FDA Approves Diastat AcuDial for At-Home Treatment of Emergency Seizures

By Adam Modzelesky
EpilepsyUSA staff
Posted: November 16, 2005

The Food and Drug Administration approved Diastat AcuDial for treating emergency seizures at home in late September. Diastat AcuDial is an exclusive proprietary drug delivery system that gives physicians and pharmacists greater flexibility in adapting dosages based on individual patients' needs. It will be available in pharmacies nationwide in early October 2005.

The new treatment has been met with positive opinions from epilepsy experts.

"Diastat AcuDial permits doctors to "fine-tune" the amount of medication given to each patient," said Gregory L. Barkley, chair of the Epilepsy Foundation's professional advisory board.

The Diastat AcuDial system incorporates the ability to dial, set and lock specific doses in two configurations delivering doses ranging from five to 20 milligrams. It is also easily administered by non-medical caregivers. No refrigeration or special handling is required, so it can be stored in the home, office or taken when traveling.

"When a patient begins to have prolonged or recurrent seizures outside of their normal patterns, it's a medical emergency that needs to be treated immediately," said James W. Wheless, M.D., professor and chief of pediatric neurology at the University of Tennessee Health Sciences Center. "In the United States, the amount of time that typically elapses between the onset of a seizure and a patient receiving treatment at a hospital can exceed one hour. That's too long for this type of emergency. AcuDial is a safe, effective treatment, which is a significant patient advantage."

Diastat AcuDial is produced by Valeant Pharmaceuticals.