AbbVie has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for tavapadon.
Tavapadon is a novel 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 programme that evaluated the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population.
This includes two Phase III trials (TEMPO-1 and TEMPO-2) in early Parkinson's disease and one Phase III trial (TEMPO-3) with tavapadon as an adjunctive to levodopa in patients experiencing motor fluctuations.
TEMPO-1 and TEMPO-2 demonstrated that patients experienced a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.
TEMPO-3 demonstrated that patients experienced more "on" time, referring to the period when symptoms were well controlled without dyskinesia or involuntary movements.
The submission is also based on an interim data cut from TEMPO-4, an open-label extension (OLE) trial to assess the long-term clinical benefit of tavapadon.
"For many people living with Parkinson's disease, today's oral standard of care isn't effective enough to manage symptoms," said Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie.
"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."
The submission is supported by results from three placebo-controlled studies.
TEMPO-1 and -2 enrolled patients with early Parkinson's disease (with or without an MAO-B inhibitor) and TEMPO-3 enrolled patients who are on fixed-dose levodopa and had motor fluctuations.
An open-label extension study (TEMPO-4) is currently ongoing to assess the long-term safety and efficacy of tavapadon through 58 weeks of treatment.
TEMPO-4 enrolled patients who completed participation in TEMPO-1 through 3, as well as patients on stable doses of levodopa who had not been in prior TEMPO trials.