the February 2009
27th Anniversary Fall Clinical Dermatology Conference

[4] Product insert for Oracea

[5] J Drugs Dermatol. 2012 Jun;11(6):725-30.
Diagnosis and treatment of rosacea: state of the art.
Baldwin HE.

[6] J Am Acad Dermatol. 2016 Jun;74(6):1086-92. doi: 10.1016/j.jaad.2016.01.023. Epub 2016 Mar 5.
Improved clinical outcome and biomarkers in adults with papulopustular rosacea treated with doxycycline modified-release capsules in a randomized trial.
Di Nardo A, Holmes AD, Muto Y, Huang EY, Preston N, Winkelman WJ, Gallo RL.

[7] Lupin Receives Tentative FDA Approvals for Generic Nuvigil® Tablets and Generic Oracea® Capsules
Lupin Pharmaceuticals, Inc. Newsroom