The Food and Drug Administration (FDA) has approved Zonisade (zonisamide oral suspension) as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.

Zonisade is an oral suspension containing 100mg/5mL of zonisamide as a strawberry flavored liquid in a 150mL bottle. The liquid formulation should be administered using an accurate measuring device. Any unused portion should be discarded 30 days after first opening the bottle.

“Zonisade is the first and only FDA-approved oral liquid formulation of zonisamide, and it offers health care providers an important new treatment option for their patients with epilepsy,” said Richard Blackburn, CEO of Azurity Pharmaceuticals.

The approval was based on a bioavailability study comparing the efficacy of Zonisade oral suspension to zonisamide capsules in healthy individuals.

The most common adverse reactions associated with Zonisade include somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration. The use of Zonisade is contraindicated in patients with hypersensitivity to sulfonamides or zonisamide.

References

  1. Azurity Pharmaceuticals, Inc. announces FDA approval of Zonisade™ (zonisamide oral suspension). News release. Azurity Pharmaceuticals, Inc. Accessed July 18, 2022. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-zonisade-zonisamide-oral-suspension-301587834.html
  2. Zonisade. Package insert. Azurity Pharmaceuticals, Inc.; 2022. Accessed July 18, 2022. https://azurity.com/wp-content/uploads/2022/07/ZONISADE-Prescribing-Information-rev-07.22.pdf