Atrial fibrillation (abnormal heart rhythms) can be a symptom of possibly serious heart conditions. Cardiome's lead drug -- an intravenous solution called Vernakalant that is designed to treat acute episodes of this disorder -- is awaiting FDA review with a decision expected before its Prescription Drug User Fee Act (PDUFA) date of Jan. 19.
The timeline that Cardiome pushed back yesterday was for the oral version of Vernakalant. Cardiome is testing this version to prevent, rather than just treat, atrial fibrillation in patients at high risk of recurrence.
Previously, Cardiome had expected to release interim data from a large 670-person phase 2b study in the fourth quarter, and final data from the study in the first half of 2008. The new timeline is for the interim data release to occur in the first quarter of 2008, so that more patient data can be included. Final study data is now expected in "mid-2008."
Reassuringly, Cardiome didn't increase the size of the overall study, and since this is only a phase 2 trial, there are no worries about the FDA looking unfavorably at the revised interim data timeline if oral Vernakalant makes it through phase 3 testing.
Episodes related to atrial fibrillation are currently treated with branded and generic versions of compounds like warfarin, sold by drugmakers such as Bristol-Myers Squibb
The delay in releasing trial data from the oral version of Vernakalant won't affect the timeline for FDA review of the marketing application for its intravenous (IV) cousin. The possibility of the FDA delaying approval of IV Vernakalant if safety issues popped up with the oral version had to run through the minds of Cardiome's management when deciding to delay the oral data until after the agency completes its review of IV Vernakalant.
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With an FDA advisory panel coming up in December, we'll find out soon enough if the delay of the oral Vernakalant interim results will have any effect on the agency's perception of the drug.
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