A new, gel-based, delivery system containing a common benzodiazepine may provide a needed safety net for patients with epilepsy who are refractory to traditional mono- and combination pharmacotherapy and who experience bouts of increased seizure activity. Last month, Valeant Pharmaceuticals announced that it had received Food & Drug Administration approval to market Diastat AcuDial (diazepam rectal gel).

Diastat AcuDial represents an exclusive, proprietary drug delivery system that is the only FDA-approved, at-home therapy for the rapid and safe management of emergency epileptic seizures, claims Valeant. Diastat is intended for rectal administration in the management of selected, refractory epilepsy patients who are at least two years old. These patients are on stable regimens of antiepileptic drugs and require intermittent use of diazepam to control bouts of increased seizure activity.

According to a Valeant company spokesperson, a company pharmacist played a key role in the team approach used to develop this product: "A Pharm.D. on our professional advisory board was actively involved in our development as well as our educational initiatives with Diastat AcuDial."

Tips to Remember Diastat AcuDial

Diastat AcuDial is supplied as a twin pack of prefilled configurations: the 10-mg version (4.4-cm tip size) and the 20-mg formulation (6-cm tip size) provide the ability to dose from 5 mg to 10 mg, and 10 mg to 20 mg, respectively. According to the company spokesperson: "Diastat AcuDial will allow for more precise dosing [in 2.5-mg increments]. Stocking issues will be greatly resolved with pharmacists. Pharmacists will now dial and lock in the patients' dose.... Pharmacies, EMS, and hospital situations ... can deliver increased dosing capabilities to the patient, while only having to order two delivery systems instead of the previous five of the former Diastat."

According to the Epilepsy Foundation (www.epilepsyfoundation.org), there are more than 2.5 million people in the United States with epilepsy, up from 2.3 million in 1995. There are about 200,000 new cases of epilepsy diagnosed each year. The incidence is highest in children under the age of two and patients over 65. Some 45,000 children under 15 are diagnosed with the disease each year. In a majority of cases (70%), there is no apparent cause.

A study of 470 epilepsy patients, published in 2000 in the New England Journal of Medicine, indicated that 36% of patients studied were refractory to both monotherapy and combination therapy of standard antiepileptic medications.

Uncontrolled seizures in epileptic patients lead to a diminished quality of life, reflected in a lack of adequate seizure relief and attendant feelings of nervousness, depression, and lack of control. In addition, chronic, recurring uncontrolled seizures can lead to a variety of untoward events. Early and effective resolution of seizures is necessary to reduce the potential impact and severity of cognitive and memory impairment, vulnerability to depression, accidental injury, and even death in medication-resistant patients.

Diastat AcuDial has the potential to play a key role in reducing the risk of uncontrolled seizures in patients who do not live alone and who suffer from uncontrolled epileptic seizures, the company noted.

The Author is a writer based in New Jersey.