AbbVie recently announced that the US Food and Drug Administration (FDA) has approved JUVMO (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for the treatment of adults with Parkinson's Disease (PD).

Roopal Thakkar, MD, Executive Vice President, Research and Development (R&D), Chief Scientific Officer, AbbVie, said, "The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson's Disease in decades. People living with Parkinson's and the clinicians who care for them have long faced difficult tradeoffs between motor control, treatment burden and tolerability. Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists."

For people living with PD, maintaining consistent control of motor symptoms becomes increasingly challenging as the disease progresses. Oral levodopa remains the foundation of treatment and is often effective at controlling symptoms, but many patients require higher and more frequent doses over time. These adjustments can help restore symptom control yet may also contribute to treatment-related complications such as dyskinesia.

About 70 percent of people living with PD have their oral levodopa dose increased within the first year of therapy.

These challenges highlight the need for new treatment approaches that can help address the evolving needs of people living with PD.

After 85 weeks on JUVMO, 93 percent of clinical trial participants had not increased their oral levodopa dose and 94 percent of participants with early PD had not started oral levodopa.

Dopamine agonists have long been used to help manage symptoms and reduce reliance on oral levodopa escalation. However, currently available dopamine agonists primarily target D2/D3 receptors and their use may be limited by tolerability concerns. JUVMO introduces a different approach, selectively targeting D1/D5 receptors to provide health care providers and patients with a new option for managing motor symptoms across the PD continuum.

Hubert Fernandez, MD, Professor of Neurology, Cleveland Clinic Lerner College of Medicine, and global principal TEMPO trial investigator, said, "Parkinson's Disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability. Now, we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs."

AbbVie expects to make JUVMO available to patients in the US in October 2026.

Phase 3 data from the TEMPO clinical trial program demonstrated the efficacy and safety of JUVMO in people with early PD who were not taking oral levodopa (TEMPO-1 and 2) and as an adjunct to oral levodopa in people with PD experiencing motor fluctuations (TEMPO-3).

Brian Fiske, PhD, Chief Scientist, The Michael J Fox Foundation for Parkinson's Research, said, "For people with Parkinson's and their families, progress means having treatment options that deliver meaningful benefit in everyday life. Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson's community."

In TEMPO-1 at week 26, JUVMO significantly improved activities of daily living scores versus placebo, as measured by MDS-UPDRS part 2, which includes everyday tasks like dressing, eating and personal hygiene (placebo: +0.9; 5 mg: -1.6; 15 mg: -1.7; p <0.0001 each dose versus placebo). Compared to baseline, JUVMO improved activities of daily living scores by 22-23 percent whereas the placebo group worsened by 12 percent.

Additionally, JUVMO significantly improved activities of daily living and motor skills, as measured by MDS-UPDRS part 2 + 3 combined scores, versus placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2; p <0.0001 each dose versus placebo) at week 26.

JUVMO also significantly improved MDS-UPDRS part 2 scores versus placebo in TEMPO-2 at week 26 (placebo: 0.0; 5-15 mg: -1.5; p =0.0007). It also significantly improved MDS-UPDRS part 2 + 3 combined scores versus placebo in TEMPO-2 at week 26 (placebo: -1.2; 5-15mg: -10.3; p <0.0001).

In TEMPO-3 at week 26, JUVMO 5-15 mg + oral levodopa significantly increased total daily "on" time without troublesome dyskinesia versus placebo + oral levodopa (1.7 hours versus 0.6 hours, p <0.0001). Total daily "off" time decreased by 1.9 hours with JUVMO + oral levodopa, compared to a decrease of 0.9 hours with placebo + oral levodopa (p =0.0006).

Sustained efficacy was observed out to 85 weeks for those who continued in the open-label extension period (TEMPO-4). Of those on JUVMO + oral levodopa for 85 weeks, 93 percent did not increase their oral levodopa dose (96/103). Of those on JUVMO without levodopa, 94 percent did not initiate levodopa (257/273).

The majority of Treatment-Emergent Adverse Events (TEAEs) were non-serious and mild or moderate in severity.

The most common TEAEs for JUVMO without oral levodopa, reported in ≥5 percent of patients, were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety. For JUVMO + oral levodopa, the most common TEAEs, reported in ≥5 percent of patients, were nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension.