AbbVie submits Parkinson’s disease therapy to FDA

AbbVie has submitted a new drug therapy, ABBV-951, to the US Food and Drug Administration (FDA) for patients with advanced Parkinson's disease.

The therapy – which is also known as foscarbidopa/foslevodopa – focuses on motor fluctuations.

The submission is based on results from a phase 3, head-to-head, randomised and controlled clinical trial which demonstrated statistically significant improvement among patients.

Approximately 130 adult participants with Parkinson's, whose motor symptoms were no longer adequately controlled by their current medications, were enrolled in the study at 80 sites in the US and Australia.

ABBV-951 is designed to provide a first-of-its-kind, 24-hour, continuous subcutaneous delivery of carbidopa/levodopa (CD/LD). Compared to oral CD/LD, it offers the potential for improvement in motor fluctuations in patients with advanced Parkinson's.

Adverse events during the trial were non-serious, mild or moderate. There were no deaths in the ABBV-951 group, while in the oral CD/LD group, one patient died as a result of a treatment-emergent adverse event.

The most common adverse events reported – in fewer than 10% of patients in the ABBV-951 group – were erythema, pain, cellulitis, edema and dyskinesia.

The submission is also supported by results from an ongoing multi-centre, phase 3, open-label study, which is assessing the long-term safety and efficacy of the therapy.

"Advanced Parkinson's disease causes unrelenting challenges and uncertainty for patients and caregivers worldwide," said Thomas Hudson, senior vice president, research and development at AbbVie.

"We are committed to addressing the unmet needs of those affected by the disease and recognise the urgency for a new treatment that can enable better symptom control through the continuous 24-hour administration of medication."

Parkinson's disease is a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells that primarily manifests itself with tremors, muscle rigidity, slowness of movement and balance difficulty.

Patients and their healthcare providers typically share the same goal – to extend the amount of ‘on’ time – the period when symptoms are well controlled without involuntary movements.

AbbVie will continue to pursue regulatory submissions for ABBV-951 in several international markets throughout the year.