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Watson Announces Top Line Uracyst(R) U.S. Pilot Study Results

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  • Watson Announces Top Line Uracyst(R) U.S. Pilot Study Results

    Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the U.S. pilot study evaluating Uracyst(R) (sodium chondroitin sulfate solution 2.0%) for the treatment of interstitial cystitis did not meet predefined efficacy endpoints.

    "Unfortunately, the results of the pilot study failed to demonstrate efficacy despite numerical separation of response between Uracyst(R) and placebo on certain measurements," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "We will work with Stellar Pharmaceuticals Inc. to further evaluate the response and assist in determining any next steps, but at this time we do not plan to allocate any additional resources to further pursue this development program. While regrettable, our decision will permit Watson to strategically refocus development resources on other product candidates in our development portfolio."

    About Interstitial Cystitis

    Interstitial cystitis is a chronic inflammatory disease of the bladder wall which causes pain, discomfort and frequent and urgent urination for those afflicted. The etiology of the disease is unknown. There is no known cure for the IC and currently approved products attempt to alleviate the symptoms of the disease. The quality of life for patients with IC is extremely poor, as they may need to void up to 60 times per day.

    About Watson Pharmaceuticals, Inc.

    Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health. Watson has operations in many of the world's established and growing international markets.

    In the U.S., the Watson brand portfolio includes RAPAFLO(R), GELNIQUE(R), Oxytrol(R), TRELSTAR(R), Crinone(R) , ella(R) and INFeD(R). In addition, Watson markets the following brands under co-promotion agreements: AndroGel(R), with Solvay Pharmaceuticals, Inc., and Femring(R), with Warner Chilcott Limited. The Watson brand pipeline portfolio includes a number of products in development in addition to URACYST(R), including three novel new contraceptives. All other trademarks are property of their respective owners.

    For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
    Would you like to talk with someone about your IC struggles? The ICN now offers personal coaching sessions that include myself, Julie Beyer RD on the diet and Dr. Heather Howard on Sexuality. http://www.icnsales.com/icn-personal-coaching/

    Looking for books, magazines & reports on IC? Please visit the ICN Shop at: http://www.icnsales.com: Your ICN subscription & purchases in our shop support these message boards, chats and special events. BECOME AN ICN ANGEL TODAY!

    Please remember that the information on the ICN is provided with the understanding that ICN, its founder, staff, volunteers, and participants are not engaged in rendering medical or professional medical services. We cannot and do not give medical advice. Only your personal physician can do this for you.







  • #2
    Hi Jill,

    I am a patient from the UK and am newly diagnosed with I.C. I have started a 6 week course of instillations of Uracyst (as it is licensed for use here) and I am so confused and dissapointed! After my 2nd instillation I noticed a sudden and significant increase in my symptoms (frequency and pressure - I do not experience any pain.) I had my 3rd instillation last week and the severity of symptoms has continued to increase. Before this, my symptoms were at a tolerable level (except when taking certain anti-depressants). Now they are unbareable, which is why I am sitting up at 3am writing this!
    I have been following all the advice regarding food and drink, and the only thing I have been doing differrently is getting th Uracyst instillations....I am thinking of contacting my Urologist and asking to discontinue the treatment.
    I find it very interesting that the American FDA did not approve this drug, and thought others on the forum might like to know of my experience with it. Previously I was going around 20 times a day - now I am going at least 40, and during my worst flare ups I am going 6 times every hour! I am gutted.

    Jem x

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    • #3
      Uracyst

      Jenn,
      I've done 7 Uracyst instills and I had some urethral irritation for a day or so, but I think it's helped. I'm sorry your experience hasn't been too helpful. J

      Comment


      • #4
        Hey Bjwright,

        I'm really glad you have found the treatment helpful! :-)) It just goes to show how confusing this condition is - there are so many treatments, and some people get better while others get worse! How much of an improvement have you noticed?
        Maybe a more 'traditional' bladder cocktail would work better for me. I read in the 'Professional Perspectives' newsletter on the ICA website, that "an alkalinized licodaine instillation containing bicarbonate showed sustained relief, with effects lasting longer than expected with licodaine, and some patients showing stable remission." I am thinking of asking my Doctor about this. But I know differrent doctors have differrent theories, so I'm not sure what he will say....
        Hope you continue to do well! Jem x

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        • #5
          Hi,

          Could it possibly be the size of the cathetor that is causing some of these symptoms?

          Jill
          "Where there is hope there can be faith. Where there is faith, miracles can occur."

          Comment


          • #6
            Hi Jill,

            I did consider that, but I never feel the catheter going in - I barely notice it at all! The aggrevation of my symptoms continues every day after the instialltions, rather than just being the day of/or the day after. I will arrange to see my Urologist and talk to him about it - maybe he will suggest this as a possibility too...It would be good it that was the reason, as it would mean I could continue with the treatment. Thanks for your help. :-)

            Jem

            Comment


            • #7
              Another thought...

              Jill,

              I have just had another thought - if not the catheter, could I be having a reaction to that gel stuff they use to help it slide in?

              Jem x

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              • #8
                Update - My 4th instillation was cancelled and as a result of my bladder having a 'rest' this week, my I.C. symptoms have finally gone back to a much more 'normal' level. This very much confirms to me that the Uracyst was indeed to blame for my condition worsening....However, as I am still waiting to hear back from my Urologist regarding the situation, I have decided to try one last instillation tommorrow to make 100% sure. If my bladder gets worse after that, I will definitely be ditching the Uracyst, and discussing alternative options with him...the quest goes on!

                Comment


                • #9
                  Yes, it can very well be the gel they use to insert the cath!! I have read this in many threads in the German forum.

                  Make them use another one if you go for your last instill to find out what really is the culprit!

                  Good luck!!
                  Sorry for any mistakes in my English - I am not a native speaker

                  Comment


                  • #10
                    Hi Goodnightmoon,



                    Thanks for your reply. I was actually at the clinic this afternoon to receive my 4th instillation and I asked the nurse if the gel might be causing the reaction. But she told me that they 'don't use a gel because the catheter is 'pre-lubricated'. So there goes that theory! She also told me that they use the thinnest catheter available, so it can't be that either. :-((
                    She agreed that if my symptoms worsen again, I should stop treatment and speak to my Urologist about other options. Unfortunately with it being Christmas, it might be a while before I get to see him again, but here's hoping the 4th one might not affect me so badly.... I'm hoping for a Christmas miracle! Lol. Hope you are doing well.
                    Jem x

                    Comment


                    • #11
                      Just thought I would share

                      Just thought I would share, a year ago I asked my uro about trying Uracyst.

                      His response was yes if you would like to try it you can, but I feel I should tell you a few things first. (I live in Canada and it is available here)

                      I have tried this on a # of IC patients and not had one person have any improvement from it.

                      It is expensive and not covered by our medical system so you will have to pay for it.

                      Not worth the time effort, and money, in his expirence, now I dounderstand everyone is different, but I havefoundthis uro to be pretty straight with me, with reguards to treatments, and expected outcomes, side effects etc,and pretty open minded about treatments he is not familar with. ( this is about my 6th uro looking for someone to help me and he is a keeper, wait list is a year to get into see him for first viist, he was worth the wait.)

                      In his expirences people who follow the diet the most strickly havethe best sucess treating IC, he does have treatment he can do and if things get bad and I need help getting things under control he can help with that, I am just call him. ( I havenot needed to do this as my GP is very good and will call him for me if things come up)

                      Anyways I am sure you can guess I decided not to try the Uracyst, but if the litterature about it changes I may, Ihavenot Xed it off my list just yet, as I have read some people have quite good success with this.

                      MG
                      My are with you all. May you all find a way to peace and joy in your lives.

                      Comment


                      • #12
                        Thanks for sharing MG

                        Wow. That is so interesting Mother Goose. Thanks for sharing that. That pretty much confirms my own experience. I'm glad it's not just me. Since my last post, I did get the 4th instillation. My symptoms continued to worsen and I could not bring myself to go back for the 5th and 6th ones. The nurses who administered the treatments were really understanding when I told them what was happenning, and told me they completely understood my decision.

                        Like you, I am sticking religiously to the I.C diet and have even started making my own soya free bread! You are right - it does help. I also drink Oat Milk cos I read that oats are considered really good for I.C patients. I did try a little bit of wine over the holidays and it went straight through me! Not worth it.

                        Jem x

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