On July 18, 2022, Azurity Pharmaceuticals announced that the FDA approved their oral liquid formulation of zonisamide 100 mg/5 mL for the treatment of adults and patients aged 16 years and older. More individual needs are met with the addition of a commercially available liquid formulation to help better manage their epileptic state.
Recurrent seizures are the hallmark signs of epilepsy, a neurological disorder. Sudden behavioral changes are observed as a result of abnormal brain activity. This disease state has a wide range of symptoms and can affect both males and females of all ages and races. A confirmatory diagnosis is made when a patient has at least two unprovoked seizures that are at least 24 hours apart. Antiepileptic drugs are a type of medication used to treat this disease state, and zonisamide is one of them.
Zonisamide is a sulfonamide antiepileptic medication that is approved as an adjunctive therapy to treat partial seizures in adults and adolescents aged 16 years and older. The initial dose for adults is 100 mg to 200 mg daily, with a weight-based consideration of 2 to 4 mg/kg/day for children. Dizziness, fatigue, confusion, and weight loss are all common side effects of this medication.
In three double-blind, placebo-controlled, multicenter clinical trials, zonisamide was found to be effective and tolerable. The first study looked at patients with partial-onset seizures and found that zonisamide treatment with a daily dose range of 100 mg to 400 mg was effective. The second and third studies yielded similar results, with both demonstrating statistical significance when zonisamide was compared with a placebo.
Tablets and capsules were the only commercially available dosage forms prior to this newly approved formulation. This restricted patients’ use based on their needs, particularly if they had restrictions such as difficulty swallowing, taste, allergies, etc. A liquid suspension—a heterogeneous mixture of two or more substances—was one of the more common formulations prepared through extemporaneous compounding. The active pharmaceutical ingredient, a suspending vehicle such as Oral-Plus, and a flavoring agent such as Oral-Sweet, were all included in this formulation.
The capsule’s contents are pulverized to produce a finely grained powder. Small amounts of this powder are geometrically mixed with the vehicle to create a homogeneous paste. The compounded preparation is finished after it has been calibrated to the appropriate volume by adding sufficient amounts of the vehicle. Once prepared, a common counseling point for patients is to shake well prior to use.
Although compounding was an option for meeting individual needs, there are several factors that could prevent or delay a patient’s access to it, such as insurance coverage. As a result—now that this new formulation is commercially available—a broader range of patients can be accommodated.
This new treatment formulation is easily accessible for proper management of a diverse epileptic population. With an oral suspension, more flexibility and customization are available to best tailor to the patient’s needs without the need for extemporaneous compounding.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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