FDA approves Onapgo for motor fluctuations in adults with Parkinson’s disease
Key takeaways:
- Onapgo is the first subcutaneous apomorphine infusion device approved to treat motor fluctuations in Parkinson’s disease.
- Onapgo reduced “off” time, as well as increased “good on” time compared with placebo.
The FDA has approved Onapgo, the first subcutaneous apomorphine device to treat motor fluctuations in adults with Parkinson’s disease, according to the manufacturer.
In a press release, Supernus Pharmaceuticals Inc. said the approval of Onapgo (apomorphine hydrochloride) was based on results from a 12-week, phase 3, multicenter, parallel-group, double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of the device in 107 individuals with the neurodegenerative condition.
Treatment with Onapgo led to positive results with respect to the primary efficacy endpoint of mean change from baseline to end of treatment, with a mean reduction in total daily “off” time of 2.6 hours compared with 0.9 hours for the placebo group.
For the secondary endpoint of mean change in daily “good on” time without troublesome dyskinesia, the mean change from baseline to end of treatment was an increase of 2.8 hours for the Onapgo group vs. 1.1 hours for those given placebo.
According to the release, “PD is the second-most common neurodegenerative disorder of aging.”
“My grandfather had Parkinson’s disease and, as a child and a teenager, I saw how difficult it was for him and my family,” Supernus Chief Medical Officer Jonathan Rubin, MD, MBA, told Healio. “I’m proud that Onapgo is a much-needed new treatment option and supported by the Circle of Care program, providing patients and care partners with access to experts who provide comprehensive and continuous support from the moment Onapgo is prescribed.”
Treatment with Onapgo led to positive results with respect to the primary efficacy endpoint of mean change from baseline to end of treatment, with a mean reduction in total daily “off” time of 2.6 hours compared with 0.9 hours for the placebo group.
For the secondary endpoint of mean change in daily “good on” time without troublesome dyskinesia, the mean change from baseline to end of treatment was an increase of 2.8 hours for the Onapgo group vs. 1.1 hours for those given placebo.
Additionally, according to the release, individuals treated with Onapgo more frequently reported a boost in their overall health compared with participants in the placebo group.
The most common adverse events, per the release, were infusion-site nodule, nausea, somnolence, dyskinesia, headache and insomnia.
Supernus said it plans to officially launch Onapgo during the second quarter of this year.
Perspective
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The approval of Onapgo, a new wearable, subcutaneous apomorphine infusion device, offers yet another useful advance in helping adults with advanced PD to manage their symptoms.
As PD progresses, the power of first-line medications to keep motor dysfunction in check between doses begins to wane, increasing patients’ “off” times at unpredictable rates. The exciting thing about this new therapy and a similar continuous infusion therapy (Vyalev; (foscarbidopa/foslevodopa, AbbVie) approved a few months earlier is that patients get a constant dose of medication that keeps their symptoms more predictable throughout the day.
These medications can cause nausea and other side effects, which neurologists should discuss with their patients. These continuous infusion systems are helpful additions to, rather than replacements for, current PD medications.
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