Orion’s drug Stalevo fails to produce sufficient trial data

Orion’s drug Stalevo has not produced sufficient data during clinical trials for it to be approved by the European Union.

An assessment by Rapporteurs indicated that the research was not adequate for the treatment to be authorised and the pharmaceutical company was unable to provide additional material to support its application in the given time frame.

As a result, Orion has now withdrawn its application for extending the indication of the medication, which is aimed at aiding adult patients with Parkinson’s disease.

It was also intended for use in end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor treatment.

The European Medicines Agency had been reviewing the Stalevo application since April last year, based on the favourable results from a study conducted by the marketing partner for the product, Novartis.

Last week, Orion also announced it had transferred 44,806 of its B-shares to employees as part of an incentive scheme for staff.

Since the transaction, the firm now holds 280,030 of the units.

The business employs around 3,100 people and its headquarters are in Espoo, Finland.