Partial-onset Seizures

• FDA approval · 2015-03-10
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, authorizing an extended-release formulation for use in epile…

• CLINICAL_TRIALS trial_result · 2015-03-02
  Clinical Trial Update: A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures [Phase 2]

  A Phase 2 cognition study of levetiracetam in children with partial-onset seizures has completed (19-week evaluation).

• CLINICAL_TRIALS trial_result · 2015-02-11
  Clinical Trial Update: A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures [Phase 3]

  A double-blind, confirmatory Phase 3 trial of levetiracetam in patients with partial-onset seizures has completed.

• CLINICAL_TRIALS trial_result · 2015-02-09
  Clinical Trial Update: A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures [Phase 3]

  Phase 3 trial evaluating adjunctive lacosamide in adults with partial-onset seizures has completed and results were posted in 2015.

• FDA approval · 2015-02-04
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for oxcarbazepine submitted by Amneal Pharmaceuticals LLC, expanding the regulatory authorizatio…

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• FDA approval · 2015-01-20
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for oxcarbazepine from Glenmark Pharmaceuticals Inc., USA (ANDA 077802).

• CLINICAL_TRIALS trial_result · 2014-10-24
  Clinical Trial Update: Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures [Phase 2]

  Phase 2 study evaluating the cognitive effects of eslicarbazepine acetate in children with partial-onset seizures; results have been posted.

• CLINICAL_TRIALS trial_result · 2014-10-13
  Clinical Trial Update: An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy [Phase 3]

  Phase 3 open-label study assessing levetiracetam monotherapy in patients with newly diagnosed focal epilepsy.

• FDA approval · 2014-09-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Civica, Inc.)

  FDA approved a Civica, Inc. supplemental application for Levetiracetam, approving changes to the generic product. The product is indicated f…

• CLINICAL_TRIALS trial_result · 2014-09-08
  Clinical Trial Update: Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures [Phase 3]

  A Phase 3 trial evaluating two doses of immediate-release retigabine (900 mg/day and 600 mg/day) as adjunctive therapy in adult Asian subjec…

• FDA approval · 2014-08-29
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., indicating an approval of a supplement to the drug’s…

• FDA approval · 2014-08-12
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) by UCB, Inc., authorizing changes to the labeling and/or addition of indicat…

• FDA approval · 2014-08-12
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc. The action updates the product labeling with the new …

• FDA approval · 2014-08-07
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc., potentially expanding labeling or indications.

• FDA approval · 2014-06-04
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA Supplemental Application approval for VIMPAT (lacosamide) by UCB, Inc.

• FDA approval · 2014-05-08
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Trileptal (oxcarbazepine) submitted by Novartis Pharmaceuticals Corporation, resulting in ch…

• CLINICAL_TRIALS trial_result · 2014-05-07
  Clinical Trial Update: Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures [Phase 3]

  Phase 3 study evaluating USL255 for refractory partial-onset seizures has completed. Results were posted in 2014.

• CLINICAL_TRIALS trial_result · 2014-05-01
  Clinical Trial Update: Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures [Phase 4]

  A Phase 4 trial evaluated lacosamide as the first add-on antiseizure medication for patients with partial-onset seizures; results were poste…

• CLINICAL_TRIALS trial_result · 2014-04-23
  Clinical Trial Update: Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures [Phase 3]

  Phase 3 trial results evaluate converting to lacosamide monotherapy for partial-onset seizures, reporting on efficacy and safety.

• CLINICAL_TRIALS trial_result · 2014-03-26
  Clinical Trial Update: Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures [Phase 3]

  Phase 3 study evaluating adjunctive topiramate in infants aged 1–24 months for partial-onset seizures has completed.

• CLINICAL_TRIALS trial_result · 2014-03-26
  Clinical Trial Update: Dose-Optimization, Adjunctive Treatment Study of Ezogabine/Retigabine Immediate Release in Partial-onset Seizures [Phase 4]

  Phase 4 dose-optimization study of ezogabine/retigabine IR as adjunctive treatment in partial-onset seizures was terminated; results posted …

• CLINICAL_TRIALS trial_result · 2014-01-24
  Clinical Trial Update: Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures [Phase 2, Phase 3]

  Phase 2/3 trial evaluating the efficacy, safety and tolerability of TRI476 (oxcarbazepine) in children with inadequately controlled partial …

• FDA approval · 2014-01-16
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc.

• CLINICAL_TRIALS trial_result · 2013-12-03
  Clinical Trial Update: Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS [Phase 3]

  A Phase 3 double-blind, placebo-controlled trial evaluating levetiracetam in adults with partial-onset seizures has completed.

• FDA approval · 2013-11-08
  FDA Approved: APTIOM — Original Application (Sumitomo Pharma America, Inc.)

  FDA approved APTIOM (eslicarbazepine acetate) from Sumitomo Pharma America as an original NDA for use in adults with partial-onset seizures …