Drugmakers Zambon and Amneal Pharmaceuticals LLC have announced another step in making the drug, Hopledo (IPX203), an extended-release formulation of levodopa/carbidopa developed for adults with Parkinson’s disease who experience”motor fluctuations” (meaning their symptoms return as the effects of their medication wear off between doses), available to the people of Europe.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the extended-release medication, which is currently available in the United States as Crexnot. The committee reviewed the findings and found that the evidence from the clinical trials did indeed provide longer symptom relief for users who participated in the trials versus the standard-release levodopa/carbidopa in people with Parkinson’s disease whose medication wears off between doses, and concluded that the drug’s benefits outweigh its risks and issued a positive opinion recommending approval.
At this point, the findings and recommendations are sent to the European Commission for final approval, which can take up to 67 days. If approved, Hopledo could begin reaching patients in Europe later this year through a phased rollout. The CHMP’s recommendation was based on results from the Phase 3 RISE-PD clinical trial, which compared Hopledo with immediate-release levodopa/carbidopa in patients with moderate-to-severe motor fluctuations. Investigators reported that patients taking Hopledo experienced significantly more “Good ON” time and required fewer daily doses while maintaining a safety profile comparable to that of standard therapy.
Many people with Parkinson’s disease struggle with something called “motor fluctuations.” As the disease gets worse, patients need to take their medication (levodopa) more and more often, but even so, they still have unpredictable stretches where symptoms like tremor, slow movement, and stiffness come back before it’s time for the next dose. Company officials say more than a million people in the European Union have Parkinson’s, and more than 80 percent of them will eventually deal with these ups and downs in symptom control.
Zambon bought the rights to sell a drug called IPX203 in Europe, the UK, and Switzerland from Amneal Pharmaceuticals back in 2024. If EU regulators give final sign-off, the companies expect the drug, which will be sold under the name Hopledo, will start rolling out across European countries beginning in October 2026. Exact availability will depend on each country’s own decisions about pricing and insurance coverage.
For patients and doctors, this is another step toward giving people more steady symptom control and cutting down on how often they have to think about timing their pills. Hopledo won’t slow down Parkinson’s itself, but it may help many patients feel more functional for more of the day, with fewer episodes of their medication wearing off too soon.
Read the press release from Amneal Pharmaceuticals here
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