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  • #61
    Re: LiRIS

    My guess is that they will probably have to do more studies on it before it will be put on the market or FDA approved.

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    • #62
      Re: LiRIS

      Interesting Lou Lou Girl...do you live in Canada by chance? If so, you are incredibly lucky to have the doctor involved in this up there. I was at least encouraged to see that Activis, the company that bought Allergan, seems to have in interest in developing products for urology. That other company Valient (sp?) that almost bought Allergan didn't sound like they were too interested in urology. Let's cross our fingers that Activis (now apparently adopting the name Allergan) will proceed forward and begin phase 3 soon. I hope this somehow gets fast tracked. I was reading Dr. Nickel's experience with using it on patients and some of the stories were pretty incredible and hopeful. He talked about some patients that were disabled were able to go back to work, etc. Every treatment that gets approved is another chance for a percentage of people to reclaim more of their lives. The more options available, the more likely an IC patient will obviously find relief of their symptoms...and the fact that it helped the most severe form of IC! That's exciting in my opinion! I'm going to continue to watch this one closely...
      Jill
      "Where there is hope there can be faith. Where there is faith, miracles can occur."

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      • #63
        Re: LiRIS

        Originally posted by jen74 View Post
        My guess is that they will probably have to do more studies on it before it will be put on the market or FDA approved.
        No. Jen74, I am not in Canada. I am down south. Funny you should ask though. My mother was a Canadian from Sarnia (spelled wrong) Ontario. Lou Lou girl

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        • #64
          Re: LiRIS

          Hey,
          So I just noticed on clinicaltrials.gov in March Allergan set up a phase 2 trial for Liris for patients with Hunners Ulcers. They are not recruiting yet, but it looks like things are moving ahead which is great to see! :-)
          "Where there is hope there can be faith. Where there is faith, miracles can occur."

          Comment


          • #65
            Re: LiRIS

            jvr, Well something goofy just happened while I was typing and I don't know if it posted part of message, or if it was just lost. So, I will begin again. Are you sure it is March of 2015? I participated in the Phase II trials last spring in 2014. I thought we would be seeing Phase III trials this year. I know there was some dispute during the trial here with some of the doctors involved. No more were recruits were taken. Liris worked for me. I had 15 pain free days. I was able to put down the Oxycodone for that long. That is no small feet. I was hoping that the dispute did not derail the progress of Liris. Let me know if it said 2015 and not 2014. Thanks, Lou Lou girl

            Comment


            • #66
              Re: LiRIS

              I know they last updated the clinical trials on the ICA website in November of Last year. They say the trial is ongoing, but who knows really because they are no longer accepting any people for the trials.

              The idea of LiRIS is good, but I think they are going to have to come up with a better system. From what I have read the device has to be inserted via a cystoscopy and two weeks later it has to be removed Via Cystoscopy. This seems like it would be Extremely expensive in the long haul as well as risky with having to have cystoscopy so many times with placement of this device and removal. I cannot imagine insurance companies covering this. I hope they would, but you know insurance companies are....

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              • #67
                Re: LiRIS

                Originally posted by Lou Lou girl View Post
                jvr, Well something goofy just happened while I was typing and I don't know if it posted part of message, or if it was just lost. So, I will begin again. Are you sure it is March of 2015? I participated in the Phase II trials last spring in 2014. I thought we would be seeing Phase III trials this year. I know there was some dispute during the trial here with some of the doctors involved. No more were recruits were taken. Liris worked for me. I had 15 pain free days. I was able to put down the Oxycodone for that long. That is no small feet. I was hoping that the dispute did not derail the progress of Liris. Let me know if it said 2015 and not 2014. Thanks, Lou Lou girl


                Yes, they will be recruiting patients with hunner ulcers in April 2015. If you google clinical trials.gov and then type liris in the search box, you will find info. I was told they want to present evidence of healed bladders to the fda. Unfortunately, the closing date of the trial is April 2017, so two more years of waiting.

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                • #68
                  Re: LiRIS

                  Hi Lou Lou,
                  The new one I saw says it was submitted March 17, 2015 and will start April 2015. It looks like it is estimated to run through until February of 2017. It only has 2 study sites, Kingston, Ontario and somewhere in Maryland. The other phase 2 trial study listed on their site says active, but not recruiting. It was set to complete I think it said February of this year, but is not showing being updated since then. This new one is specifically for Ulcers. I'm not exactly sure what Allergan is doing. Maybe they are more confident about getting FDA approval at some point with doing an ulcer only study because it has gotten such great results with those....hopefully Jill will fill us in on the latest soon. I'm happy to see it at least going forward though:-). I agree though, I'd like to see it available a lot sooner!!!
                  "Where there is hope there can be faith. Where there is faith, miracles can occur."

                  Comment


                  • #69
                    Re: LiRIS

                    Oh, thanks Jubilee! I must have missed your message while typing! I hope if the FDA does see how great this device is, that it will get quicker approval. Any idea if this is their goal? Or maybe like I mentioned, perhaps they are doing what is needed to help it get FDA approval eventually....
                    Jen some patients had healing continue long after 2 weeks. So it may not be something that has to been done every 2 weeks for all patients. I personally would see insurance companies covering this. I don't think Allergan would put all this money and effort into pursuing this device if not.. I could be wrong, but those are just my personal thoughts.
                    Last edited by jvr; 04-04-2015, 12:35 PM.
                    "Where there is hope there can be faith. Where there is faith, miracles can occur."

                    Comment


                    • #70
                      Re: LiRIS

                      It would be nice if it would become available sooner. I just hope insurance companies will cover it. There is also another study being done ( AQX- 1125) that looks hopeful. I really wanted to be part of this trial but it was not available here where I live. It really stinks that these trials take so long, but I guess they just want to be sure of the treatments safety wise.

                      Comment


                      • #71
                        Re: LiRIS

                        That would be nice if the device had lasting effects. I can see this helping people who do well with lidocaine bladder instillations as I think this is very similar except that I guess the device emits a steady amount of lidocaine into the bladder.

                        I would not bet on insurance companies covering it. I still remember when they first came out with Urgent PC. My urogyne offered it to me but said insurance companies did not like to cover it. My insurance denied coverage. Urgent PC is an acupuncture needle that is placed in a nerve in the ankle and is attached to a device that sends an electrical impulse to the nerve. You keep it in for like 30 minutes. It is done once a week for 12 weeks. It works more so for urgency and frequency. It costs like $800 a session. It has been around for over 9 years now and insurance companies are still denying coverage for it. It is maddening. I would like to think if a doctor says a person needs something or a treatment then the insurance companies should cover it.





                        Originally posted by jvr View Post
                        Oh, thanks Jubilee! I must have missed your message while typing! I hope if the FDA does see how great this device is, that it will get quicker approval. Any idea if this is their goal? Or maybe like I mentioned, perhaps they are doing what is needed to help it get FDA approval eventually....
                        Jen some patients had healing continue long after 2 weeks. So it may not be something that has to been done every 2 weeks for all patients. I personally would see insurance companies covering this. I don't think Allergan would put all this money and effort into pursuing this device if not.. I could be wrong, but those are just my personal thoughts.

                        Comment


                        • #72
                          Re: LiRIS

                          I wonder if it's maybe because urgent pc is basically acupuncture? I know not all like to cover that. I agree with you, if your doctor thinks it would be helpful they should let you try it. It is ridiculous. Liris is actually healing the the damage inside the bladder though. I would think if insurance companies are willing to cover instills which are not FDA approved (except DSMO), they would cover Liris. Let's hope! That would be terrible if not. Yes, I will also be curious to hear more about AQX-1125. You know which one I'm even more curious about is AF-219. That sounded like it had good results. I read about some of the ladies who posted their experiences on here and also another gal on another board who was happy with her results. It's just great to see a few different things in clinical trials right now. Let's pray that at least a couple make it through so we can have more options available soon:-)
                          "Where there is hope there can be faith. Where there is faith, miracles can occur."

                          Comment


                          • #73
                            Re: LiRIS

                            Yes, it would be great if these things make it through. We desperately need more treatments for this disease. I also pray that some scientist is out there looking into a possible cause for this disease. That would be even better if they were able to find a cause and possibly a cure! I know I am probably thinking to highly there, but still, it would be fantastic! We can only hope and pray..




                            Originally posted by jvr View Post
                            I wonder if it's maybe because urgent pc is basically acupuncture? I know not all like to cover that. I agree with you, if your doctor thinks it would be helpful they should let you try it. It is ridiculous. Liris is actually healing the the damage inside the bladder though. I would think if insurance companies are willing to cover instills which are not FDA approved (except DSMO), they would cover Liris. Let's hope! That would be terrible if not. Yes, I will also be curious to hear more about AQX-1125. You know which one I'm even more curious about is AF-219. That sounded like it had good results. I read about some of the ladies who posted their experiences on here and also another gal on another board who was happy with her results. It's just great to see a few different things in clinical trials right now. Let's pray that at least a couple make it through so we can have more options available soon:-)

                            Comment


                            • #74
                              Re: LiRIS

                              Jen, have you read some of the things they are finding from the MAPP Study? It's interesting stuff. I'm glad the NIH is seeing the connection IC has to Fibromyalgia, IBS, etc. finally. I think seeing this as a systematic issue beyond an end all bladder issue is good. They are finally looking outside the bladder for causes so I'm highly encouraged by where research is headed. Many think IC is a neurological issue which makes a lot of sense to me. I think as we get closer to the cause, better effective treatments will be forthcoming. I'm very hopeful!
                              "Where there is hope there can be faith. Where there is faith, miracles can occur."

                              Comment


                              • #75
                                Re: LiRIS

                                Originally posted by jvr View Post
                                Jen, have you read some of the things they are finding from the MAPP Study? It's interesting stuff. I'm glad the NIH is seeing the connection IC has to Fibromyalgia, IBS, etc. finally. I think seeing this as a systematic issue beyond an end all bladder issue is good. They are finally looking outside the bladder for causes so I'm highly encouraged by where research is headed. Many think IC is a neurological issue which makes a lot of sense to me. I think as we get closer to the cause, better effective treatments will be forthcoming. I'm very hopeful!
                                Hi jvr,

                                I'm not sure if the fda will speed up the approval process if they see such positive results with Hunner ulcer patients. My doctor did say we may see liris as an option in a year or two.

                                Jen,

                                I read in either the IC network newsletter or the ICA newsletter (can not remember which one) that researchers now believe the Hunner ulcer subset of IC is caused by a virus. I think this is great news for us and shows researchers are trying to find a cause. I would provide a link to the newsletter but I deleted my emails the other day.

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