The study evaluated the results from phase 2 and phase 3 clinical studies. According to presenting author Rich Whitley of the University of Alabama in Birmingham, “Based on clinical data, peramivir is the first neuraminidase inhibitor (NAI) that has shown to be safe and effective as a single-dose therapy for patients with acute, uncomplicated influenza. According to a retrospective combined analysis of two clinical studies, a single dose of peramivir, administered intramuscularly (IM), alleviated flu symptoms, including fever, significantly faster than the studies’ placebo arms.”
In the two controlled studies that were conducted, 427 adults who showed flu-like symptoms received a single injection of peramivir in the first 48 hours of showing signs. Those injected with the drug found that their fevers were alleviated 24 hours sooner than those who received the placebo. Other symptoms were reduced as soon as 22 hours before the placebo recipients as well.
Although the drug itself isn’t exactly new, it’s not currently available in the United States, as the Federal Drug Administration (FDA) has not yet approved it. If this drug meets the FDA’s standards and requirements, BioCryst’s peramivir would be the first new NAI to become available in approximately 10 years. It would also be the only single dose injection treatment for the influenza virus in the United States.
In Japan and Korea, peramivir has been approved since 2010. Around 1 million Japanese patients have received the drug to date, while there have also been about 27 clinical trials in which approximately 2,700 subjects have participated in clinical studies. The flu hospitalizes an estimated 200,000 thousand people annually and claims 36,000 lives. Influenza is a virus that is constantly mutating, which makes keeping up with the vaccinations a tricky and complicated process.
(Photo courtesy of Steven Depolo)