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Efficacy & Safety of DIASTAT® AcuDial™ (diazepam rectal gel)

Proven efficacy with the freedom of at-home administration

Rapid onset of action, begins working within 15 minutes.1

Rectal administration of diazepam is significantly faster than IM, tablet, and suppository and allows for rapid absorption without the danger of aspiration inherent in oral/buccal administration.2


* This study was conducted with diazepam solution, not diazepam gel.
  • 62% of patients treated with DIASTAT remained seizure free during observation period versus 20% of placebo patients in a pivotal trial3
  • 71% of patients in clinical trials remained seizure free for 12 hours after DIASTAT4
  • In a pivotal trial, no patients receiving Diastat required emergency medical care vs. 13% in the placebo group5
  • 82% of patients in a Diastat clinical trial were assessed by their caregivers as better versus 33% of placebo treated patients (p<0.0001).3

DIASTAT AcuDial offers uncompromised safety

In pivotal trials with DIASTAT, the most frequent adverse event reported was somnolence (23%). Less frequent adverse events reported were dizziness, headache, pain, abdominal pain, nervousness, vasodilation, diarrhea, ataxia, euphora, incoordination, asthma, rhinitis, and rash (1%-5%).3

In pivotal trials, no events of respiratory depression were observed.
  • Some patients received up to 180% of the recommended dose.3
  • Two patients in the clinical studies received more than twice the target dose; no adverse events were reported.3

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References:
  1. Cloyd JC, Lalonde RL, Beniak TE, Novack GD. A single-blind, crossover comparison of the pharmacokinetics and cognitive effects of a new diazepam rectal gel with intravenous diazepam. Epilepsia. 1998;39:520-526.
  2. Moolenaar F, Bakker S, Visser J, Huizinga T. Biopharmaceutics of rectal administration of drugs in man IX. Comparative biopharmaceutics of diazepam after single rectal, oral, intramuscular and intravenous administration in man. Int J Pharmaceut. 1980;5:127-137.
  3. DIASTAT AcuDial package insert. Aliso Viejo,Calif: Valeant Pharmaceuticals NA; Nov 2006.
  4. Cereghino J, Cloyd J, Kuzniecky R; for the North American Diastat Study Group. Rectal Diazepam Gel for Treatment of Acute Repetitive Seizures in Adults. Arch Neurol. 2002; 59: 1915-1920.
  5. Dreifuss FE,Rosman NP, Cloyd JC, et al. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med.1998;338:1869-1875.
 
IMPORTANT SAFETY INFORMATION

DIASTAT® AcuDial™ (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity for patients 2 years and older.

In clinical trials with DIASTAT®, the most frequent side effect was somnolence (23%). Less frequent adverse events reported were dizziness, headache, pain, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis (1%-5%). Please see full DIASTAT AcuDial Prescribing Information.