The New Zelnorm-al (Part 2): More Thoughts On The Revival Of The 5HT4 Class
Looming return of Zelnorm to US market is milestone event for current regulatory climate. But FDA’s hands-on work to resurrect a different 5HT4 agonist, prucalopride, probably says more about what is truly different about the agency today.
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Zelnorm’s revival is self-conscious effort to revisit a decision made in “Safety First” era a decade ago. Is dropping CV outcomes standard for diabetes drugs next?
In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.
Serotonin receptor 4 agonists for use in constipation have been in limbo due to potential for CV risk; FDA is seeking recommendations about safety studies for the class from an advisory committee.