Global biopharmaceutical company AbbVie (NYSE:ABBV) announced on Friday that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease.

The NDA submission is based on results from the TEMPO clinical development programme that assessed the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population. It includes 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 also includes an interim data cut from TEMPO-4, an open-label extension (OLE) trial to evaluate the long-term clinical benefit of tavapadon.

Roopal Thakkar, MD., executive vice president, research and development, chief scientific officer at AbbVie, said: "For many people living with Parkinson's disease, today's oral standard of care isn't effective enough to manage symptoms. We recognise 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."