If you aren't already involved in GPACT's facebook, check it out! Exciting news has been posted that gives us all hope for better treatments and more knowledge in the medical community.
Here are two recent posts:
Good news from G-PACT via Tranzyme. We have a conference call w/ the FDA, top motility physicians & Tranzyme on Monday if Irene does not interfere. The goal is to emphasize the importance of streamlining Ulimorelin (TZP-102). This is, in part, the result of G-PACT's work w/ Tranzyme to give them educational info which they gave to the government to help continue research funding, our interactions w/ FDA, & team member who sits on FDA advisory board. We are making an im-PACT! From a Tranzyme conference call on 8/12/2011, Tranzyme estimates that approximately 4% of the US population has symptoms of Gastroparesis and that 19.9 million individuals worldwide have diabetic gastroparesis. The FDA recognizing that there are no other safe or effective treatments available has granted TZP-102 "fast track" status for review and approval in the US. Tranzyme intends to launch a Phase IIb clinical trial in the second half of 2011 for three months worldwide with the intent of showing that TZP-102 can treat what it considers the four cardinal symptoms of diabetic gastroparesis namely: nausea, early satiety, bloating and upper abdominal pain. Ulimorelin (aka TZP-102) is a new medication for GP that has been researched for several years in the diabetic population. It has had promising results with few side effects. It is only available to diabetics at this time during studies, but should be available for idiopathic and other forms of GP in the future.
Part of the G-PACT team including Mike Smith, VP, Carol Pasinkoff, FDA Rep/Board member, Carissa Haston, President, and Dr. Ken Koch of Wake Forest met with members of the FDA on Monday regarding the need for better treatment options. When we asked what an organization like ours can do to work with them and get better treatment options, they emphasized the importance of continuing our awareness and education and complimented us on what we are doing and how we are going about it. They are impressed with our active involvement in the lives of patients and our awareness and advocacy work. They want to continue regular correspondence with us. This proves how crucial awareness is! Until about a year ago, the FDA had NO idea how serious and debilitating these conditions are, and now they see things differently thanks to members of G-PACT. While we still feel like we have a ways to go, it was clear we have made some progress with them and they are no longer completely ignoring the impact this has and the great need for more options and easier access to certain treatment options. Awareness is vital according to them. We MUST keep it up. We can't do it without you, either. We will begin to work even harder with all of our patients to help you help us by providing you with resources you can use to ensure that they continue to hear from us and we do not get pushed on the back burner. They are open to options to help us get more treatments streamlined in some way, but we all must band together and fight, fight, fight! -CH