Periostat (doxycycline) goes generic, get ready for Oracea

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 contains 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. As part of the latest Phase III study, 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.

So the potentially good news is that there should be cheaper periostat on the market shortly, and a new way to try low dose doxycycline once a day.

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.

Update: 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.

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Read more about: doxycycline, fact sheets, oracea

 

13 comments ↓

#1 Jennifer Worringer on 10.22.07 at 12:43 am

I have Rosacea that was mild until I turned 48. For a year, I have had red patches on one or the other side of my nose that refused to go away. Multiple daily applications of 1% metrogel and 15% Finacea failed to eliminate the red blotches.

I finally tried the Oracea prescribed in my third visit to the dermatologist. After 5 days of taking Oracea, the lesions are almost gone. I saw improvement after taking just two pills. The dermatologist said to take Oracea fo r1 week and not continuously.

#2 june hoffman on 10.27.07 at 8:22 am

My daughter started using Oracea about a year ago and it has done wonder for her acne. She went off of it for a few days and the acne returned. As long as she takes it her acne is clear. The dermatologist has always stated since it is a very low dose antibiotic it is not harmful in any way. She had tried other oral meds but was told that she could only take them for the short term, we are very grateful for Oracea.

#3 Marilyn Hartl on 12.22.07 at 6:56 am

I recently started taking Oracea for an irritated scalp. However, my previous doctor prescribed Doxycycline 100mg that worked in a matter of days, and was considerably cheaper. I called my new Dermatologist to get Doxycycline but she said Oracea and Doxycycline are the same thing. Is Oracea a low dosage? I’ve been taking Oracea 2 weeks and there has not been any improvement. Any suggestions?

#4 Digital Davo on 12.22.07 at 1:09 pm

Hi Marily,

Oracea is 40mg of doxycycline with 10mg of that in slower release to the remaining 30mg. At this dose it is considered low dosage or sub microbiotic dose. I would expect oracea to take longer to see a benefit compared to 100mg a day of generic doxycycline, so 2 weeks might not be long enough.

davidp.

#5 Thuy on 01.19.08 at 4:26 am

I was orginally prescribed to Oracea, but switched to Doxycycline 50mg due to the huge difference in cost. I was given a 4 day sample of Oracea. Should I just go ahead and take the sample and continue taking the 50mg of doxycycline after that? Should the treatment work the same?

Thanks!

#6 Digital Davo on 01.19.08 at 6:10 am

Hi Thuy,

You should be able to safely substitute the oracea for the doxy. I imagine the 4 day sample is just to confirm that you don’t have an allergy to any of the ingredients.

good luck !

davidp.

#7 Mary on 02.04.08 at 9:09 am

I have been taking Oracea for about 6 months. I keep having problems with a yeast infection, which seems to be related. The Oracea is working for the rosacea. Almost no one asks if I have a sunburn now. Any idea on the yeast infection?

#8 Ty on 03.20.08 at 4:42 am

Oracea is crap! It is no better than taking regular doxycycline, tetracycline, monocylcine, or any of the other multitudes of antibiotics that dermatologists prescribe us rosacea sufferers in an attempt to get us out of their offices. I have inflammatory rosacea with visible veins, redness, blotches, p&p, and daily burning, which drives me crazy. I have been on Oracea, as well as the other aforementioned drugs, and I have had only brief periods of relief. I’ve been on antibiotics now for one and a half years. I pray daily for relief from this awful affliction.

Ty

#9 Digital Davo on 03.23.08 at 1:29 pm

Hi Ty, Oracea is only ever promoted as being for the papules and pustules of rosacea (as indeed are other antibiotics). Oracea is just a low dose of doxycycline, so if you don’t get any benefit from doxycycline the oracea might not be for you - unless you are particularly looking for a low dose to avoid the side effects or continue long term for eg. Have you considered treatments like IPL ? davidp.

#10 rosita on 03.27.08 at 9:12 am

Hi all, I am seriously thinking on ask my doctor about oracea or better periostat.
Do you think periostat can help me?. I am 30 years old and my skin looks all burned. I’ve tried metrogel, rosacure, prosacea, all types of washes, also some oils somebody suggested…but every morning I see my face and I just want to cry…
This year in January I got a pretty bad cold taht developed into a infection, the doctor prescribed me tetracyclines and my face cleared for the first time in a year… but of course my stomach was aching and I was feeleign really weak in general… so I am wondering if one of those very low doses can help, how low can it be and still work?
thanks

#11 Digital Davo on 03.27.08 at 11:10 am

Hi Rosita,

One of the promoted advantages of a low dose doxycyline like periostat, oracea or 50mg per day of generic doxycycline is that they are likely to induce less of the normal negative reactions to higher doses of antibiotics. So this should be a reasonable alternative for you to try.

How it works is that you still get the anti-inflammatory benefits of the doxycycline, but the dose is low enough not to effect gut flora for eg. Collagenex published a study recently that showed that as far as rosacea symptoms are concerned 40-50mg a day will give the same benefit as 100mg a day i.e. a low dose should be just as good.

It is the ability of doxycycline (and indeed other tetracyclines) to interrupt the inflammatory pathway that gives a benefit to rosacea sufferers, not the eradication of bacteria or infection.

davidp.

#12 Sunny on 04.17.08 at 8:44 am

I started on Oracea one year ago, along with Finacea. I had unsatisfactory results with every other treatment. AND due to painful ocular rosacea, I was hoping to find something that would help my eyes AND my skin. The Oracea is fantastic for me!!! It started working immediately. But if I go a day or two without it, my eyes and skin react poorly.

My question is in regards to Oraceas interaction with oral contraceptives. I suffer from endometriosis and ovarian cysts. My gyn started menstrual suppression by low dose monophasic pills four years ago. This was a miracle for me, & very successful.

HOWEVER — soon after starting on the Oracea, I started spotting, which soon turned into 7-14 day long “periods”. It has only gotten worse over the last 11 months ; having now been switching my BCPs every 3 months and getting ultrasounds to see what happens. AND I am now getting cysts again as well.

I was wondering if there have been any studies as to how MUCH the Oracea might interact with oral contraceptives.(especially the low dose monophasic types)
I am not even concerned about pregnancy. I am flipping out b/c four years of successful menstrual suppression and no pain has now reversed back to the way things were before.

I really don’t want to stop taking the Oracea. BUT if it will help me stop having 14 day long periods, migraines & unbearable cramps — I guess I’ll have to deal with my skin itching, & my eyes feeling like there are small rocks rolling around under the lids every day. I lowered my dosage to every other day, but still the same results. My gyn knows I am on the 40mg Oracea & says it isn’t the cause.

Does anyone have any input, ideas, suggestions, info? Thanks!!!

#13 Stacey M. on 04.30.08 at 7:22 pm

I tried Oracea and had terrible results. If someone wants to have a flare up, I would recommend the Oracea. I had more burning and ruddiness than prior to taking the Oracea. The only thing that has helped me at all is Demulen (birth control pills). I also have found a little relief which was a complete fluke but better than all the topicals which only aggravate the condition. I have a pinched nerve in my back. It is extremely painful. My back doctor put me on Neurontin and Darvon. I can honestly say that it sometimes help with the burning in my face. I think doctors need to focus more in this area. I have tried lazer, Accutane, etc. You name it, I have tried it.

Stacey M.

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