#AANAM – Opicapone Can Prolong ‘On-Time’ Levopoda Provides, Data from Phase 3 Trials Show

#AANAM – Opicapone Can Prolong ‘On-Time’ Levopoda Provides, Data from Phase 3 Trials Show
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Once-daily opicapone can prolong the time during which treatment with levopoda, a standard therapy, effectively prevents motor symptom fluctuations in people with Parkinson’s disease, results from two international Phase 3 studies show.

The findings, “Once-Daily Opicapone Increases ON-Time in Patients with Parkinson’s Disease: Results from Two Phase 3 Studies,” were presented during the 2019 Annual Meeting of the American Academy of Neurology (AAN), now underway in Philadelphia.

Opicapone, developed by Bial and Neurocrine Biosciences, is designed as a once-a-day add-on therapy to levodopa for adults with Parkinson’s and end-of-dose motor fluctuations.

It works as an inhibitor (blocker) of the enzyme catechol-o-methyltransferase, or COMT, which breaks down levodopa. This can  prolong levodopa effects, known as “on-time” or “on-periods,” as it lessens the time when the medication wears off before the next dose — so-called “off periods.”

Opicapone is marketed in Europe under the brand name Ongentys, and approved for patients with fluctuations that cannot be treated with lepodova or combinations of similar therapies, and whose motor symptoms re-emerge before the next dose is due.

Neurocrine, which holds a North American license for it, has announced plans to submit an approval request for this potential treatment to the U.S. Food and Drug Administration (FDA) this year.

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Potential benefits of opicapone were assessed in two Phase 3 trials, BIPARK-1 (NCT01568073) and BIPARK-2 (NCT01227655). The trials enrolled more than 900 Parkinson’s patients who could not effectively control their motor symptoms with standard therapies. In BIPARK-1, they were randomly assigned to receive 5, 25, or 50 mg daily doses of opicapone, plus either levodopa or Comtan (entacapone, sold by Novartis), or a placebo. In BIPARK-2, opicapone was given as an add-on to either levodopa or placebo.

After 14 to 15 weeks of treatment, patients had the opportunity to continue opicapone add-on therapy for more than one year in an open-label extension study.

Data from the BIPARK-1 trial showed that people treated with 50 mg opicapone experienced about twice longer on-time periods without dyskinesia (involuntary movements) compared to those given a placebo. (Ongentys is available in Europe as 25 mg and 50 mg capsules; the higher dose is the recommended bedtime dose.)

Similar results were reported in the BIPARK-2 study, in which patients taking 50 mg of opicapone had 1.7 hours of absolute on-time without dyskinesia compared to 0.9 hours in the placebo group.

Longer on-time periods were also observed in long-term extension studies in all opicapone-treated patients, with increases of 2 and 1.8 hours in the BIPARK-1 and BIPARK-2 trials, respectively, the presentation data also show.

In terms of safety, pooled data from the two studies found that more patients in the opicapone-treated group experienced common dyskinesia that was linked to the treatment, compared to those in the placebo arm (17.4% vs 6.2%, respectively). But reported incidences of severe or serious dyskinesia were low, and few from either group withdrew from the studies.

“Once-daily opicapone increased ON-time without troublesome dyskinesia in Parkinson’s disease patients with motor fluctuations,” the researchers wrote.

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