Oracea approved for much of Europe

Written by on April 28, 2008 in Galderma, in the news, Oracea (40mg doxycycline) with 3 Comments

In the news this week is an announcement that Oracea is on its way to being approved for sale in Germany, UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg and The Netherlands.

European Regulatory Authority (EMEA) Recommends Granting Of Marketing Authorization For MediGene’s Drug Oracea

MediGene AG announced that the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) has concluded the approval procedures for Oracea for the treatment of rosacea by issuing a positive opinion. The formal marketing authorization by the European Commission is therefore expected within the next few weeks.

I find it hard to get excited about Oracea press releases. Do we really need all this hooplah about just another antibiotic ? I sometimes feel that Oracea is a bit of a straw tower. Surely everyone out there knows that you can just take a similar dose of generic doxycycline and get the same benefits for a fraction of the cost ? Rather than just continue to be a bit grumpy, here are some reasons that I think Oracea might actually be a good thing for rosacea sufferers.

Low Dose Doxycycline: because of the development and testing of Oracea the concept of a low dose, or sub-antibiotic dose of doxycycline has come to prominence. Proving that it was still possible to get a therapeutic benefit from a low dose has been an achievement. The documented reduction in side effects from a low dose was also worth proving.

Benefits targeted at rosacea: The makers of Oracea, Collagenex previously held a patent related to another low dose doxycycline called Periostat. This drug was mainly prescribed for gum disease. Much of the supporting research around Periostat was motivated by treating gum disease. Periostat could be used to treat rosacea, but that would be off-label – something that some doctors would avoid. The patent relating to Periostat expired, so Collagenex looked to create a replacement product.

Oracea was developed from the start as a treatment for rosacea. Thus we now have some research telling us what dose is considered to be `low-dose doxycycline’, what benefits can be expected for rosacea sufferers and also proof of the long term safety.

Further R&D possible: by purchasing Oracea in large volumes, rosacea sufferers are sending a message to the parent company (Collagenex, which is now owned by Galderma) that this is a market that is worth investing in. Collagenex currently has another drug for rosacea in test: COL-118, or Sansrosa as it is also known. If profits from Oracea are channeled into new ground breaking drugs then that is obviously good for all rosacea sufferers.

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

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3 Reader Comments

  1. Alex says:

    It’s interesting to read the related press release from the CHMP. The recommendation is given “subject to certain changes in the product information and post-marketing obligations.” The procedure was actually initiated by the UK due to concerns regarding the induction of bacterial resistance. The product claims relatively to its long-term safety may not be as strong in Europe as in the US.

  2. Deneen says:

    just found out that my insurance won’t pay for it. what to do?

  3. David Pascoe says:

    Hi Deneen,

    Will your doctor offer you 50mg a day of generic doxycycline ? This could be a good alternative to Oracea, offering similar benefits for a cheaper outlay.


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