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US FDA Reviews IBS-C Candidates Both New (Tenapanor) And Old (Tegaserod)

Executive Summary

Ardelyx touts tenapanor's novel mechanism, favorable safety profile; advisory committee announcement reveals US Worldmeds’ bid to revive Novartis’ withdrawn Zelnorm.

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Zelnorm's Return: US FDA Panel Hands Down Split Decision On Constipation Drug's Target Population

Seven advisory committee members said the treatment for irritable bowel syndrome with constipation should be labeled for females at low cardiovascular risk; three panelists, including two cardiologists, supported a narrower indication limited to low CV risk patients who also suffer from severe symptoms.

US FDA Seems Ready For Return Of Zelnorm, But Seeks Advice On Best Subpopulation

Whether Sloan Pharma's irritable bowel constipation drug tegaserod should be indicated only for women at low cardiovascular risk, women who are severely symptomatic, or women who fall into both categories is a question for FDA's Gastrointestinal Drugs Advisory Committee; panel also is asked to discuss risk of psychiatric adverse events with the 5-HT4 receptor agonist.

Shire’s Prucalopride Brings Real-World CV Safety Data To US FDA Panel, But Will It Be Enough?

European postmarketing epidemiological study results ‘reasonably exclude’ a greater than three-fold increased risk of major adverse cardiovascular events with the constipation drug but, due to potential bias, cannot definitively exclude a possibly unacceptable level of risk, agency says.

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