GlaxoSmithKline and Valeant announce US FDA approval of Potiga™ (ezogabine)

GlaxoSmithKlineGlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Potiga™ (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

"We are so pleased to reach such an important milestone with the US approval of Potiga by the FDA," stated Susan Hall, PhD, head of research and development at Valeant. "We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications."

FDA has recommended that ezogabine be scheduled as a controlled substance under the Controlled Substances Act (CSA). Finalclassification is still under review by the Federal Drug Enforcement Administration (DEA) and ezogabine will not be available until this process is complete.

Ezogabine is expected to be available in U.S. pharmacies by the end of the year.

The efficacy of ezogabine as adjunctive therapy in partial onset seizures was established in three controlled clinical studies involving 1,239 adult patients. The primary endpoint was percent change in seizure frequency from baseline in the double-blind treatment phase.

FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) will be necessary for ezogabine, with the goal of informing healthcare professionals of the risk of urinary retention and the symptoms of acute urinary retention. Ezogabine caused urinary retention in clinical trials. Urinary retention was reported as an adverse event in 29 out of 1,365 (approximately 2%) patients treated with ezogabine. In all studies of patients with partial-onset seizures, including open-label studies, five patients required catheterization (four on ezogabine and one on placebo).

In three controlled clinical studies, 25% of patients receiving ezogabine (199/813) and 11% of patients receiving placebo (45/427) discontinued treatment because of treatment-emergent adverse reactions.

The most frequently reported adverse reactions in patients receiving ezogabine vs placebo (≥4% and occurring approximately twice the placebo rate) were dizziness (23% vs 9%), somnolence (22% vs 12%), fatigue (15% vs 6%), confusional state (9% vs 3%), vertigo (8% vs 2%), tremor (8% vs 3%), abnormal coordination (7% vs 3%), diplopia (7% vs 2%), disturbance in attention (6% vs <1%), memory impairment (6% vs 3%), asthenia (5% vs 2%), blurred vision (5% vs 2%), gait disturbance (4% vs 1%), aphasia (4% vs <1%), dysarthria (4% vs <1%), and balance disorder (4% vs <1%).

Outside of the US, ezogabine is known as retigabine (brand name Trobalt™), and received marketing authorization in the European Union (EU) on March 28th 2011.

GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

About Valeant - Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.

Most Popular Now

SK bioscience and GSK start Phase 3 trial of adjuv…

SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination wit...

Blood vessels produce growth factor that promotes …

Blood vessels supply tumors with nutrients and, on the other hand, enable cancer cells to spread throughout the body. The settlement of circulating tumor cells in a dista...

No serious health effects linked to mRNA COVID-19 …

Federal and Kaiser Permanente researchers combing the health records of 6.2 million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 v...

First-in-human clinical trial for a vaccine to tre…

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by resear...

New study examines 'Achilles heel' of cancer tumou…

Researchers at the University of British Columbia's faculty of medicine and BC Cancer Research Institute have uncovered a weakness in a key enzyme that solid tumour cance...

AI algorithm solves structural biology challenges

Determining the 3D shapes of biological molecules is one of the hardest problems in modern biology and medical discovery. Companies and research institutions often spend ...

A drug costing less than €2 a day helps in the tre…

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. This is the finding of a study by investigators at th...

Sandoz strengthens pipeline by entering into agree…

Sandoz, a Novartis division, today announced that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706). B...

Pfizer and BioNTech submit a variation to EMA with…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Condition...

Rheumatoid arthritis treated with implanted cells …

With a goal of developing rheumatoid arthritis therapies with minimal side effects, researchers at Washington University School of Medicine in St. Louis have genetically ...

One in three Americans had COVID-19 by the end of …

A new study published in the journal Nature estimates that 103 million Americans, or 31 percent of the U.S. population, had been infected with SARS-CoV-2 by the end of 20...

NIH scientists build a cellular blueprint of multi…

Chronic lesions with inflamed rims, or "smoldering" plaques, in the brains of people with multiple sclerosis (MS) have been linked to more aggressive and disabling forms ...