Schwarz reveals results of “pivotal” restless legs drug trial

Schwarz Pharma, the German pharmaceutical company, has revealed positive new results for Rotigotine, a transdermal patch for the treatment of restless legs syndromes (RLS).

The multinational phase III trial – described by Schwarz as having the potential to be considered as a “pivotal” study – demonstrated that patients using the drug showed a statistically significant reduction in RLS symptoms compared to the placebo.

Some 458 patients with moderate to severe RLS were treated using either the placebo or a 2.25mg transdermal Rotigotine patch in a phase III trial. The drug achieved both of its primary endpoints, including an “absolute change” from the validated baseline set by the international RLS study group rating scale (IRLS).

Iris Loew-Friedrich, member of Schwarz’s executive board, remarked: “We are encouraged by the magnitude of the reduction of restless legs syndrome symptoms and the good tolerability, which patients experienced during the trial.”

She added that all of the doses tested achieved a statistically significant reduction of symptoms on the IRLS scale.

Last month, UCB, the Belgian pharmaceutical company, announced that it had made a successful 4.4 billion euro (2.95 billion pounds) bid for Schwarz. UCB claims that the German company represents a strong complementary fit in therapeutic and geographic terms, as well as creating a stronger product pipeline.