Impax receives European Commission marketing authorization for Numient modified-release capsules for the symptomatic treatment of adults with Parkinson's disease

The company’s first branded drug approval outside of the US.

"We are pleased that Numient was approved by the EC as this not only showcases our R&D capabilities outside the US but is an additional positive review of our quality systems by another regulatory authority," said Fred Wilkinson, President and CEO of Impax. "Numient addresses one of the most significant unmet needs for patients living with this disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled."

"This is our first branded drug approved for commercialization outside the US and we are in active discussions with potential partners to support the commercialization of Numient in Europe and the rest of the world. We are analysing the options that will help facilitate the introduction of this product into the global market," concluded Mr Wilkinson.

The EC decision is based on results from three Phase III controlled clinical studies which assessed the safety and efficacy of Numient in patients with early (levodopa-naive) and advanced Parkinson's disease in the US and in Europe.