FDA Requests Additional Trial Data for SkyePharma Asthma Drug
Posted on: Thursday, 9 August 2007, 06:05 CDT
SkyePharma has reported on the FDA's pre-new drug application meeting for its asthma treatment Flutiform. The US regulator was said to have queried one development aspect of the Phase III clinical trial program, and has requested additional data.
SkyePharma says further discussions will be held over the coming weeks with the FDA to agree the scope of any additional clinical work. Undertaking this work could result in the filing of the Flutiform NDA being delayed to the second half of 2008.
SkyePharma estimates that the additional net cash cost of any additional clinical work over the period up to approval could be in the order of GBP3 million to GBP5 million. The company will make a further announcement when the FDA's requirements have been clarified.
Over 1,500 patients have been recruited to date (over 85% recruitment) in the current Phase III trials. The long-term safety study is now complete and the data is being collated.
Any additional clinical work required for the FDA is not expected to affect the timescales or costs of completing the development of Flutiform in Europe.
Flutiform combines the fastest onset long-acting beta-agonist (formoterol) and the most commonly prescribed steroid (fluticasone).
Commenting, Frank Condella, CEO of SkyePharma, said: "Although the potential requirement for additional clinical data would mean that we face some delay to the filing of Flutiform, we are pleased with the progress being made with the FDA on all other aspects of the planned filing and we are encouraged by the level of commitment of Abbott Laboratories, our US partner, to the project."
Source: Datamonitor
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