Troubling delay in FDA re-approval of Zelnorm due to submission of a Citizen Petition

[Jeffrey Roberts]

We recently became aware of a delay that has occurred with the decision at the FDA (Food and Drug Administration) as to whether to re-approve Zelnorm (tegaserod) following the meeting of the FDA Gastrointestinal Drugs Advisory Committee to discuss the reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with constipation (IBS-C) and our testimony on October 17, 2018.

On November 21, 2018 a Citizen Petition was submitted from Hyman, Phelps & McNamara, P. C. to the FDA requesting that the FDA "refrain from approving any new drug application (NDA) supplement (5NDA) to allow Zelnorm (tegaserod maleate) (“Zelnorm” or “tegaserod”) to be marketed unless the sNDA contains substantial evidence of safety and effectiveness for the proposed use in the proposed population under current applicable standards.". The FDA acknowledged the citizen petition on November 26, 2018.

We have read through the Citizen Petition and our impression is that it is asking for Zelnorm to be re-submitted as a new medication under a NDA (New Drug Application) because the patient group has now changed from women to women who do not have a risk for a cardiovascular event.

We have also read that pharmaceuticals have used a Citizen Petition to hinder a medication to enter the marketplace by slowing down the FDA decision process. This tactic had become so severe that in October 2018 the FDA cracked down on the "loophole" by issuing draft guidance to stop the use of the Citizen Petition.

Where does this leave Zelnorm?

We fully support access to Zelnorm (tegaserod) for patents with IBS-C and intend to submit a comment to the Citizen Petition to inform the FDA that patients are still demanding access to this medication and accept the risks associated with it. If you are inclined to submit your own comment, please follow this link at Regulations Gov for docket#FDA-2018-P-4490, https://www.regulations.gov/docket?D=FDA-2018-P-4490

[Jeffrey Roberts]

On February 1, 2019, Jeffrey Roberts, Founder IBS Patient Support Group, commented to the FDA in connection with the Citizen Petition for Zelnorm (tegaserod) submitted by Hyman, Phelps & McNamara, P.C. on November 21, 2018 for Irritable Bowel Syndrome with constipation (IBS-C). Read the comment here.

[Jeffrey Roberts]

Several additional comments have also been posted to the Regulations Gov folder for docket#FDA-2018-P-4490

1/ Comments from Sloan Pharma S.a.r.l and US WorldMeds, LLC., https://www.regulations.gov/contentStreamer?documentId=FDA-2018-P-4490-0003&attachmentNumber=1&contentType=pdf (Link will download a PDF)

2/ Comment from an anonymous individual:

"This drug needs to be reintroduced to the market. The claim from Hyman, Phelps & McNamara, P. C. is without merit and preposterous. Zelnorm has helped so many people when it was first released. None, and I mean none of the other meds on the market come close to relieving the pain and discomfort of IBS-C. I hope the FDA disavows the petition and moves forward in re-releasing the drug to the market."

[Jeffrey Roberts]

On April 1, 2019 it was announced that Zelnorm was re-approved by the FDA for marketing.

It's our understanding that the FDA responded to the Citizen Petition before the re-approval was made.