How would you like Metrogel and Finacea to be over the counter?

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Does the trip to the doctor, taking the paperwork to the chemist and then negotiating the insurance minefield get you down? Well you are not alone – many rosacea sufferers despair at how much it takes to get hold of your favourite prescription treatment.

Well what would it take for the rosacea treatment main stays Metrogel and Finacea to become available over the counter? Read on to find out how they might just become much easier to get hold of.

In recent years over 100 medications have made the switch from prescription to over the counter. What exactly is required for a treatment to become eligible for OTC status? The FDA examines the data available for a drug and looks for the compliance according to the following

  • the drug must demonstrate proven efficacy
  • the drug must possess a wide safety margin
  • and must exhibit understandable labeling for proper use.

The authors tells us that even though both Metrogel and Finacea have been in use for 10 years, more toxicology studies may be required to meet the current medical guidelines.

Safety profile of Metrogel and Finacea

The safety profile of these 2 drugs during pregnancy may be needed to be taken into account and have a bearing on the outcome of an investigation.

Rosacea sufferers can have some confidence in the reclassification though, because there is a precedent – Adapalene. Adapalen is classified as pregnancy category C (not enough research to know) and was approved for OTC sale.

Metronidazole and Azelaic Acid are both pregnancy category B (no risks have been found) so already offer a higher level of pregnancy safety.

Finacea is not absorbed into your body

The article mentions that the active ingredient in Finacea – azelaic acid 15%, when applied topically once a day for 8 weeks, did not increase the blood plasma levels to any detectable level. That is they were unable to measure anything to say that the azelaic acid was making it way from the skin to the blood and thus not around the body.

Metrogel has low absorption into your body

By comparison, Metrogel 1% gel applied once per day 7 days did result in a measureable amount of system absorption, but this amount was less than a single 250mg dose of oral metronidazole.

All good news so far

So far it all seems like good news, that the stage is set for the possible push for reclassifying Metrogel and Finacea as over the counter treatments – something that will surely benefit a large number of rosacea sufferers.

Article Abstract

Prescription to Over-the-Counter Switch of Metronidazole and Azelaic Acid for Treatment of Rosacea

Jean S. McGee, MD, PhD; Jonathan K. Wilkin, MD

AMA Dermatol. Published online July 3, 2018.

In 1951, the Durham-Humphrey Amendment to the US Federal Food, Drug, and Cosmetic Act of 1938 was enacted to label medications into 2 specific categories: prescription vs over the counter (OTC). This amendment required that any habit-forming or potentially harmful medications be dispensed under the direct guidance of a health care professional.

“Rx to OTC switch” is defined as the transfer of prescription drugs to OTC status; it is a data-driven process, rigorously regulated by the US Food and Drug Administration (FDA).

For the switch to occur, the candidate drug must demonstrate proven efficacy and a wide safety margin and bear understandable labeling for proper use. In recent decades, the increased demand by consumers to take charge of their own medical care has impelled the prescription to OTC switch of more than 100 medications that were previously available only by prescription.

In this Viewpoint, we consider the possibility that the topical treatments for rosacea, specifically metronidazole and azelaic acid, should undergo review for the prescription to OTC switch. We outline the potential advantages and disadvantages of such a switch.

Finacea Available OTC in Australia

Finacea is currently available over the counter at pharmacies in Australia. You can expect to pay around $30 AUD for a tube.

See the following links for possible online sources of Finacea: ChemistDirect

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About the Author

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

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5 Reader Comments

  1. David Pascoe says:

    Comment via facebook.

    “My insurance last year placed Metrogel generic in Tier 1 and I hade $10 cop pay. This year that same small tube was placed in Tier 2 and my insurance pays nothing. This week I paid $101 for the same medication that cost me $10 in November. It would be nice to get the med over the counter if it was affordable.”

    • David Pascoe says:

      That is a good question though – even if and when they do go over the counter, how much more affordable will they be overall? Will many still be looking for medical insurance to help cover the cost? Only time will tell.

  2. Lynnda Tenpenny says:

    And if you are under Medicare, forget about any of the standard rosacea creams. You can’t afford them. It’s ridiculous.

  3. David Pascoe says:

    Comment via email.

    “I have Ocular Rosacea and use Doxycycline 50mg one capsule twice a day and the co-pay is $47 US per month even with a Medicare supplement, with full price around $145. For the facial dermatitis I use Metronidazole Cream twice a day. This is a 45 Gm tube and last about 4 months. The co-pay is $80 US. I was originally given a prescription for Metro Gel, but the co-pay would have been $150. Fortunately the cream works pretty well.

    Stan”

  4. David Pascoe says:

    Comment via email.

    “I wouldn’t like Metrogel to be over the counter unless it’s price is much lower. Right now it is $200 in Ontario,Can. “

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