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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 being developed for the management of seizures, specifically for patients with refractory epilepsy who require intermittent medical intervention for acute repetitive seizures. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Vanquix Auto-Injector contains diazepam, a benzodiazepine that enhances the effect of the neurotransmitter gamma-aminobutyric acid (GABA) at GABA-A receptors, producing a calming effect on the brain and helping to stop or reduce seizure activity. This mechanism is well-established for the acute treatment of seizures.
Vanquix Auto-Injector is being developed by Pfizer, Inc., a biopharmaceutical company publicly traded under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of seizures.
Vanquix Auto-Injector is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
Vanquix Auto-Injector has been studied in one completed Phase 3 clinical trial, identified as NCT00319501. This randomized, double-blind, placebo-controlled trial enrolled 234 participants with refractory epilepsy and acute repetitive seizures, conducted in the United States with participants aged 2 years and older.
Vanquix Auto-Injector is a formulation of diazepam, a well-known benzodiazepine medication used to treat seizures. The auto-injector device is designed to deliver diazepam in a specific way, but the active pharmaceutical ingredient is diazepam. It is being developed for acute repetitive seizures in epilepsy patients.