Parkinson’s Disease Gets New Treatment Approved

The FDA approved the dopamine agonist tavapadon (Juvmo) to treat adults with Parkinson’s disease, drugmaker AbbVie announced Monday.

Tavapadon is an oral selective D1/D5 dopamine agonist that was studied as monotherapy for early Parkinson’s in the TEMPO-1 and TEMPO-2 trials, and as adjunctive therapy with oral levodopa in advanced Parkinson’s patients who had motor fluctuations in the TEMPO-3 trial.

Dopamine agonists are used to help manage symptoms and reduce reliance on oral levodopa escalation. Tavapadon is the first D1/D5 receptor agonist approved for Parkinson’s; other available dopamine agonists primarily target D2/D3 receptors.

“Parkinson’s disease treatment has long required healthcare providers to balance the need for dependable motor symptom control with considerations around treatment tolerability,” said principal TEMPO trial investigator Hubert Fernandez, MD, of the Cleveland Clinic Lerner College of Medicine, in a news release.

“Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides healthcare providers with greater flexibility to tailor treatment to individual patient needs,” he added.

In the TEMPO-1 (fixed dose) and TEMPO-2 (flexible dose) studies, participants receiving tavapadon as monotherapy had a significant reduction in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part II and III combined scores at week 26 compared with placebo. MDS-UPDRS parts II and III scores reflect activities of daily living and motor performance.

In TEMPO-3, tavapadon adjunctive to levodopa significantly increased daily “on” time without troublesome dyskinesia at 27 weeks compared with placebo. Sustained efficacy to 85 weeks was seen for patients who continued in the open-label TEMPO-4 extension, AbbVie said.

Most adverse events in the trials were non-serious and mild or moderate in severity. The most common adverse events for tavapadon without oral levodopa included nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety. When used with concomitant oral levodopa, the most common adverse events were nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension.

The drug may cause serious side effects. Prescribing information warns that tavapadon can cause hypotension or orthostatic hypotension, or lead to new or worsening dyskinesia. It may cause problems with impulse control or compulsive behaviors; if so, dose reductions or stopping treatment should be considered.

Tavapadon also may lead to psychotic-like behavior and hallucinations, which may be increased when it is co-administered with strong CYP3A inhibitors during the maintenance phase.

The drug will be available as 5-mg, 10-mg, and 15-mg tablets, as well as 0.25-mg and 1-mg tablets contained in a titration pack, AbbVie said. The company plans to make tavapadon available to U.S. patients in October.