Azurity’s Zonisade Receives the US FDA’s Approval for Partial Seizures in Adults and Pediatric Patients with Epilepsy
Shots:
- The US FDA has approved Zonisade (100mg/5mL) for partial seizures in adults & pediatric patients aged ≥16yrs. with epilepsy who have difficulty in swallowing or are unable to take tablets
- In the three trials, the efficacy & tolerability of zonisamide has been evaluated. The first study showed significant treatment differences across 100/200/400mg dose levels while in 2nd & 3rd studies, significant differences across 400mg to 600mg dose with no apparent difference b/w qd & BID
- In an additional analysis of the first 4wks. of treatment, significant differences from PBO b/w 100 & 400mg dose. Zonisade marks the first US FDA-approved oral liquid formulation of zonisamide that helps to reduce the burden & improve treatment adherence
Ref: AZURITY PHARMACEUTICALS | Image: AZURITY PHARMACEUTICALS
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