Birmingham Business Journal -- BioCryst Pharmaceuticals Inc. is seeking an extension from the U.S. Department of Health and Human Services on its Phase 3 study for flu drug peramivir.
The pharmaceutical company (Nasdaq: BCRX), which has operations in Birmingham, had originally planned to complete the third phase of drug testing for peramivir by the end of 2011.
The company has petitioned the HHS for an extension beyond the end of 2011 in an update Thursday on the results of its drug testing.
BioCryst is also seeking additional funding for the study and listed the following for reasons for extra funding and time:
• Revision of the primary efficacy analysis, to focus on the subset of patients not treated with neuraminidase inhibitors as SOC, in order to provide the greatest opportunity to demonstrate a statistically significant treatment effect.
• Increasing the total sample size, with further expansion of the number of sites.
• Expansion to additional geographical regions.
