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 25 November 2017

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News

Trials of GERD drug ticalopride suspended because of adverse events

Trials of a new drug derived from the withdrawn GERD treatment, cisapride, have been halted following reports of 'adverse events'.

News image

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Ticalopride is an isomer of cisapride, and developers Sepracor had hoped it would prove safer.

Cisapride, which reached worldwide sales of nearly one billion US dollars, was withdrawn last year by makers Johnson & Johnson after reports of patient deaths.

Phase II trials of the new drug are being suspended this week while investigators study reports of adverse events in patients with gastro-esophageal reflux disease and diabetes.

Trials of ticalopride have been suspended.
Sepracor

Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, was running the trials.

A spokesman for Sepracor, of Marlborough, Massachusetts, USA, said, "Although it is unknown if these events are related to the drug, Janssen has decided that it is prudent to suspend the trials to better understand the observations made.

"Janssen has stated that it has taken steps to preserve the scientific integrity, in order to reinitiate the trials and facilitate regulatory acceptance of the results. Extensive pre-clinical and Phase I data provided evidence that the drug is safe at doses used in this study."

Report Copyright: Englemed Health News at http://www.internationalmedicalnews.com

Sepracor
25 April 2001

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