REDHILL BIOPHARM - News -> RHB-104 - Possible Breakthrough Treatment for Crohn's Disease

I get so excited when I read about this possible treatment, RHB-104, for Crohn's!  I've been watching this drug for over a year now.  This is a  treatment that if approved by the FDA, I will be jumping on it as soon as it becomes available.  No doubt!  This is the kind of treatment we need.  Everything else just treats symptoms.
So, why is this so exciting?  If you read current research about what causes Crohn's disease, you will see that researchers are leaning away from considering Crohn's disease an autoimmune condition.  They have found that there is an underlying cause for the immune response to activate.  Crohn's is said to be caused by a combo of 3 factors - Immune system abnormalities, environmental influences and bacteria.  I just wiki'd Crohn's disease and this is what is said about what is believed to be the cause - "Crohn's disease is caused by interactions between environmental, immunological and bacterial factors in genetically susceptible individuals.[4][5][6] This results in a chronic inflammatory disorder, in which the body's immune system attacks the gastrointestinal tract possibly directed at microbial antigens.[5][7] While Crohn's is an immune related disease, it does not appear to be an autoimmune disease (in that the immune system is not being triggered by the body itself)."
What this means is that people that have Crohn's disease do not have the immune system capabilities to destroy a form of bacteria that have been introduced into the body at some point in time.  As research has indicated, a large number of people with Crohn's disease happen to have the MAP bacteria in their body somewhere.  The exact location of the bacteria is not known at this time.  Who cares where it is, as long as a treatment is available that will destroy it is my opinion.
See why this makes me super hopeful?  If Crohn's is caused by this MAP bacteria & if this new combination antibiotic eradicates the MAP bacteria from people with Crohn's disease, this could be the answer to the Crohn's disease epidemic!  Can someone say CURE :)
Wouldn't that be glorious?  

Clinical trial for a new antibiotic therapy for Crohn’s treatment started:

Crohn’s disease is an inflammatory bowel disease which may affect gastrointestinal tract from mouth to anus, and has a wide variety of symptoms. Mycobacterium avium subspecies paratuberculosis (MAP) is believed to be associated with Cronh’s disease. Professor Dr. Saleh Naser, UFC College of Medicine, believes that MAP is the cause of the disease. He said, "Crohn's disease affects more than 750,000 Americans, yet traditional treatments only address the symptoms of inflammation and not the cause." He further added, "I have seen case studies where patients' lives have been restored following treatment, which removes MAP. I have high hopes that this clinical trial may lead to finding a cure." Dr. Saleh Naser will soon conduct clinical trials on a new antibiotic therapy acquired by RedHill Biopharma for curing the disease. 240 participants will be recruited for this double blind clinical trial.

http://health-beauty-2468.blogspot.com/2013/09/clinical-trial-for-new-antibiotic.html

Post-Diverticulitis Irritable Bowel Syndrome - New form of IBS Found by UCLA Researchers

This is interesting...  UCLA researchers have found that a form of IBS may be developed after a period where a person is diagnosed with diverticulitis.  The new condition is called post-diverticulitis irritable bowel syndrome (PDV-IBS).  The research also found that an increase in mood disorders was highly likely for people that suffer from IBS.  Read the article for the details.

UCLA researchers describe new form of irritable bowel syndrome / UCLA Newsroom:

UCLA researchers have described a new form of irritable bowel syndrome that occurs after an acute bout of diverticulitis, a finding that may help lead to better management of symptoms and relief for patients.

The discovery of this new condition, called post-diverticulitis irritable bowel syndrome (PDV–IBS), validates the irritable bowel symptoms that many patients report long after suffering a bout of diverticulitis but that many physicians have waved off as being part of the original condition, said Dr. Brennan Spiegel, an associate professor of medicine at the David Geffen School of Medicine at UCLA and senior author of the research.

"We've known for a long time that after some people develop diverticulitis, they're a different person. They experience recurrent abdominal pains, cramping and diarrhea that they didn't have before," Spiegel said. "The prevailing wisdom has been that once diverticulitis is treated, it's gone. But we've shown that IBS symptoms occur after the diverticulitis, and they may result from an inflammatory process, like a bomb going off in the body and leaving residual damage."

Vedolizumab, A New Treatment for Ulcerative Colitis & Crohn's Disease Looks Promising - Info & Clinical Trial Included

Vedolizumab, a potentially new treatment for UC and Crohn's disease is being fast tracked for review by the FDA.  The BLA (biologics license application) will give priority review to the ulcerative colitis application and standard review to the Crohn's disease application.
The part of the clinical trial that is most important to me is the said adverse effects that were found in the patients who participated in the study.  Based on the concluding trial results, the adverse effects of the drug is said to be the same as the placebo.  That's great news.  I'm going to continue to watch this drug for new updates and news pertaining to safety. So far, this new treatment by Takeda Pharmaceuticals looks promising.
I have also included the clinical trial abstract below.  

Gastroenterology & Endoscopy News - New IBD Drug, Vedolizumab, Receives Priority Review Status for Ulcerative Colitis: 

On Sept. 4, Takeda Pharmaceutical Company Ltd., announced that it received priority review status from the FDA for its drug vedolizumab, an investigational antibody for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). Takeda submitted a biologics license application (BLA) to the FDA in June for the treatment of CD and UC; the UC application will receive priority review, and the application for CD will be reviewed under the standard timeline.

NEW TREATMENT OPTION - SIMPONI® Receives Approval in UK for the Treatment of Ulcerative Colitis/ #UC

I just read that today Simponi was approved for the treatment of ulcerative colitis in the UK.  This may be a successful treatment option for people that have not been able to obtain remission with mainstream treatments for the disease.  Some people, like myself, have tried them all with no improvement.  It's very frustrating to hit that wall and run out of effective treatments..... actually, safe effective treatments.  If you just can't seem to get the inflammation and toll taking symptoms under control and you've taken into consideration the risks vs. the benefits, some people may find relief with this new drug.  This particular article does include the potential health risks from TNF-blocking therapies, toward the end of the article.  

If you are considering Simponi (or any immunesuppressing drug), please know everything about it before agreeing to the treatment.   Everyone should know what the risks are versus the benefits before beginning any kind of treatment like this.  Your doctor will not tell you everything about these drugs and from personal experience, most doctors down play the risks and don't even look at  family history/genetics when deciding if these treatments are appropriate.   It's disturbing when you know that the information you completed for your file, (providing family history) and screams *HIGH RISK*, and the doctor recommends the treatment anyway.   Sadly, it's probably because the doctor didn't even scan over this little piece of information that says a lot.  Another reason is because TNF-blocking therapies have become the conventional prescribing treatments for IBD now, despite their high side-effect profile.   

Personally, I would never consider being treated with an immune suppressing drug of this potency because of the numerous possible health problems that could result.  It's not worth it to me to put my entire body at risk of developing something life altering (conditions worse than what I'm treating) with the awareness that there are life changes that I can make that will encourage healing and repair of my digestive tract.  It takes determination to make the changes that are necessary and it takes longer to heal, but in my opinion, it's my overall health that I care about.  You will get there, I did.

Most doctors will say that diet is not a big contributor to IBD however,  it infact makes a huge difference in respects to your success with reaching remission. What foods you choose to eat WILL affect your health negatively or positively, it's a decision that you can control that will have a significance on your overall quality of life.  If you struggle with diet and need some guidance, send me an email.  Years ago I was clueless about what to eat and what not to eat.   I was blessed to have connected with a few very knowledgeable people that helped me in the area of diet.  I'm always willing to help people that need some support and suggestions, so feel free to contact me if you need some support.     

PR Newswire UK: SIMPONI® Receives European Commission Approval for Treatment of Moderately to Severely... -- LEIDEN, The Netherlands, Sept. 23, 2013 /PRNewswire/ --:

-- First and Only Subcutaneous Biologic Treatment Administered Every Four Weeks Approved for Ulcerative Colitis

Co-pay Assistance Programs List | UCERIS & Other Prescriptions

When I first heard of Uceris, it reminded me of the drug Entocort.  Both treatments are very similar - same active ingredient and both are time-released.  The only difference is that Uceris is released in the colon vs Entocort, which is released in the small intestine.  That explains why Entocort wasn't effective when I tried it years ago. Most of my inflammation at that time was located in the large intestine and part of the small intestine (terminal ileum - the last area of the small intestine connecting to the large intestine). 
People with Ulcerative Colitis experience inflammation specific to the large intestine/colon.  
Hopefully this medication will help with healing the lowest part of my colon - the most difficult area to heal from what I have read.   Maybe this could be an option that some of you may want to try as a safer treatment option .  

• IMPORTANT NOTE TO MENTION - This form of steroid does not produce the horrible side-effects that come with oral prednisone (aka - satans tic-tacs).  We all know what those side effects are if we have ever taken prednisone.  Due to the time-release of the drug at it's target location, very little of the medication is released into the bloodstream.  This is a very good thing!! 

What it says about Uceris @ www.uceris.com

About UCERIS

UCERIS (u-SAIR-us) is a medicine used to treat active, mild to moderate ulcerative colitis (UC). It's for people experiencing UC symptoms or a flare-up who are trying to reach remission, a period of time without symptoms.

UCERIS is a different kind of steroid designed specifically to treat UC. It decreases inflammation throughout the colon with a targeted delivery of medicine throughout the full length of the colon, where the disease is located.

Because of the way UCERIS is absorbed and processed in the body, most of it does not enter the bloodstream, and therefore it has a safety profile similar to placebo (sugar pill). UCERIS also helps heal the lining of the colon. UCERIS decreases the severity of inflammation in the colon, thereby helping to eliminate UC symptoms.

UCERIS is a single pill taken once a day by mouth for up to 8 weeks. Additional 8-week courses can be given for patients whose UC remains active. 

What happens after taking UCERIS? Unlike typical steroids, which act on the whole body, UCERIS targets the area where the disease is located. The medicine travels through the digestive system and stays intact until it reaches the colon. Once it dissolves, UCERIS forms a type of gel and slowly releases medicine to the full length of the colon.

Ok, so I just filled my prescription of Uceris and it's a pretty expensive drug for the time being (too new for a generic form to be available).  People with GI conditions and autoimmune disorders spend a lot of money on maintaining their health, from doctor co-pays to specialty food to the various medications one must take.  The monthly cost of this disease can be devastating.  I wanted to share the different savings offers that are available for qualified individuals.  

• Here is the list -  Please note:  I have not checked SCBN.org or goodrx.com about the offers.  I just did the searching and posting for you.  Offers status at this time on specific drug is unknown, as i didn't read each sites qualifying info andterms of offer.

$25 Co-pay Program | UCERIS (budesonide) Extended Release Tablets: - Manufacturer offer*

http://medicinecoupons.net/Medicine-UCERIS-coupon

http://www.internetdrugcoupons.com/Uceris-Coupon *This site gives people with no drug coverage an option to save.  The manufacturer does not have an offer for cash paying individuals (I have no idea why. Makes no sense when these would be the people that would need the most help paying for medication).

http://www.goodrx.com/uceris

https://www.pparx.org/ The Partnership for Prescription Assistance helps qualifying patients without prescription drug coverage get the medicines they need through the program that is right for them. Many will get their medications free or nearly free.

http://www.needymeds.org/ NeedyMeds is a 501(c)(3) non-profit information resource devoted to helping people in need find assistance programs to help them afford their medications and costs related to health care. 

http://healthfinder.gov/FindServices/SearchContext.aspx?topic=696 US Dept of Health Resource Page

http://www.scbn.org/