The US Food and Drug Administration has approved the first oral liquid suspension formulation of the antiepileptic drug zonisamide (Zonisade 100 mg/5 mL), as adjunctive therapy for partial seizures in adults and teens aged 16 years or older with epilepsy.
Zonisade “offers healthcare providers an important new treatment option for their patients with epilepsy,” Richard Blackburn, CEO of Azurity Pharmaceuticals, said in a news release announcing approval of the new formulation.
Three double-blind, placebo-controlled, multicenter clinical trials have demonstrated the efficacy and tolerability of zonisamide in adults and teens, the company noted in the release.
Zonisamide capsules (Zonegran) were first approved in the United States in 2000 and are now available as generics. The newly approved zonisade oral suspension should be administered once or twice daily, with or without food.
The recommended initial dose is 100 mg/d and may be increased by 100 mg/d every 2 weeks, on the basis of clinical response and tolerability, up to 400 mg/d, according to the product label.
Healthcare providers continue to seek “reliable formulations of medicines that may reduce the epilepsy patient and caregiver burden and help improve treatment adherence,” Jim Wheless, MD, chief of Pediatric Neurology, University of Tennessee Health Science Center, Memphis, said in the release.
“Zonisade addresses an important unmet need in patients who have difficulty swallowing or who are unable or unwilling to take tablets,” Wheless added.
Beth Dean, CEO of CURE Epilepsy, noted in the release that delivering new formulations “is important to help ensure diverse epilepsy populations can access the medication for management of their epilepsy” through greater dosing flexibility and customization.
“The FDA approval and availability of Zonisade is a welcomed advancement for patients and their families who may be seeking a liquid formulation alternative to treat epilepsy,” Dean said.