Irritable Bowel Syndrome Message Boards

He makes this important political point about the future attempts from Drug makers for trials of IBS Drugs in this earlier correspondence:

Is there a future for IBS drug therapy?

The US Food and Drug Administration (FDA) has declined a new indication for a drug which is already marketed (see http://www.ibsgroup.org/forums/index.php?%2Ftopic%2F136681-salix-pharmaceuticals-says-it-expects-the-us-fda-to-decline-approval-of-its-drug-xifaxan-in-its-current-form-to-treat-non-constipation-ibs%2F ).

The drug company jumped through hoops to provide sufficient patients during clinical trials despite the FDA changing the endpoints for the drug during the trials. We believe the safety profile of the drug is stellar. Studies indicated that a greater percentage of patients benefited from the drug than placebo and better than some existing therapies.

So, we ask the question: Why would any other Pharma spend millions to bring a drug to the FDA only for it to be denied? This is the 3rd time this has happened at the FDA.

We believe it would be in IBS patients best interest to act now to educate the FDA on the quality of life issues that IBS sufferers must endure. If we don't act now then I believe we will be abandoned by the pharmaceuticals.

If you suffer from IBS, I encourage you to write to these individuals at the FDA to let them know, in your own words, what it means to suffer from IBS. Post your email below and any response you receive.

CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF THE CENTER DIRECTOR
DIRECTOR
Janet Woodcock, M.D.
woodcockj@cder.fda.gov

CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF NEW DRUGS
DIRECTOR
John Jenkins
jenkinsj@cder.fda.gov

Cheers.

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ibs-d (pseudo)with pain and bloating

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