AbbVie Files FDA Submission for Tavapadon in Parkinson’s Disease

AbbVie Files FDA Submission for Tavapadon in Parkinson’s Disease

By, Admin 27 September 2025

AbbVie (NYSE: ABBV) has submitted a New Drug Application (NDA) to the US FDA for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist studied as a once-daily oral therapy for Parkinson’s disease.

Backed by Phase 3 TEMPO Program

The filing is supported by data from the TEMPO clinical program, which included:

  • TEMPO-1 and TEMPO-2: Trials in early Parkinson’s disease showing significant improvement in MDS-UPDRS Part II and III combined scores at week 26.
  • TEMPO-3: An adjunctive trial with levodopa showing increased “on” time without troublesome dyskinesia.
  • TEMPO-4: An ongoing open-label extension assessing long-term benefit over 58 weeks.

Across all three pivotal studies, tavapadon demonstrated symptom improvement and functional gains for patients at different stages of Parkinson’s.

AbbVie’s Perspective

“For many living with Parkinson’s, current oral treatments aren’t enough. We are committed to next-generation options that restore motor control and independence.”

  • Dr. Roopal Thakkar, Chief Scientific Officer at AbbVie.

Safety and Tolerability

  • Most side effects were mild or moderate.
  • Serious adverse events and deaths were low and comparable to placebo.
  • The most common reactions were nausea, headache, dizziness (without levodopa) and nausea, dyskinesia (with levodopa).

Parkinson’s Disease Context

  • 11 million people worldwide live with Parkinson’s disease.
  • Symptoms appear when 60–80% of dopamine-producing brain cells are lost.
  • Patients cycle between “on” states (controlled symptoms) and “off” states (tremor, stiffness, limited movement).
  • Advanced disease often brings dyskinesia, which disrupts daily living.
  • While there is no cure, therapies like tavapadon may expand symptom control options.

AbbVie in Neuroscience

With over 30 years in neuroscience, AbbVie has built a portfolio across migraine, movement disorders, and psychiatric conditions. Tavapadon reinforces its strategy to deliver innovative therapies in neurological care.

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