Amneal Pharmaceuticals (AMRX) and Zambon's therapy Hopledo has received a positive opinion by the Committee for Medicinal Products for Human Use recommending European Medicines Agency marketing authorization for the treatment of adult patients with Parkinson's disease and moderate to severe motor fluctuations, the companies said Monday.

The specific indication is for those patients who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments, the companies said

The recommendation was based on data from a 506-patient phase 3 in which Hopledo showed a "significant" improvement over immediate-release levodopa/carbidopa with fewer daily doses and with a comparable safety profile, the companies said.

If approved, the companies expect to make Hopledo available beginning in October, the companies said.