is given three times a day for 28 days on and 28 days off.
The foundation also is working with Gilead's marketing team to establish the Cayston Access Program, a call center developed with the Cystic Fibrosis Foundation Pharmacy (a wholly owned subsidiary of the Cystic Fibrosis Foundation).
Gilead also is establishing a program designed to minimize barriers to access for Cayston for uninsured, privately insured, and government-insured people.
Truvada, Viread, Hepsera, Emtriva, AmBisome, Letairis, Cayston
and Ranexa are registered trademarks of Gilead Sciences, Inc.
The first co-primary endpoint of non-inferiority for mean percent change in FEV1 percent predicted at Day 28 was also achieved and Cayston met the statistical definition of superiority.
In the study, 268 patients were randomized to receive 28-day intermittent repeating courses of Cayston (75 mg three times daily) via the Altera([R]) Nebulizer System (PARI Pharma GmbH) or TIS (300 mg twice daily) via the PARI LC Plus([R]) Nebulizer over a 24-week treatment period.
Patients receiving Cayston had a mean increase in FEV1 percent predicted from baseline to Day 28 of 8.
In the study, 268 patients were randomized to receive Cayston or TIS over a 24-week treatment period.
All of us at Gilead extend our thanks to the investigators and to the people with cystic fibrosis who took part in the Cayston clinical trials," said Norbert Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer.
Cayston received conditional marketing authorizations in the European Union and Canada in September 2009 and was approved in Australia in January 2010.
Applications for marketing approval of Cayston
are also pending in Australia, Switzerland and Turkey.
will be made available in certain countries of the European Union, subject to the requirements of national authorities, beginning in early 2010.