Epilepsy

Epilepsy is a neurological condition that makes people susceptible to seizures. It is a common CNS disorder that affects 2.7 million people in the United States, with 181,000 new cases diagnosed each year (218). Epilepsy

Figure 7 The DepoFoam™ drug delivery system. Drug is encapsulated in microscopic, spherical particles composed of hundreds of non-concentric aqueous chambers that are separated by bilayer lipid membranes. Drug release from a DepoFoam formulation can be controlled by modification of the lipid components, aqueous excipients and manufacturing process. The DepoFoam system provides either local site or systemic delivery. Source: From Ref. 216.

Figure 7 The DepoFoam™ drug delivery system. Drug is encapsulated in microscopic, spherical particles composed of hundreds of non-concentric aqueous chambers that are separated by bilayer lipid membranes. Drug release from a DepoFoam formulation can be controlled by modification of the lipid components, aqueous excipients and manufacturing process. The DepoFoam system provides either local site or systemic delivery. Source: From Ref. 216.

accounts for annual healthcare costs of $12.5 billion. Epilepsy is typically treated with medications to prevent and/or control seizures. Accordingly, there are a number of products on the market that can be administered orally (including controlled release formulations) and parenterally (including fosphenytoin, described previously).

While medications are generally effective in the majority of patients, breakthrough seizures can occur. The term refers to seizure activity experienced by a patient with epilepsy, on a stable regimen of anti-epileptic drugs. Breakthrough seizures are intermittent and periodic episodes of markedly increased seizure activity. Treatment guidelines indicate acute seizure treatment within 5-10 min to avoid an increased risk of life-threatening complications (218). For patients, this typically means emergency treatment in a medical center. However, a rapid acting anti-convulsant formulation has been developed that offers at-home treatment for select patients who experience bouts of increased seizure activity.

Diazepam rectal gel (DIASTAT® AcuDial™) is a novel formulation approved by the US FDA to control bouts of increased seizure activity for refractory patients (both adults and children) with epilepsy on stable regimens of antiepilepsy medications. The formulation is packaged in pre-filled syringes that are designed to deliver diazepam gel rectally in patients. The formulation is stable at room temperature, making it a convenient delivery system (219,220).

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