(RTTNews) - AbbVie (ABBV) has submitted a New Drug Application to the FDA for tavapadon, a selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease. The submission is based on results from the TEMPO clinical development program. This included two Phase 3 trials - TEMPO-1 and TEMPO-2 - in early Parkinson's disease, and one Phase 3 trial - TEMPO-3 with tavapadon as adjunctive to levodopa in patients experiencing motor fluctuations. The submission is also based on an interim data cut from TEMPO-4, an open-label extension trial.
Roopal Thakkar, chief scientific officer, AbbVie, said: "We recognize the physical and mental impact that Parkinson's disease can cause and are committed to providing next-generation treatment options that will help individuals regain motor control and independence at all stages of this challenging disease."
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