FDA extends review period for linaclotide NDA to treat constipation

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Apr 23 2012

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced that the U.S. Food and Drug Administration (FDA) notified the companies that it will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).

An additional analysis of existing data was recently requested by the FDA to further characterize the relative effect of the two doses of linaclotide that were studied in the Phase 3 CC clinical trials. Since this analysis was submitted to the FDA within three months of the user fee goal date, the date has been extended by three months, in accordance with applicable regulation. No new data have been requested by the agency to complete the review. FDA action is now expected by September 2012. Ironwood and Forest continue to plan for a 2012 launch.

The efficacy and safety of linaclotide was studied in a clinical trial program of more than 2,800 patients for the treatment of IBS-C and CC. Additionally, over 3,200 patients were enrolled in ongoing open-label safety trials and more than 2,000 of those patients have received linaclotide for at least 12 months.

Source Ironwood Pharmaceuticals and Forest Laboratories, Inc.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Abdominal Pain, Chronic, Clinical Trial, Constipation, Efficacy, Food, Hypersensitivity, IBS-C, Irritable Bowel Syndrome, Irritable Bowel Syndrome with Constipation (IBS-C ), Nervous System, New Drug Application, Pain, Pharmaceuticals

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Glad to see IBS and gastroparesis and constipation and pain addressed

Lynne Smith says:

June 3, 2012 at 11:56 PM

I'm glad to finally see a medicine coming to help those with IBS, Gastroparesis, Constipation and gastro pain. Too many people have suffered too long. I hope the FDA releases this drug quickly if found to be safe.

Of course many drugs are released such as humara (can cause lymphoma, infections, etc) and many other drugs have severe side effects. The one side effect of a drug my daughter was prescribed was 'death' but with so few gastro medications available for these symptoms, many still took it. Domperidone has been an investigational drug for years. It's widely used all over the world, but the US has still to approve it for use except if the doctor is approved for prescribing it. Most doctors don't want to take the time to fill out the FDA paperwork. And since it's not approved fully by the FDA, insurances don't cover it. It's quite expensive for alot of Americans.

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