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Home Industry News Valeant completes phase III retigabine epilepsy programme

Valeant completes phase III retigabine epilepsy programme

20th May 2008

Valeant has announced that it has successfully completed its phase III epilepsy programme for retigabine, with the Restore 2 trial validating the novel mechanism of action of the compound.

The trial showed the efficacy of both 600gm and 900mg doses of the drug, which builds upon earlier positive phase III study results for a 1,200mg dose of the compound.

Valeant plans to submit a marketing authorisation application with the European Medicines Evaluation Agency for the first-in-class neuronal potassium channel opener as an adjunctive treatment for adult patients with epilepsy with refractory partial onset seizures.

J Michael Pearson, chairman and chief executive officer of Valeant, said: ” We are extremely pleased with the efficacy and tolerability profile of retigabine as demonstrated in the Restore 2 study.”

He added that the positive results for the compound confirm the utility of selective potassium channel openers in this indication, with the company excited about the medical advance represented by the drug and the consequent commercial opportunity for the firm.

In February 2008, Valeant announced the results of the the Restore 1 study, where retigabine showed statistically significant results on its primary efficacy endpoints.

At the time, the company said that these data put Valeant at the head of the development of neuronal potassium channel openers for the treatment of central nervous system diseases including epilepsy.

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