Tag Archives: partial-onset seizures

October, 2018

1 October
Eisai Announces FDA Approval of Fycompa in Patients 4 Years and Older for Treatment of Partial-Onset Seizures

WOODCLIFF LAKE, N.J., Sept. 28, 2018 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug FYCOMPA® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized …
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18 May
Pfizer’s Lyrica Oral Solution CV Meets Primary Endpoint in Late-Stage Trial in Pediatric Epilepsy

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with …
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28 October
Eisai Initiates Two Phase 3 Trials with Fycompa in Children with Epilepsy

WOODCLIFF LAKE, N.J., Oct. 28, 2016 /PRNewswire/ — Eisai Inc. announced today the initiation of two multi-center, global Phase 3 clinical trials assessing FYCOMPA® (perampanel) CIII in two different patient populations: patients age 2 years and above with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS) (Study 338), a rare …
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10 October
FDA Approves Lundbeck’s Carnexiv Injection as Intravenous Option for Patients with Certain Seizure Types

DEERFIELD, Ill.–(BUSINESS WIRE)–Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has approved Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will …
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2 May
FDA Approves Oral Suspension Formulation of Eisai’s Fycompa

WOODCLIFF LAKE, N.J., May 2, 2016 /PRNewswire/ — Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA® (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in …
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