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Peramivir

Peramivir, developed by BioCryst Pharmaceuticals, Inc., has been shown to be more potent in vitro against influenza virus than oseltamivir or zanamivir and has been highly effective in preventing illness due to influenza in mice and ferrets. Peramivir is effective for both influenza A and B. Experimental data indicate that peramivir may have useful activity against many viruses of interest, including avian influenza, hepatitis B, polio, measles and smallpox. Peramivir is active in a hamster model of yellow fever, a finding which is not surprising, given the familial relationship of yellow fever and hepatitis C viruses as flaviviridae. Peramivir is active against other important flaviviridae such as West Nile virus and dengue.

In phase I and II human trials, peramivir was well tolerated and effective in reducing viral titers when administered orally. Phase III trials commenced in February 2000, but ongoing product development was halted due to relatively poor oral bioavailability and poor market interest in anti-influenza drugs. Although poorly absorbed orally, animal studies have shown the drug to be very effective in a parenteral preparation. According to BioCryst, an IV/IM preparation is currently in preclinical development. The New York Times recently reported that clinical trials will start this winter.

While full FDA approval will take considerable time, peramivir could be used in the event of an influenza pandemic even prior to FDA licensure under an Emergency Use Authorization (EUA) authority. The EUA authority allows the FDA Commissioner (after consultation with the Director of NIH and the Director of CDC) to approve use of medical countermeasures to diagnose, treat, or prevent serious or life-threatening diseases during an emergency when the totality of scientific evidence available shows that it is reasonable to believe that the product may be effective, that the known and potential benefits outweigh the known and potential risks, and that there is no adequate, approved, and available alternative to the product under consideration.