Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Peramivir is an investigational small molecule being developed for the treatment of influenza, including acute uncomplicated human influenza and seasonal influenza. It is administered intravenously and is being studied in patients with influenza, including those with serious or potentially life-threatening infections.
Peramivir is a neuraminidase inhibitor, a class of antiviral drugs that work by blocking the neuraminidase enzyme on the surface of influenza viruses. This prevents the virus from replicating and spreading to other cells, helping to reduce the duration and severity of influenza symptoms.
Peramivir is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol BCRX. The company is conducting clinical trials to evaluate the safety and efficacy of Peramivir for the treatment of influenza.
Peramivir is in Phase 2 clinical development for the treatment of influenza. While some completed trials have been designated as Phase 3, the overall development program is currently at the Phase 2 stage, and Peramivir remains an investigational drug that has not been approved by regulatory authorities.
Peramivir has been studied in several completed clinical trials, including NCT00419263, which evaluated its efficacy and safety in 344 subjects with uncomplicated acute influenza, and NCT00453999, which assessed its use in 137 adults with acute serious or potentially life-threatening influenza. Other trials include NCT02635724 and NCT02665351.
Peramivir is also known by the brand name Rapivab. It is a neuraminidase inhibitor used to treat influenza, and it is administered intravenously. The drug has been studied in multiple clinical trials for various influenza indications, including uncomplicated and serious infections.