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Potiga (Ezogabine) - Summary

 
 



WARNING: RETINAL ABNORMALITIES AND POTENTIAL VISION LOSS

  • POTIGA can cause retinal abnormalities with funduscopic features similar to those seen in retinal pigment dystrophies, which are known to result in damage to the photoreceptors and vision loss.
  • Some patients with retinal abnormalities have been found to have abnormal visual acuity. It is not possible to determine whether POTIGA caused this decreased visual acuity, as baseline assessments are not available for these patients.
  • Approximately one third of the patients who had eye examinations performed after approximately 4 years of treatment were found to have retinal pigmentary abnormalities. An earlier onset cannot be ruled out, and it is possible that retinal abnormalities were present earlier in the course of exposure to POTIGA. The rate of progression of retinal abnormalities and their reversibility are unknown.
  • POTIGA should only be used in patients who have responded inadequately to several alternative treatments and for whom the benefits outweigh the potential risk of vision loss. Patients who fail to show substantial clinical benefit after adequate titration should be discontinued from POTIGA.
  • All patients taking POTIGA should have baseline and periodic (every 6 months) systematic visual monitoring by an ophthalmic professional. Testing should include visual acuity and dilated fundus photography. Additional testing may include fluorescein angiograms (FA), ocular coherence tomography (OCT), perimetry, and electroretinograms (ERG).
  • If retinal pigmentary abnormalities or vision changes are detected, POTIGA should be discontinued unless no other suitable treatment options are available and the benefits of treatment outweigh the potential risk of vision loss.
 

POTIGA SUMMARY

The chemical name of ezogabine is N-[2-amino-4-(4-fluorobenzylamino)-phenyl] carbamic acid ethyl ester, and it has the following structure.

POTIGA is a potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.
See all Potiga indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Potiga (Ezogabine)

Ezogabine: a novel antiepileptic as adjunctive therapy for partial onset seizures. [2010]
Ezogabine (retigabine) is a novel antiepileptic agent which primarily acts to stabilize neuronal potassium-gated ion channels.The most common adverse events, comprising dizziness, somnolence, headache and fatigue, were dose-related and affected the central nervous system.

Safety and tolerability of different titration rates of retigabine (ezogabine) in patients with partial-onset seizures. [2013]
Retigabine (RTG; international nonproprietary name)/ezogabine (EZG; US adopted name) is an antiepileptic drug (AED) that prolongs neuronal voltage-gated potassium-channel KCNQ2-5 (Kv 7.2-7.5) opening... Overall, the slow-titration rate appeared to be best tolerated and was used in further efficacy and safety studies with RTG/EZG.

Ezogabine: a novel antiepileptic for adjunctive treatment of partial-onset seizures. [2013]
Epilepsy is defined as a tendency toward recurrent seizures unprovoked by any systemic or acute neurologic insults...

Ezogabine (retigabine). [2011]
Ezogabine (Potiga; Valeant Pharmaceuticals/GlaxoSmithKline), a potassium channel opener, was approved in June 2011 by the U.S.

more studies >>

Clinical Trials Related to Potiga (Ezogabine)

Crossover Study to Evaluate the Pharmacokinetics of Ezogabine/Retigabine in Taiwanese Subjects [Completed]
The purpose of this study is to investigate the pharmacokinetics of single oral doses of ezogabine/retigabine and the primary metabolite (NAMR) in healthy male and female Taiwanese volunteers. Subjects will receive four separate doses of ezogabine/retigabine tablets: 50 mg, 100 mg, 200 mg and 400 mg administered once orally. Blood samples will be obtained at pre-defined timepoints over the duration of the study to determine the concentration of ezogabine/retigabine and NAMR. Safety assessments will include measurements of vital signs, collection of adverse events, clinical laboratory tests and the Columbia Suicide Severity Rating Scale.

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 [Terminated]
The immediate release (IR) formulation of retigabine has been shown to be superior to placebo as adjunctive therapy in 3 adequate and well-controlled studies in subjects with drug-resistant partial-onset seizures (POS) who had previously failed to respond to two or more antiepileptic drugs (AEDs) and were still having seizures despite current treatment with 1, 2, or 3 AEDs. However, of 1244 subjects randomly assigned to treatment in these 3 clinical studies, only 10 were Asian subjects and only 5 of these Asian subjects were randomly assigned to treatment with retigabine. Therefore, this Phase III study is being conducted to evaluate the efficacy, safety and tolerability, and health outcomes of retigabine, at doses of 900 mg/day and 600 mg/day, compared with placebo in adult Asian subjects with drug-resistant POS.

Clinical Trial of Ezogabine (Retigabine) in ALS Subjects [Not yet recruiting]
This study evaluates the effect of retigabine (600 mg/day, 900 mg/day, or placebo) on motor neuron activity in people with Amyotrophic Lateral Sclerosis (ALS). The total study duration is approximately 14 weeks. ALS subjects will take study drug for approximately 10 weeks.

Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study [Completed]

Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS [Terminated]
The purpose of this study is to evaluate the long-term safety and tolerability of retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset seizures (12 to < 18 years old) or Lennox-Gastaut Syndrome (12 to <30 years old) who have participated in a previous ("parent") study.

more trials >>

Reports of Suspected Potiga (Ezogabine) Side Effects

Convulsion (20)Epilepsy (16)Somnolence (7)Dizziness (7)Urinary Retention (7)Diarrhoea (7)Aphasia (6)Confusional State (5)Drug Ineffective (5)Loss of Consciousness (5)more >>


Page last updated: 2014-12-01

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