Luhan Pharmachem Co., Ltd.

Luhan pharmachem Co., Ltd. supplies Retigabine bulk active pharmaceutical ingredient (API) to the pharmaceutical industry. Our Retigabine is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product and up to date regulatory status of the manufacturing facility. We look forward to assisting you with your research and development projects.

What is Retigabine?

Retigabine is a neuronal potassium channel opener being developed as a first-in-class antiepileptic drug (AED) and is currently being studied in Phase 3 trials as an adjunctive treatment for partial-onset seizures in adult patients with refractory epilepsy

Ongoing Clinical Trials

Retigabine (Epilepsy)

Valeant Pharmaceuticals announced the publication of Phase 2 data for retigabine, click a first-in-class neuronal potassium channel opener, in Neurology, a leading independent, scientific journal (Read the press release). The authors concluded that retigabine was efficacious with a demonstrated reduction in monthly seizure rates in this study.

In addition, RESTORE (Retigabine Efficacy and Safety Trial for partial onset Epilepsy) trials are two Phase 3 trials (RESTORE1 & RESTORE2) designed to determine the efficacy and safety of retigabine used as adjunctive therapy in refractory epilepsy patients with partial-onset seizures. These Phase 3 studies are a randomized, double-blind, placebo-controlled, multi-center, parallel-group studies to assess the efficacy and safety of retigabine.

Valeant Pharmaceuticals plans to submit the NDA/MAA for Retigabine IR (Epilepsy) in the middle of 2008.

Valeant is also in the process of evaluating retigabine as a sustained release formulation.

Retigabine IR (Pain)

Valeant Pharmaceuticals has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for retigabine in the treatment of pain associated with post-herpetic neuralgia.

Valeant posts protocol information for all ongoing Phase 2, 3, and 4 trials to the National Institutes of Health’s (NIH) ClinicalTrials.gov website. To learn more about the clinical trials that are under way or to find out if a study is enrolling patients in your area, please visit www.clinicaltrials.gov.

Retigabine (D-23,129) is a psychoactive drug and research chemical under development as a novel anticonvulsant agent. Its acts as a neuronal KCNQ/Kv7 potassium channel opener, a mechanism of action completely different from those of presently marketed antiepileptics.

Retigabine is currently in phase III clinical trials as an adjunctive treatment for partial-onset seizures in adult patients with refractory epilepsy.

Disclaimer:

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.