On September 25, the US Food and Drug Administration (FDA) granted approval to tavapadon (Juvmo, AbbVie) as a treatment for Parkinson’s disease in adults. This daily oral medication can be administered either independently or alongside levodopa, offering clinicians a novel dopaminergic option for various stages of Parkinson’s disease management.
Unlike existing dopamine agonists that primarily engage D2/D3 receptors, tavapadon specifically activates D1/D5 receptors.
Tavapadon Mechanism and Treatment
As an oral dopamine agonist, tavapadon uniquely targets D1 and D5 dopamine receptors, setting it apart from traditional agonists that focus on D2/D3 receptors. Treatment begins with a titration pack containing 0.25-mg and 1-mg tablets for gradual dose adjustment.
Once the maintenance phase is reached, tavapadon is available in 5-mg, 10-mg, and 15-mg tablets. While levodopa remains central to symptom management in Parkinson’s disease, treatment needs shift as the condition progresses. Patients may require more frequent dosing or additional therapies as symptom control becomes inconsistent and periods of reduced mobility, or “off” time, increase.
Evidence in Early Parkinson’s Disease
Two phase 3 trials, TEMPO-1 and TEMPO-2, investigated tavapadon as a standalone therapy for early-stage Parkinson’s disease. Both trials measured changes in the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III, focusing on motor aspects of daily living and motor examination findings.
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In TEMPO-1, 529 adults diagnosed with Parkinson’s disease within the past 3 years were randomly assigned to receive either tavapadon 5 mg (n=177), tavapadon 15 mg (n=177), or a placebo (n=175) daily. By week 26, combined MDS-UPDRS Parts II and III scores improved significantly by 9.7 points with the 5-mg dose and 10.2 points with the 15-mg dose, compared to a 1.8-point decline in the placebo group.
The TEMPO-3 trial examined tavapadon as an add-on therapy for patients experiencing motor fluctuations despite levodopa treatment. It enrolled 507 adults with Parkinson’s disease and motor fluctuations, who were randomized to receive either flexible-dose tavapadon (5 to 15 mg) daily or a placebo for 27 weeks, in addition to levodopa.
By week 26, patients on tavapadon gained 1.7 hours of daily “on” time without troublesome dyskinesia, compared to 0.6 hours with placebo. AbbVie reported that 93% of patients on tavapadon with levodopa did not increase their levodopa dose, while 94% on tavapadon alone did not start levodopa.
Safety data from the TEMPO trials indicated that most side effects were mild to moderate and non-serious. Common side effects in at least 5% of patients on tavapadon monotherapy included nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety.
Long-Term Efficacy and Availability
AbbVie reported sustained benefits through 85 weeks for patients continuing treatment. AbbVie expects Juvmo to become available in the United States.