Adverse reactions occurring in more than 5 percent of patients treated with Cayston
compared to placebo in Phase III studies were cough (54 percent versus 51 percent), nasal congestion (16 percent versus 12 percent), wheezing (16 percent versus 10 percent), pharyngolaryngeal pain (12 percent versus 11 percent), pyrexia (13 percent versus 6 percent), chest discomfort (8 percent versus 6 percent), abdominal pain (7 percent versus 5 percent) and vomiting (6 percent versus 4 percent).
The approval of Cayston
demonstrates that our drug development model is working and making a real difference in the lives of people with cystic fibrosis," said Robert J.
received conditional marketing authorizations in the European Union and Canada in September 2009 and was approved in Australia in January 2010.
June 21 /PRNewswire/ -- In a head-to-head, Phase III clinical trial of Cayston
delivered by the Altera Nebulizer System versus tobramycin inhalation solution in cystic fibrosis patients with Pseudomonas aeruginosa, the co-primary endpoint of non-inferiority for mean percent change in forced expiratory volume in one second (FEV(1)) percent predicted after 28 days of treatment was achieved.
Data Meet Statistical Definition of Superiority -
contains aztreonam formulated with lysine, a proprietary formulation of aztreonam developed specifically for inhalation.
The increase in sales of other products was due primarily to sales volume growth of AmBisome in Europe and Latin America and Cayston
in the United States.
The unique liposomal formulation improves the pharmacokinetic profile to once daily, versus twice daily and three times a day for TOBI (tobramycin) and Cayston
In Phase II clinical trials FTI was shown to be safe and to effectively maintain improvement in lung function achieved with Cayston
in CF patients with Pseudomonas aeruginosa infection.
Truvada, Viread, Hepsera, Complera, Eviplera, Emtriva, AmBisome, Letairis, Cayston
, Ranexa and Volibris are registered trademarks of Gilead Sciences, Inc.
Contract award: supply of medication cayston
* nebul 75 mg 84fl +88 f + ne.
Voluntary ex ante transparency notice: supply of drug cayston
75mg 84fl +88 f + e - cig 5500927490.