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Thread: New SD Product (Dermadexin)

  1. #21
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    Cipher Pharmaceuticals' website says it's still in the pipeline, and there's no mention of any kind of time frame for its release. A forum member contacted them directly and was told it's set for "spring of 2017", which is clearly fast approaching, but who knows for sure if they're even sticking to that. I think many of us have been interested in this for a while now, but their opaqueness and lack of readily available info are a tad frustrating -- 99% of the internet search results for Dermadexin turn up a stock market analysis for the company rather than any details about the product itself!

  2. #22
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    Default From latest Q4 report

    Excerpt taken from document available on cipher pharma website
    In Q3 2015, Cipher received an Acceptance Review Notification for its 510(k) submissions for both Dermadexin™ and Pruridexin™ to
    the FDA. The notification confirmed that the submission contained all of the necessary elements and information needed to proceed
    with the substantive review. The FDA put the review on hold due to the uncertainty of the functions of the ingredients. The FDA
    requested that Cipher submit a “Request for Determination” (“RFD”) to the Office of Combination Products to determine whether the
    products are considered drugs or devices. In April 2016, Cipher submitted an informal RFD for Dermadexin and received a non-binding
    regulatory determination that the product, which contained nicotinamide (a new ingredient not listed in the device database) should be reviewed under the jurisdiction of the Center for Drug Evaluation and Research (CDER). The Company is currently working with
    consultants to determine the regulatory pathway for Dermadexin and Pruridexin in the U.S.

    In April 2016, Cipher received Health Canada approvals (via Natural and Non-Prescription Health Products Directorate “NNHPD”) for
    DexiDerm SD Cream and DexiDerm AD Cream (also known as Dermadexin and Pruridexin) and is developing launch plans for the
    products in Canada. DexiDerm CD was approved by the NNHPD in August 2016 and DexiDerm Scalp was approved on November 3,
    2016.

    In Europe, Helioclin® Dermatitis SD Cream (also known as Dermadexin) was approved in Europe in 2014 and Helioclin® Pruritus SD
    Cream (also known as Pruridexin) was approved in April 2016, as a Class III medical device. Cipher is seeking partners in Europe for
    Pruridexin and Dermadexin.

  3. #23
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    So the delay is, unsurprisingly, from being stuck in bureaucratic limbo in the USA. Yet more proof that the FDA is horrendously broken.

    I wonder how nicotinamide (a.k.a. niacinamide/Vitamin B3) is a "new" ingredient not listed in their database -- it's a common ingredient in the cosmetic industry ever since Procter & Gamble started using it about 17 years ago.

    Dermadexin is potentially the first revolutionary treatment for SD in a long time and it might struggle to even launch.

  4. #24
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    Product was ready in 2013 and still not available?

  5. #25
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    very impatiently waiting for this product.. it says approved in europe.. hopefully they market it asap..

  6. #26
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    It's been approved for sale in Europe since 2014, and in Canada since 2016. However it is still pending approval by the FDA in the US, and it seems that Cipher Pharmaceuticals has no intention of releasing it in either of these markets until it gets the FDA approval, so we will probably be waiting a long time still.

  7. #27
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    Default Cipher Pharmaceuticals is not waiting for the FDA

    Hello dear community,

    some days ago I phoned Cipher Pharmaceuticals. They told me that they are in Canada and are not waiting for the approval of Dexiderm by the FDA in the USA.

    They wait for the approval of Dexiderm by Health Canada and are seeking partners in Canada and Europe for it.

    So we have to wait and check their website (cipherpharma.com) regularly for updates.

    If anyone has questions, please feel free to ask.

    Best regards

    Tom-Sebastian

    If anyone has more information, please write it in this forum.

  8. #28
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    Hello Tom!

    Good job calling them. But I do find it strange them saying they're waiting for approval in Canada. From my understanding, Dermadexin/Dexiderm products are already approved in Canada since 2016. As you write they are seeking partners to out-license these products. The following text is from their recent Q3 report:
    DERMADEXIN™ AND PRURIDEXIN™
    In 2015, Cipher acquired the worldwide rights to three products from Astion Pharma ("Astion"), a Denmark-based specialty pharmaceutical company. The three products are focused on inflammatory dermatological diseases: Dermadexin™, Pruridexin™, and ASF-1096. Dermadexin™ and Pruridexin™ target common, chronic conditions that the Company believes are insufficiently addressed
    today. The terms of the agreement with Astion included an upfront payment of $6.0 million. The agreement includes approximately $34.1 million in additional payments contingent upon clinical milestones, regulatory approvals, commercialization and sales milestones in the both the U.S. and other regions. Over time, Cipher expects to out-license the products to partners in certain other regions.

    In Q3 2015, Cipher received an Acceptance Review Notification for its 510(k) submissions for both Dermadexin™ and Pruridexin™ to the FDA. The notification confirmed that the submission contained all of the necessary elements and information needed to proceed with the substantive review. The FDA put the review on hold due to the uncertainty of the functions of the ingredients. The FDA requested that Cipher submit a “Request for Determination” (“RFD”) to the Office of Combination Products to determine whether the products are considered drugs or devices. In April 2016, Cipher submitted an informal RFD for Dermadexin™ and received a non-binding regulatory determination that the product, which contained nicotinamide (a new ingredient not listed in the device database) should be reviewed under the jurisdiction of the Center for Drug Evaluation and Research (CDER). In July 2017, Cipher submitted a Pre-RFD with additional supporting information. The FDA determination remained the same, the product is a combination product comprised of two components; of a device, paraffin and a drug, pyridine-3-carboxamide and should be assigned to CDER.
    The Company is actively seeking a partner for Dermadexin and Pruridexin in the U.S.

    In April 2016, Cipher received Health Canada approvals (via Natural and Non-Prescription Health Products Directorate “NNHPD”) for DexiDerm SD Cream and DexiDerm AD Cream (also known as Dermadexin™ and Pruridexin™). DexiDerm CD was approved by the NNHPD in August 2016 and DexiDerm Scalp was approved in November 2016. The Company is actively seeking a partner for the DexiDerm portfolio in Canada.

    Helioclin® Dermatitis SD Cream (also known as Dermadexin™) was approved in Europe in 2014 and Helioclin® Pruritus SD Cream (also known as Pruridexin™) was approved in April 2016, each as a Class III medical device. The Company is actively seeking a partner for Dermadexin in Europe.
    I have been waiting for this since 2014, when I found out about it. I don't think it will launch this year, but 2018 probably. I hope it is an effective treatment but we'll see.

    Rikard
    Last edited by One; 7th November 2017 at 05:56 PM.

  9. #29
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    My name is Tom-Sebastian, I am 35 years old and I come from Germany.

    Some days ago I phoned the FDA, then 10 minutes later I phoned Cipher Pharmaceuticals and then I phoned Health Canada.

    Thanks for complimenting me.

    Thanks for your work and your effort.

    I hope that this product will be as good as it seems. It's the only treatment in the world that can cure seborrhoic dermatitis. I have nothing to loose any more.

    Antifungal agents never worked for me.

    Antibacterial agents never worked for me.

    When I used "Prednitop Cream" with the active component named "Prednicarbat", it worked. A cortison plus strengthening of the acid mantle of the skin is always working for me.

    Is that normal? I mean, the problem seems to be that the acid mantle of the skin is not intact at some parts of my skin, but fungi or bacteria were never a problem for my skin.
    Last edited by tomschulte; 8th November 2017 at 12:24 PM.

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