Monday, November 2, 2009

FDA authorizes emergency use of IV antiviral "Peramivir"...

As for as my knowledge goes Peramvir, is an experimental antiviral drug, and being developed by BioCryst Pharmaceuticals for the treatment of influenza. Peramivir is a neuraminidase inhibitor, acting as a transition-state analogue inhibitor of influenza neuraminidase and thereby preventing new viruses from emerging from infected cells.

The development of peramivir is supported by the US Department of Health and Human Services as part of the US government's effort to prepare against the threat of an influenza pandemic.

The drug has had a long history. An oral formulation was abandoned by Johnson and Johnson due to poor bioavailability. BioCryst Pharmaceuticals is now developing a injectable version, in partnership with Green Cross Pharmaceuticals in South Korea and with Shionogi Pharmaceuticals in Japan. The drug is in Phase II studies

More interesting recent news (Oct. 23, 2009) about this drug is that, FDA has announced the issuing of an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate based on one or more of the following reasons:
  1. the patient is not responding to either oral or inhaled antiviral therapy, or
  2. when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
  3. for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.....
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