RAPIVAB® Influenza Treatment Description
RAPIVAB® (peramivir injection) is an influenza virus neuraminidase inhibitor. Neuraminidase inhibitors interfere with the release of the influenza virus from infected host cells, a process that prevents infection of new host cells and thereby halts the spread of infection in the respiratory tract. The efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus.
As of August 25, 2022, about 50,000 doses of RAPIVAB have been delivered to the U.S. government over a five-year period.
BioCryst Pharmaceuticals, Inc. discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist, and an enzyme plays a key role in the biological pathway of the disease.
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RAPIVAB is approved in the USA (2014) and multiple global markets, with post-marketing commitments ongoing.
RAPIVAB® is approved in the USA for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days. Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and thus may reduce vaccine efficacy. The concurrent use of RAPIVAB with LAIV intranasal has not been evaluated.
RAPIVAB (peramivir injection) is approved in the USA and is administered via an intravenous infusion for a minimum of 15 minutes at recommended doses of 600 mg/kg for adults and adolescents and 12 mg/kg for pediatric patients ages six months to 12 years.
RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product. Severe allergic reactions have included anaphylaxis, erythema multiforme, and Stevens-Johnson Syndrome.
RAPIVAB Adverse Reactions
The most common adverse reaction in adults (18 years of age and older) was diarrhea (8% RAPIVAB vs 7% placebo).
August 25, 2022 - BioCryst Pharmaceuticals, Inc. announced that the U.S. Department of Health and Human Services exercised its option to purchase an additional 10,000 doses of the antiviral influenza therapy, RAPIVAB® (peramivir injection), for approximately $7 million. The order is the final of five purchase options from a $34.7 million contract (Contract No. 75D301-18-C-02984) the Centers for Disease Control and Prevention awarded in 2018.
August 4, 2022 - BioCryst Pharmaceuticals, Inc. reported financial results for the second quarter that ended June 30, 2022, and provided a corporate update.
RAPIVAB Clinical Trials
Clinical Trial NCT02369159: A Phase 3, Randomized, Open-Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics, and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute Uncomplicated Influenza. This study will evaluate the safety, pharmacokinetics, and effectiveness of a single dose of IV peramivir compared to a standard 5-day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza. Two-thirds of the participants will receive peramivir, while one third will receive oseltamivir.
Clinical Trial NCT00705406: A Phase II, Multicenter, Randomized, Placebo-Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza. The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
Clinical Trial NCT00419263: Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza. Peramivir is a neuraminidase inhibitor that was previously shown to be effective in the treatment of human experimental influenza using an oral formulation. Parenteral formulations of peramivir (for intramuscular and intravenous injection) entered clinical development at the time of this Phase 2 study.
A series of Phase 1 studies in human volunteers was completed that provided safety and pharmacokinetic results that supported the initiation of this Phase 2 multinational, randomized, double-mask study that compared the antiviral efficacy and safety of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza.
Because of the unique pharmacokinetic and pharmacodynamic properties of peramivir - a long terminal half-life in plasma and an extended duration of binding to the neuraminidase enzyme - subjects were randomized in a 1:1:1 ratio to receive a single dose of one of three treatments: peramivir 150 mg, peramivir 300 mg, and placebo.
The study drug was administered as one 2-mL intramuscular injection in each gluteal muscle (total of 4 mL, injected in divided doses). This multinational study was originally to be conducted at approximately 80 sites in the US and Canada. When enrollment during the North American influenza season of 2006-2007 did not achieve the target, the study was extended to sites in Australia, New Zealand, South Africa, and Hong Kong.