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Also known as Vanquix Auto-Injector (Diazepam Injection)
Vanquix Auto-Injector · 1 trial · 5 indications
An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.
An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). |
| Diazepam | EXPERIMENTAL | During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, as a deep intramuscular injection in the mid to outer thigh. Additional doses were permissible during the Open-label Period. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Intramuscular autoinjector; administered at onset of an episode |
| Vanquix Auto-Injector (Diazepam Injection) | DRUG | Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode |
Key Inclusion Criteria For Patient: * Older than 2 years of age and between 6 and 136 kg body weight * Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring intermittent medical intervention to control episodes of acute repetiti...
Vanquix Auto-Injector is an investigational small molecule therapy being developed by Pfizer, Inc. (PFE) for the treatment of seizures. It is a diazepam injection delivered through an auto-injector device, studied in patients who require intermittent medical intervention for acute repetitive seizures.
Vanquix Auto-Injector is being developed for the management of seizures, including acute repetitive seizures in patients with refractory epilepsy. The Phase 3 study enrolled patients with partial, complex partial, and generalized epilepsy who needed intermittent medical intervention for seizure episodes.
Vanquix Auto-Injector is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating the diazepam auto-injector for seizure management.
Vanquix Auto-Injector is in Phase 3 development. It is investigational and has not been approved by the FDA. The Phase 3 trial has been completed, and no trials are currently active.
Vanquix Auto-Injector was evaluated in one completed Phase 3 trial, NCT00319501, titled Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures. The randomized, double-blind, placebo-controlled study enrolled 234 participants in the United States, including patients aged 2 years and older.
Vanquix Auto-Injector is also known as Vanquix Auto-Injector (Diazepam Injection). It is a diazepam injection formulated for delivery through an auto-injector device, and it is being developed by Pfizer for seizure management.