In the U.S., over one million people live with Parkinson’s. While there are symptom-treating medications that help tame motor symptoms like tremors, rigidity, slow movements, and posture problems, many of the medications need to be taken multiple times a day and come with side effects. These include dyskinesia, which causes uncontrolled erratic movements, and impulse control disorder, which causes problematic behaviors like gambling, leading some to discontinue their medications within the first year.
The Food and Drug Administration approved AbbVie’s new once-daily Parkinson’s pill, Juvmo (called tavapadon during clinical trials), on Sept. 25 as a standalone in early Parkinson’s to provide an option with fewer side effects or as an add-on to existing medications in later stages to prolong their effects.
“Parkinson’s disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability,” said Dr. Hubert Fernandez, professor and neurologist at the Cleveland Clinic, who was the global investigator on two of the drug’s Phase 3 trials, in a press release. He said the approval of Juvmo “ provides health care providers with greater flexibility to tailor treatment to individual patient needs.”
AbbVie expects the drug will be available in October 2026.
How does tavapadon work?
In Parkinson’s, the neurons that produce the neurotransmitter dopamine die off, leading to the disease’s motor symptoms. Existing medications called dopamine agonists mimic the effects of dopamine by activating the circuitry that dopamine targets: the D2 and D3 receptor proteins. But activating this circuitry is linked to many medication side effects. Juvmo instead works by activating other dopamine pathways by targeting the D1 and D5 receptors.
AbbVie tested Juvmo in three 26-week Phase 3 placebo-controlled randomized trials with over 1,300 participants. The first two trials, testing it as a standalone medication, found that it led to noticeable and meaningful improvements in motor symptoms with mild to moderate side effects, like nausea and headache.
The third trial tested it as an add-on and found that it helped prolong “on time,” the period where a Parkinson’s medication works, and also reduce “off time,” when the effects wear away. Still, the trials aren’t long enough to determine whether the treatment reduces the risk of impulse control problems.
“It’s not a huge game-changer, but definitely a nice additional tool to have,” Dr. Bryan Ho, neurologist and director of the Movement Disorders Program at Tufts Medical Center, previously told Being Patient. He sees it especially useful for older patients who are more vulnerable to the side effects of other therapies.