BioCryst Pharmaceuticals Inc. announced trial results related to Rapivab (peramivir injection), a neuraminidase inhibitor (NAI) for the treatment of influenza at the Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC) in Washington, D.C.
"Based on clinical trial 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," said presenting author Richard Whitley, University of Alabama at Birmingham. "In a combined analysis of two randomized placebo-controlled trials, a single dose of peramivir administered parenterally alleviated flu symptoms, including fever, significantly faster than placebo and reduced viral shedding."
The Oral Presentation Number V-1297 titled, "Single Dose Peramivir for the Treatment of Acute Seasonal Influenza: Integrated Analysis of Efficacy and Safety from Two Placebo-controlled Trials," verifies that a single dose intramuscular (I.M.) peramivir was generally safe and well tolerated, and reduced the duration of clinical symptoms and viral shedding in patient with acute uncomplicated influenza. The median time to alleviation of influenza symptoms after treatment with peramivir 300 mg was 113.2 hours, compared to 134.8 hours for placebo (p=0.161 adjusted for smoking behavior, influenza season and virus type, p=0.047 unadjusted). Median time to resolution of fever was reduced by 24.0 hours after treatment with peramivir 300 mg compared with placebo (p=0.004). Influenza viral shedding was significantly decreased during the first 48 hours after peramivir treatment (p=0.009) and detection of post-treatment viruses with decreased susceptibility to NAIs was rare. The treatment effect size is similar to that reported for other NAIs.
Poster Presentation Number A-012 titled "Single Dose Injections of I.V. and I.M. peramivir are Bioequivalent and Well Tolerated," presents data from two clinical pharmacology bioequivalence studies in healthy subjects. These studies confirmed that exposure to peramivir dosed by either IV infusion or IM injection is equivalent.
The presentation and poster are available at the Company's peramivir publications page. 
The peramivir New Drug Application (NDA) for the indication of treatment of acute uncomplicated influenza in adults is currently under regulatory review by FDA, with a PDUFA data of Dec 23, 2014. If approved, peramivir would be marketed as Rapivab (peramivir injection).
Date: September 6, 2014