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Pharmaceuticals / Submissions and Approvals

Synergy Petitions FDA to Update Linzess Labeling

March 2, 2018
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In a citizen’s petition to the FDA, Synergy Pharmaceuticals urged the FDA to require a revision of the approved package insert of Ironwood Pharmaceutical’s irritable bowel syndrome medication Linzess (linaclotide).

Synergy claimed the Linzess package insert fails to provide adequate information for its use because the incidences of adverse effects in its clinical trials are unclear or misrepresented.

The Linzess package insert does not note that clinical trial subjects could stop treatment for up to three days before resuming dosing, which could “strongly impact the reported rate of discontinuations due to adverse reactions.”

Synergy’s rival product Trulance (plecanatide) is approved for treatment of irritable bowel syndrome with constipation.

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