European regulators approve new Parkinson's drug to smooth motor fluctuations

The Committee for Medicinal Products for Human Use adopted a positive opinion on June 25 for Hopledo, a modified-release levodopa-carbidopa capsule for adults with Parkinson's disease and moderate-to-severe motor fluctuations who have not been adequately stabilized on standard oral levodopa and dopa decarboxylase inhibitor regimens.

One dose can work quickly, then wear off before the next dose is due. That leads to unstable drug levels, delayed "on" responses and dyskinesias, leaving people cycling between periods of better control and periods when symptoms return or intensify. Hopledo combines immediate-release granules with extended-release beads that use sustained-release, mucoadhesive and enteric coatings to prolong delivery in the gut. The capsule comes in four strengths: 140 mg/35 mg, 210 mg/52.5 mg, 280 mg/70 mg and 350 mg/87.5 mg.

Off time is the period when medication effects wear off and symptoms return or worsen between doses, sometimes gradually and sometimes as a sudden switch. That kind of unpredictability can affect walking, speaking, eating and basic mobility, especially as Parkinson's progresses and oral dosing becomes less reliable. Levodopa has remained the cornerstone of symptomatic treatment since the 1960s, but treatment-related complications such as wearing off and dyskinesia become more common over time.

About 40% of patients develop motor fluctuations after four to six years of levodopa therapy, and nearly all patients experience them over longer disease duration. Continuous subcutaneous levodopa-carbidopa infusion is another option for advanced Parkinson's disease with poorly controlled motor fluctuations.

Zambon S.p.A. is the applicant for Hopledo, and the June 25 opinion was only scientific advice. The European Commission still has to decide whether to grant EU-wide marketing authorization, which will determine whether the product reaches patients across the bloc.