AbbVie Submits NDA for Parkinson’s Disease Drug, Tavapadon

AbbVie has submitted a New Drug Application (NDA) to the FDA for tavapadon, an investigational, oral, once-daily treatment for Parkinson’s disease to be used with or without levodopa, according to a news release published today.

"For many people living with Parkinson's disease, today's oral standard of care isn't effective enough to manage symptoms," Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie, said in the news release.

Parkinson’s is a progressive neurological disorder caused by the death of dopamine-producing neurons in the brain, specifically in the basal ganglia, the area of the brain that controls movement.

Motor symptoms such as shaking, stiffness and difficulty with balance appear when approximately 60 to 80% of dopamine-producing cells are lost. This may eventually lead to difficulty walking and talking or behavioral changes such as depression, fatigue or memory difficulties.

More than 11 million people worldwide have Parkinson's, including more than 1 million Americans. While the exact cause is unknown and there is no cure, there are treatments that can lessen symptoms, such as dopamine agonists, enzyme inhibitors and anticholinergic drugs that reduce tremors.

Most FDA-approved Parkinson’s medications are taken multiple times a day. “Off” periods, or periods when symptoms return or worsen between medication doses, are reported by 90% of patients. Approximately 65% of patients also spend two or more hours a day in “off” periods.

Tavapadon is a once-daily oral, novel selective D1/D5 receptor partial agonist that stimulates dopamine receptors partway, which theoretically may cause fewer side effects than other Parkinson’s medications that can cause difficulty swallowing, sleep problems and anxiety.

Today’s NDA submission was based on the results from the TEMPO clinical program, which demonstrated symptom improvement in Parkinson’s patients treated with tavapadon.

TEMPO-1 and TEMPO-2 studied the effects of tavapadon in early Parkinson’s patients. Results showed that patients given tavapadon experienced a statistically significant improvement of 9 points on average when compared to placebo, determined using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, parts 2 and 3.

Specifically, in TEMPO-1, researchers enrolled a total of 529 patients between the ages of 40 and 80, with a confirmed Parkinson’s diagnosis and less than three years of disease duration. Patients were randomly selected to receive 5 mg or 15 mg of tavapadon or a placebo.

In TEMPO-2, researchers enrolled 304 patients between the ages of 40 and 80 who were randomized to receive either 5-15 mg of tavapadon or a placebo, orally and once daily.

TEMPO-3 tested the effectiveness of the combination of tavapadon and levodopa in patients with mild symptoms or a placebo. Levodopa is the most common medication used to treat Parkinson’s.

Patients treated with a combination of tavapadon and levodopa reported an increase of 1.1 hours of daily “on” time when compared with placebo.

The most common adverse reactions reported in at least 10% of patients included nausea, headache and dizziness for patients who received only tavapadon and nausea and dyskinesia for patients who received levodopa and tavapadon.

TEMPO-4 is an ongoing study examining the long-term safety and efficacy of tavapadon through 58 weeks of treatment. It is expected to be completed in January 2026.