ONAPGOTM: A Newly-Approved Medication for OFF Periods in Parkinson’s
Breaking News! The first subcutaneous (under the skin) apomorphine infusion, now called ONAPGOTM, was approved by the Food and Drug Administration (FDA) on February 4, 2025. Apomorphine is a dopamine agonist whose effects have a rapid onset. It has been available in the US as a subcutaneous injection, known as Apokyn®, which is used ‘as needed’ if someone is experiencing OFF time, or periods during the day when PD symptoms are not well controlled. Now this medication is also available via a subcutaneous infusion device, providing continuous treatment of apomorphine during the waking day for more consistent control of PD symptoms and decrease in OFF time. The apomorphine subcutaneous infusion has been a treatment option for people with PD in Europe for many years.
The therapy’s approval was based on data from the TOLEDO study (NCT02006121), a randomized, placebo-controlled, double-blind study of 107 people with PD whose symptoms were not controlled optimally with oral medication. Those who were treated with the subcutaneous apomorphine pump had close to two hours less of OFF time in a day, as compared to those treated with the placebo.
ONAPGOTM was brought to market by the pharmaceutical company Supernus, which reports that the therapy will be available for use in the U.S. within the next few months. Insurance coverage, including Medicare coverage, will evolve over the next few months as well.
APDA is thrilled that there is an additional treatment option for people with PD, as each new offering provides doctors with more options to personalize treatment plans for each individual patient. We will continue to provide updates as new therapies become available.