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Methylphenidate Patch

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  • Methylphenidate Patch

    • Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee Review

    Oct 27, 2005 - Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) and Shire Pharmaceuticals Group plc (LSE: SHP) (NASDAQ: SHPGY) (TSX: SHQ) announced today that the amended New Drug Application (NDA) for MTS (methylphenidate transdermal system) will be reviewed by the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee at their scheduled open session on December 2, 2005. MTS is a transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. The NDA amendment has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 28, 2005.
    • About Noven

    Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a developer of advanced transdermal drug delivery technologies and prescription transdermal products. Noven's prescription patches are sold in over 30 countries, and a range of new patches are being developed in collaboration with Shire Pharmaceuticals Group plc, Novartis Pharma AG, P&G Pharmaceuticals, Endo Pharmaceuticals Inc. and others. Noven is committed to expanding the universe of available transdermal therapies for the benefit of patients, partners and shareholders. See www.noven.com for additional information.
    • About Shire

    Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), renal diseases and human genetic therapies. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US. For further information on Shire, please visit the Company's website: www.shire.com.
    • About MTS and Methylphenidate

    In pivotal clinical studies managed by Shire, MTS was generally well tolerated and adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate. The most common adverse events reported by patients who received MTS in clinical trials were: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite, affect lability, insomnia, tic, and nasal congestion.

    Methylphenidate should not be administered to patients with: glaucoma; tics, Tourette's syndrome or a family history of Tourette's syndrome; current or recent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse of methylphenidate may lead to dependence and careful supervision following withdrawal from abuse is warranted. Methylphenidate should not be given to patients with a history of drug dependence or alcoholism. Methylphenidate should not be used for the prevention or treatment of severe depression or normal fatigue states. Growth should be monitored in patients treated with methylphenidate. Use with caution in patients with psychosis, history of seizures or EEG abnormalities, hypertension, a history of drug dependence or alcoholism. Rare cases of visual disturbances have been reported with methylphenidate use. Hematologic monitoring is advised during prolonged therapy.

    The content presented for background information and is based on a press release. The medication discussed is not yet available and has not been approved by the FDA..

    Contact Noven Pharmaceuticals, Inc. Joseph C. Jones, 305-253-1916
    Steve

    Dum spiro spero....While I breathe, I hope

    Tourette Canada Homepage
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  • #2
    Methylphenidate Patch

    This would be very interesting to see how effective this would be. This would stop some of the issues people deal with like having their kids rx stolen.
    Janet

    TSFC Homepage

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    • #3
      Methylphenidate Patch

      issues people deal with like having their kids rx stolen.
      How common a problem is this and what type of medications are targets? I presume it has to do with street use of Rx medications?
      Steve

      Dum spiro spero....While I breathe, I hope

      Tourette Canada Homepage
      If you enjoy the TC Forum, please consider a Tourette Canada membership
      Please visit our sister Forum: Psychlinks Psychology and Mental Health Support Forum

      Comment


      • #4
        Methylphenidate Patch

        Street drugs cause stupidity. Period.

        People do not realize that Ritalin 'speed' and street Speed are not the same thing. Dosage alone is very different. But, you can apparently turn a bottle of Ritalin into quite a speed hit. I have no idea how - I don't do those kinds of things. I have enough trouble with Nyquil. But Provigil and Ritalin are controlled for that reason - the FDA believes they can be abused, and they are right. How much abuse Provigil gets is beyond me, but oh well.
        Darin M. Bush, The Tourette Tiger, author of "Tiger Trails"
        http://www.facebook.com/tourettetiger

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        • #5
          Methylphenidate Patch

          It is more common than you think that ritalin is stolen for street use. we had our home broken into twice in one month in 2003 and the only thing taken was RX. When I reported it it was told to me that it is a regualr occurrence and that the tablet can sell for $15-20 each on the street. I was shocked back then, not so shocking now when I hear stories. Hence the reason I support slow release if anything.
          Janet

          TSFC Homepage

          Comment


          • #6
            Methylphenidate Patch

            transdermal therapies can be effective but sometimes do not stick to the skin or they can cause rashes and leave sticky behind.

            sounds like a possible option, but those with TS are not recommended to use the patch if I am reading it right.

            dose and how it is absorbed can be a concern with patches too.

            Interesting option though.
            PJK

            Comment


            • #7
              Methylphenidate Patch

              Is it that those with TS shouldn't use the patch or is it that those with TS shouldn't use Ritalin?
              Janet

              TSFC Homepage

              Comment


              • #8
                Methylphenidate Patch

                Drug companies that make stimulants are still including that the stimulants (Ritalin, Dexedrine, etc.) are contraindicated for TS.

                This is based on earlier findings that children taking stimulants developed TS. Recent studies have disproven this. Many children with TS show symptoms of ADHD first. After taking medications for their ADHD, their tics would emerge, leading people to think that the medications caused the TS. However, the tics would eventually have emerged without the medication.

                There is still more research required to determine the effect of stimulants on tics. Some people find that their tics increase in frequency when they take stimulants, and others find that their tics decrease.

                The prevaling opinion among researchers is that the drug companies are unlikely to remove the contraindication any time soon because of law suits that are still pending in the US.
                Cathy
                Forum Moderator

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