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news.Map Pharmaceuticals has announced that in a pharmacokinetic clinical trial, unit dose budesonide demonstrated lower systemic drug exposure when compared to the currently marketed conventional nebulized budesonide.
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The clinical trial was a randomized, open label, cross-over study evaluating the pharmacokinetic profile of two doses of unit dose budesonide (UDB) given twice daily in 32 adults with mild to moderate asthma. A 0.135mg dose of UDB was compared as an alternative to a 0.25mg dose of conventional nebulized budesonide given twice daily, and a 0.25mg dose of UDB was compared as an alternative to a 0.5mg dose of conventional nebulized budesonide given twice daily.
In this study UDB demonstrated faster times to maximum blood concentrations as compared to conventional nebulized budesonide, and had similar maximum blood concentrations. No serious adverse events were reported in the study and nebulization time for UDB in this adult population was shorter than for the currently marketed conventional nebulized budesonide product.
UDB is Map Pharmaceuticals’s proprietary nebulized formulation of budesonide, currently in Phase III clinical development, for the potential treatment of pediatric asthma. UDB is designed to be administered more quickly and to provide efficacy at lower doses than conventional nebulized budesonide, which is the current leading treatment for pediatric asthma.
Timothy Nelson, president and CEO of Map Pharmaceuticals, said: “These results are consistent with our previous clinical studies, and we believe provide additional support for the safety of our next generation pediatric asthma therapy.”