New Flu Rx Under FDA Review

Peramivir administered via injection and meant to alleviate symptoms with one dose

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The flu sends about 200,000 people to the hospital every year in the US, prompting research into treatment. Now, the FDA is looking at a new treatment that may reduce flu symptoms.

Early trials found the one-dose medicine safe and effective, and some Asian countries already use it.

Now, the US Food and Drug Administration (FDA) is reviewing peramivir for use in the US.

"Talk with your family physician about flu prevention."

Rich Whitley, MD, presented findings about the new flu treatment’s safety and effectiveness at an annual American Society for Microbiology conference Sept. 6 in Washington, DC.

He said the new medicine “has shown to be safe and effective as a single-dose therapy for patients with acute, uncomplicated influenza.”

Peramivir is injected to relieve flu symptoms. Flu symptoms include fever, vomiting, cough and fatigue. The flu kills 36,000 US patients each year, reports the Centers for Disease Control and Prevention.

Dr. Whitley, a professor of pediatric infectious diseases at the University of Alabama at Birmingham, discussed data from two studies of 427 adult flu patients total.

Researchers gave patients peramivir within 48 hours of flu symptoms starting. They measured patient temperatures and gauged symptoms for two weeks.

The medicine treated flu symptoms an average of 22 hours sooner than a placebo. Fevers resolved 24 hours sooner in patients who received peramivir.

Some patients experienced side effects. These included mild or moderate nausea, diarrhea and dizziness.

If approved by the FDA, peramivir would be the only single-dose and injection treatment for influenza in the US. The medicine is already in use in Japan and Korea.

The US Department of Health and Human Services and BioCryst funded the research.

Review Date: 
September 5, 2014
Last Updated:
September 9, 2014