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FDA approval · AbbVie · Neurology

Juvmotavapadon

First selective D1/D5 dopamine agonist approved for Parkinson's disease.

CompareAbbVie press release
FDA approval · New moleculeFirst selective D1/D5 agonist50-second read

Juvmotavapadon

AbbVie · Selective dopamine D1/D5 receptor agonist · Neurology

Bottom line for your patients

Adults with Parkinson's disease have a once-daily oral dopamine agonist that can be used with or without levodopa. In Phase 3 trials it improved activities of daily living scores in early disease and, added to levodopa, increased "on" time without troublesome dyskinesia.

Drug brief
Drug IQ
Who it is for
Adults with Parkinson's disease.
What changes
AbbVie states that currently available dopamine agonists primarily target D2/D3 receptors and that their use may be limited by tolerability concerns, while Juvmo selectively targets D1/D5 receptors. The Phase 3 TEMPO trials compared Juvmo with placebo, not with another dopamine agonist.
The evidence
In TEMPO-1 at week 26, MDS-UPDRS Part II scores changed by -1.6 (5 mg) and -1.7 (15 mg) versus +0.9 with placebo (p <0.0001 for each dose). In TEMPO-3 at week 26, Juvmo plus oral levodopa increased daily "on" time without troublesome dyskinesia by 1.7 hours versus 0.6 hours with placebo plus oral levodopa (p <0.0001).Placebo-controlled randomized trialTEMPO-1, TEMPO-2 and TEMPO-3 · Phase 3Randomized against placebo: shows that it works, not how it compares with existing treatments.
Watch for
Safety information lists low blood pressure including orthostatic hypotension, unusual urges, hallucinations and dyskinesia. The most common adverse events (at least 5% of patients) were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety without levodopa, and nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension with levodopa.
How it is given
OralTablet taken once daily, with or without levodopa.
What the approval tells you
New molecule. An active ingredient the FDA had not approved before.

Clinical summary

A once-daily oral tablet for adults with Parkinson's disease, with or without levodopa; unlike existing agonists, which act mainly on D2/D3 receptors, it selectively activates D1/D5. In TEMPO-3, as adjunct to levodopa in patients with motor fluctuations, daily 'on' time without troublesome dyskinesia rose by 1.7 hours versus 0.6 hours with placebo. Warnings include orthostatic hypotension, hallucinations, dyskinesia and impulse-control urges.

From the source 10

AbbVie press release

The AbbVie press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. AbbVie (NYSE: ABBV) today announced that the U.S. 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, a progressive neurological disorder that affects millions of people worldwide.

    Backs · First and only selective D1/D5 receptor agonist; approved for adults with Parkinson's disease

  2. Taken once daily with or without levodopa therapy, JUVMO offers patients a differentiated approach to motor symptom control across the Parkinson's disease continuum

    Backs · Once daily, with or without levodopa

  3. JUVMO tablet for oral use is 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.

    Backs · Tablet strengths 5 mg, 10 mg, 15 mg; 0.25 mg and 1 mg in Titration Pack

View all 10 lines

  1. However, currently available dopamine agonists primarily target D2/D3 receptors and their use may be limited by tolerability concerns.

    Backs · Existing dopamine agonists primarily target D2/D3 receptors; use may be limited by tolerability

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

    Backs · Phase 3 TEMPO program; TEMPO-1 and 2 in early disease without levodopa, TEMPO-3 as adjunct to levodopa

  3. In TEMPO-1 at week 26, JUVMO significantly improved activities of daily living scores versus placebo, as measured by MDS-UPDRS Part II, 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).

    Backs · TEMPO-1 week 26 MDS-UPDRS Part II: placebo +0.9; 5 mg -1.6; 15 mg -1.7; p <0.0001

  4. 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)

    Backs · TEMPO-3 week 26: 1.7 hours versus 0.6 hours of "on" time without troublesome dyskinesia; p <0.0001

  5. The most common TEAEs for JUVMO without oral levodopa, reported in ≥5% of patients, were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety.

    Backs · Most common adverse events without levodopa, at least 5%

  6. For JUVMO + oral levodopa, the most common TEAEs, reported in ≥5% of patients, were nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension.

    Backs · Most common adverse events with levodopa, at least 5%

  7. Sustained efficacy was observed out to 85 weeks for those who continued in the open-label extension period (TEMPO-4).

    Backs · TEMPO-4 is the open-label extension

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