Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days. RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than two days. FDA label
Also known as intravenous neuraminidase inhibitor, Rapivab
Peramivir · 7 trials · 9 indications
Safety was evaluated through assessment of Adverse Events (AEs).
Safety evaluation included assessment of Adverse Events (AEs).
The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
5-10 days
The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).
| Arm | Type | Description |
|---|---|---|
| Peramivir | EXPERIMENTAL | Single dose 600 mg IV injection |
| Peramivir (IV) | EXPERIMENTAL | Subjects randomized to peramivir will receive an age appropriate single dose, diluted to a maximum volume of 100 mL in normal saline, administered as a short intravenous infusion over a minimum of 15 minutes. * Subjects ≥12 years will receive a dose of 600 mg. * Subjects \<12 years will receive a dose of 12 mg/kg (to a maximum dose of 600 mg). * Subjects \< 6 months will receive a dose of 8 mg/kg. |
| Oseltamivir | ACTIVE_COMPARATOR | Subjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days. * Subjects ≥ 13 years will receive a 75mg dose administered as a capsule or oral suspension (twice daily for 5 days). * Subjects \< 13 years of age will receive a weight-based dose administered as a capsule or oral suspension (twice daily for 5 days). |
| Peramivir 300 mg | EXPERIMENTAL | Peramivir 300 mg twice daily |
| Peramivir 600 mg | EXPERIMENTAL | Peramivir 600 mg once daily |
| Peramivir 300mg Q12H | ACTIVE_COMPARATOR | Peramivir 300 mg, administered intravenously, twice daily (every 12 hours) |
| Peramivir 600mg Q24H | ACTIVE_COMPARATOR | Peramivir 600 mg, administered intravenously, once daily (every 24 hrs) |
| Placebo | PLACEBO_COMPARATOR | Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection. |
| Arm 1: Peramivir 200 mg | EXPERIMENTAL | Peramivir 200 mg administered intravenously once daily for 5 days (5 doses) |
| Arm 2: Peramivir 400 mg | EXPERIMENTAL | Peramivir 400 mg administered intravenously once daily for 5 days (5 doses) |
| Arm 3: Oseltamivir | EXPERIMENTAL | Oseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses) |
| Peramivir 150 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Peramivir | DRUG | - |
| Oseltamivir | DRUG | - |
| Placebo | DRUG | Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection. |
| Peramivir 200 mg | DRUG | Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment |
| Peramivir 400 mg | DRUG | Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml) |
| Peramivir 150 mg | DRUG | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). |
| Peramivir 300 mg | DRUG | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
Inclusion Criteria: * A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at least one clinical sign or symptom consistent with acute influenza infection as listed below OR * Clinical signs and symptoms consistent with acute influenza infection consisting of an oral tem...
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Peramivir is an investigational small molecule antiviral being developed by BioCryst Pharmaceuticals for acute, uncomplicated human influenza, including seasonal influenza. It is given intravenously and has been studied in adults, elderly and higher risk subjects, and pediatric patients with uncomplicated influenza, as well as in hospitalized patients with influenza-associated lower respiratory tract infections.
Peramivir is being studied for the treatment of acute, uncomplicated human influenza and seasonal influenza. Clinical trials have enrolled adults, elderly and higher risk subjects, pediatric patients, and hospitalized patients with confirmed or suspected influenza or influenza-associated lower respiratory tract infections. It remains an investigational therapy rather than an approved product.
Peramivir is developed by BioCryst Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker BCRX. The company has sponsored the clinical program evaluating intravenous peramivir across adult, elderly, pediatric, and hospitalized influenza populations.
Peramivir is in clinical development and is not an approved product. Its program includes Phase 2 and Phase 3 studies, with the Phase 2 designation reflecting its current listed development stage. Five trials have been conducted in total, of which four are completed and none are currently active.
Peramivir has been evaluated in five registered trials, including NCT02665351 in adults hospitalized for influenza-associated lower respiratory tract infections, NCT02635724 in elderly and higher risk subjects, NCT02369159 versus oseltamivir in pediatric subjects, and NCT00957996 in hospitalized subjects with confirmed or suspected influenza. All four are completed.