Summary:
Diazepam, the active ingredient of VALTOCO® (diazepam nasal spray), is a benzodiazepine anticonvulsant. VALTOCO® is for intranasal use only and is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age or older.
Qualified Participants Must:
• Healthy males and females according to the assessment of the investigator, based on a complete medical history and physical exam.
•
Between the ages of 18-55
•
Minimum body weight of 112lbs and a BMI of 18.5-29.9
•
Female subjects must meet at least one of the following criterion:
- Have used and agree to continue to use a reliable method of contraception (e.g., condom with diaphragm or cap, IUD, hormonal contraceptives) for at least 30 days before initial dosing and for at least 30 days following completion of the study.
- Surgically sterile (bilateral oophorectomy or hysterectomy, bilateral tubal ligation at least 3 months before initial dosing or Essure®
• device placement before the year 2018).
- Naturally postmenopausal (no menses) for at least 1 year before initial dosing
Qualified Participants May Receive:
Compensation for participating up to $1,250 over the study length of 3 days/ 2 nights.