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Thread: New Drug In Phase 3 Trials

  1. #1
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    Default New Drug In Phase 3 Trials

    There's a blurb in the latest issue of Dermatology Times that says Collagenex Pharmaceuticals has annunced a "highly significant" positive outcome for two phase three clinical trials designed to evaluate the efficacy of a drug called Oracea for rosacea treatment.

    It looks like it's not made for flushing (what else is new?) but it does show promise for reducing lesions. They claim it's a potent anti-inflammatory that's much safer and more effective than antibiotics.

    They are hoping to file their NDA in the third quarter of this year. They also claim it could expand the current $500 million market for prescription drugs for rosacea. Hah, if they only knew how much larger that number could be! If they make a product that works, we will buy.

    Tricia

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    Senior Member RedHotCanuck's Avatar
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    So if they file their NDA in the third quarter of this year, what timeframe could we possibly expect this to become available?

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    Senior Member irishgenes's Avatar
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    I found this post by Dr. Nase in archives, though it is missing from the Forum for some reason. Hope it is OK to re-post it here, because I am wondering if cutting a Periostat (20 mg. doxycycline) in half and taking half every 6 hours would have the same effect as Oracea. Heck, I'd even take a quarter every 3 hours if it would make broken blood vessels disappear.
    __________________________________________________ ____________________________________________
    Posted: Tue Jul 05, 2005 5:51 am Post subject: Oracea -- Sustained release doxycycline has added benefits
    Very interesting conversation with Collagenex's chief scientific advisor for my upcoming article.

    Periostat (20 mgs doxy) has been helpful to some. They have recently found that they can go up to 40 mgs per day and keep the anti-inflammatory effect and avoid any actions on bacteria.

    Oracea (the new sustained release 40 mg tablet) has more anti-inflammatory actions then does taking periostat twice daily. No idea why, maybe Pharmacokinetics. In the latest Phase III study, facial erythema actually decreased significantly and some broken blood vessels disappeared. Absolutely no explanation but interesting.

    Geoffrey

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    Senior Member irishgenes's Avatar
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    Quote Originally Posted by mikey
    So if they file their NDA in the third quarter of this year, what timeframe could we possibly expect this to become available?
    FDA claims new drug approval time is 12 months. Even if this were true, it wouldn't correspond to when the product hits the shelves.
    http://www.fda.gov/cder/reports/reviewtimes/default.htm

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