The Food and Drug Administration (FDA) has approved Juvmo™ (tavapadon) for the treatment of Parkinson disease (PD) in adults.

The approval was based on data from the TEMPO clinical trial program, which evaluated tavapadon, a selective dopamine D1/D5 receptor partial agonist, in patients with early PD not on concomitant levodopa (TEMPO-1 [ClinicalTrials.gov Identifier: NCT04201093] and TEMPO-2 [ClinicalTrials.gov Identifier: NCT04223193]) and as an adjunctive therapy to levodopa in PD patients experiencing motor fluctuations (TEMPO-3 [ClinicalTrials.gov Identifier: NCT04542499]).

In TEMPO-1, study participants (N=529; mean age 63.7 years) were randomly assigned to receive tavapadon 5mg, tavapadon 15mg or placebo once daily. The primary endpoint was the change from baseline in activities of daily living scores. This was measured by the Movement Disorder Society-sponsored revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II at week 26, with a negative change representing an improvement.

Findings showed treatment with tavapadon led to a statistically significant improvement in activities of daily living compared with placebo (change from baseline in MDS-UPDRS Parts II score: placebo: +0.9; tavapadon 5mg: -1.6; tavapadon 15mg: -1.7; P <.0001 each dose vs placebo).

In TEMPO-2, study participants (N=304; mean age, 62.9 years) were randomly assigned to receive flexible doses of tavapadon (5-15mg once daily) or placebo. Similar to TEMPO-1, results demonstrated a statistically significant difference in mean change from baseline in MDS-UPDRS Part II score at week 26 for patients treated with tavapadon compared with those receiving placebo (-1.5 vs 0.0; P =.0007).

TEMPO-3 included 507 levodopa-treated patients (mean age, 64.9 years) who were randomly assigned to receive tavapadon 5 to 15mg orally (n=252) or placebo (n=255) once daily as adjunctive therapy. The primary endpoint was the change from baseline in the total daily ON time without troublesome dyskinesia at week 26 based on the self-completed home diary for motor function status (Hauser diary).

In this trial, the addition of tavapadon to levodopa significantly increased total ON time without troublesome dyskinesia compared with placebo plus levodopa (1.7 hours vs 0.6 hours, respectively; P <.0001). Moreover, tavapadon met the key secondary endpoint demonstrating a statistically significant reduction in OFF time (-1.9 hours vs -0.9 hours with placebo; P =.0006). 

“Parkinson disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability,” said Hubert Fernandez, MD, professor of neurology at the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator. “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.”

The most common adverse reactions reported with tavapadon were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety. The prescribing information also lists warnings and precautions regarding hypotension/orthostatic hypotension, impulse control and compulsive behaviors, hallucinations and psychotic-like behavior, and dyskinesia. 

Juvmo is supplied as a tablet in 0.25mg, 1mg, 5mg, 10mg, and 15mg strengths. Patients initiating treatment should follow the recommended titration schedule to reach the 5mg once daily maintenance dosage. The maintenance dose may be increased in increments of 5mg approximately every 15 days to the maximum recommended dosage of 15mg once daily based on tolerability and clinical response. Dosage modification may be required to avoid significant drug interactions.

Juvmo is expected to be commercially available in October 2026.