SkyePharma’s Asthma Drug Delayed

Following the meeting with the FDA, UK drugmaker SkyePharma said it may need to conduct more clinical work on its asthma drug Flutiform after the FDA questioned an aspect of the clinical trial design.

SkyePharma said it has concluded that, in order to provide further information to satisfy the agency, it may be necessary to generate additional clinical data to supplement the ongoing Phase III program.

The additional work could result in the filing of the Flutiform new drug application being delayed to the second half of 2008, the company added.