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FDA Approves Juvmo, a Different Kind of Parkinson’s Pill 40 Years in the Making

The FDA-approved Juvmo pill is due in US pharmacies this month. Here is how it works, what trials showed, and what is still unknown.

Juvmo Parkinson's drug pill and brain scan glowing in red, white and blue light
AbbVie's Juvmo (tavapadon) is a once-daily pill for adults with Parkinson's disease.

For people living with Parkinson’s, a pill that works in a different way has been a long time coming. The new Juvmo Parkinson’s drug is supposed to reach US pharmacies this month, and the story behind it is a 40-year science project that finally paid off.

The FDA approved AbbVie’s once-daily pill, known generically as tavapadon, for adults with Parkinson’s disease. Reuters, citing the FDA website, reported the approval on Sept. 25. AbbVie’s own announcement followed on Sept. 28. Here is what the drug does, what the trials showed, and what is still unknown.

Why the Juvmo Parkinson’s drug is different

For nearly 60 years, levodopa has been the gold standard for Parkinson’s. It works by supplying the brain with dopamine. The problem is that it fades as the brain’s dopamine-producing cells keep dying.

Juvmo takes another route. AbbVie says it is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s. In plain English, it switches on a specific set of receptors in the brain, instead of just adding more dopamine.

Patients take the pill once a day, with or without levodopa. That sounds small, but it is not. According to the University of Virginia’s release, earlier drugs of this type could only be injected.

The UVA story behind the new Parkinson’s pill

The science traces back to Charlottesville. UVA says pharmacologist Richard Mailman had his breakthrough in 1984. At the time, existing drugs targeted only “D2-like” receptors. However, his experiments suggested “D1-like” receptors were responsible for most of levodopa’s benefit.

“We figured out the specific mechanism that made levodopa effective, and developed the first drug that could turn on that mechanism,” Mailman said in UVA’s release. UVA also credits neurologist Xuemei Huang with a vital role in the first successful clinical trial of a drug in this class.

Mailman’s own explanation of why he stuck with it is simple. “It was involuntary. As a scientist, I couldn’t let it go,” he told WSET.

What the trials showed

The approval rests on a Phase 3 program called TEMPO. According to Medscape, TEMPO-1 enrolled 529 patients and TEMPO-2 enrolled 304. Both tested the drug on its own in early Parkinson’s. Patients on the drug had a significant reduction in combined symptom scores at 26 weeks compared with placebo.

TEMPO-3 tested Juvmo as an add-on to levodopa in patients with motor fluctuations. Compared with placebo, it increased daily “on” time, when symptoms are controlled, and cut “off” time.

UVA Health also points to a longer-term number. About 70% of patients on levodopa need a dose increase within the first year. In the Juvmo trials, though, 93% had not increased their levodopa dose after 85 weeks, and 94% of those with early disease had not needed to start levodopa, Cville Right Now reported.

The side effects of this Parkinson’s treatment

Here is the trade-off. In the trial data reported by Drug Topics, adverse events led 18.1% of patients in the tavapadon groups to stop the drug, versus 4.0% on placebo. The most common side effects with Juvmo plus levodopa include nausea, dyskinesia, dizziness, headache, hallucinations and low blood pressure when standing.

Doctors also watched for impulse control problems. In TEMPO-3, 6 patients (2.4%) on tavapadon had events suggestive of them, versus 3 (1.2%) on placebo. Anyone with Parkinson’s should talk to a neurologist about whether this fits them. Nothing here is a reason to change treatment on your own.

Here’s the thing: more than 11 million people worldwide live with Parkinson’s, per Reuters. For them and their families, a new, well-tolerated option that may delay or reduce levodopa increases is a big deal. Meanwhile, new research on exercise and slower Parkinson’s decline suggests drugs are not the only lever patients can pull.

What we don’t know yet

Price is the big blank. AbbVie did not respond to Reuters about launch details and pricing, and no list price has been published. AbbVie says it expects the drug to be available in the US in October, but nothing confirms it is on pharmacy shelves yet.

Coverage is the other question. Citi analysts told Reuters uptake would likely be gradual as Medicare coverage talks progress. That is an analyst view, not an announced policy. For context on the wider policy fight, see our look at what is in Trump’s new health plan.

The business stakes are large. AbbVie got tavapadon through its $8.7 billion purchase of Cerevel Therapeutics in 2023, and Citi says the company is targeting more than $5 billion in combined Parkinson’s sales. The company is also moving fast elsewhere, as when the FDA fast-tracked AbbVie’s Temab-A in two cancers.

The science took four decades. What happens next depends on price, coverage and how fast pharmacies stock it, and those answers will decide who actually gets the pill.

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