FDA Approves Rapivab for Flu Treatment

In December 2014, the FDA announced that it has approved the drug Rapivab as a treatment for acute, uncomplicated influenza infection. Rapivab is the first flu treatment administered intravenously in one dose. Rapivab is a neuraminidase inhibitor that acts by releasing viral particles from cells infected by the influenza virus. Other neuraminidase inhibitors are administered orally and inhaled. Rapivab offers a third administration choice for those suffering influenza infection and is manufactured by BioCryst Pharmaceuticals based in Durham, North Carolina.

A drug trial consisting of 297 participants confirmed Rapivab’s effectiveness for treating the flu virus. Participants were over 18 years of age and demonstrated confirmed influenza. Each was administered either Rapivab 300 milligrams (mg), Rapivab 600 mg or a placebo. None of the participants had shown symptoms of the flu for more than two days. Participants that received Rapivab 600 mg demonstrated relief from their symptoms 21 hours sooner than the participants that received the placebo. The study also indicated that participants using Rapivab 600 mg returned to a norma l temperature approximately 12 hours earlier than the participants that were administered the placebo. These results are consistent with the outcome of the administration of the oral and inhaled forms of neuraminidase. The trial did not include participants that suffered from more complicated symptoms of influenza.

Reported common side effects of the drug include diarrhea.

More serious side effects include significant skin reactions such as Stevens-Johnson syndrome or erythema multiforme. Stevens-Johnson syndrome is a serious skin condition in which the epidermis separates from the dermis after cell death. Stevens-Johnson is life threatening. Erythema multiforme can present as a mild rash to a severe, life threatening form known as erythema multiforme major.

Also reported were events of hallucinations, delirium, and abnormal behavior; however, there is no clear information on whether the drug was the direct cause of these developments.

The FDA warns that Rapivab and other neuraminidase inhibitors are not substitutes for the recommended early, annual flu vaccinations. The Center for Disease Control (CDC) recommends flu vaccination annually for all persons six months and older.

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