FDA Approves Zonisamide Oral Suspension as Adjunctive Therapy For Epilepsy

The FDA has approved zonisamide oral suspension (Zonisade; Eton Pharmaceuticals, Inc, Azurity Pharmaceuticals) as an adjunctive therapy for patients with epilepsy, 16 years of age and older), who suffer from partial seizures.

The oral liquid zonisamide formulation is the first and only of its kind.² The drug will be released by Eton Pharmaceuticals and the privately owned Azurity Pharmaceuticals, Inc, who formed a multi-product neurology oral solution partnership in February 2021 and plan on releasing other drugs in the future.¹

"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, in a press release.²

Following 3 double-blind, placebo-controlled, and multicenter clinical trials, zonisamide was found to be effective and tolerable. The newly approved drug will be prescribed at 1 to 2 doses daily.²

"Zonisade addresses an important unmet need in patients who have difficulty swallowing or who are unable or unwilling to take tablets," said Jim Wheless, MD, chair of Pediatric Neurology, University of Tennessee Health Science Center, in a press release.²

First used by Japan and Korea to treat seizures, zonisamide was FDA-approved as a treatment option in 2000.⁵ This will be the first liquid form of zonisamide oral suspension, according to the press release.^1,5

Globally, an estimated 65 million people suffer from epilepsy, which causes recurring, unprovoked seizures, and is the world’s fourth most common neurological disorder.⁴ Epilepsy comes with its own series of comorbities, such as learning disabilities, autism, anxiety, and depression.²

The safety of this drug for patients younger than 16 years of age has not yet been established.²

"Delivering new treatment formulations is [also] important to help ensure diverse epilepsy populations can access the medication for management of their epilepsy,” said CEO of CURE Epilepsy, Beth Dean, in a press release.²

References

1. Eton Pharmaceuticals Announces FDA Approval of ZONISADE™ (Zonisamide Oral Suspension). GlobeNewswire. News Release. July 18, 2022. Accessed July 18 2022. https://www.globenewswire.com/news-release/2022/07/18/2480941/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-ZONISADE-Zonisamide-Oral-Suspension.html
2. AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF ZONISADE™ (zonisamide oral suspension). Cision. News Release. July 18, 2022. Accessed July 18, 2022. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-zonisade-zonisamide-oral-suspension-301587834.html.
3. An old epilepsy med gets oral liquid formulation nod; PMV pairs up ASCO standout with Keytruda. Endpoints News. News Release. July 18, 2022. Accessed July 18, 2022. https://endpts.com/an-old-epilepsy-med-gets-oral-liquid-formulation-nod-pmv-pairs-up-asco-standout-with-keytruda/
4. What is Epilepsy? Epilepsy Foundation. Website. July 18, 2022. Accessed July 18, 2022. https://www.epilepsy.com/what-is-epilepsy
5. Zonisamide. Epilespy Foundation. Website. July 18, 2022. Accessed July 18, 2022. https://www.epilepsy.com/tools-resources/seizure-medication-list/zonisamide