HQ Team
February 5, 2024: Supernus Pharmaceuticals Inc’s injection for treating people with advanced Parkinson’s disease got a green light from the US regulator after two earlier rejections.
Onapgo (apomorphine hydrochloride) is a wearable subcutaneous infusion device that is administered using a pump that continuously delivers apomorphine, a drug used to treat what’s known as “off” episodes in Parkinson’s disease.
These episodes occur in people with Parkinson’s and manifest in symptoms such as stiffness or tremors, affecting them between doses of medication such as levodopa.
The medicine will be available in the US in the second quarter of 2025, according to a statement from Rockville, Maryland-headquartered Supernus. The company focuses on developing and commercializing products for the treatment of central nervous system diseases.
‘Continous infusion’
The approval was based on results from an end-stage trial evaluating the efficacy and safety of the medicine. The primary efficacy endpoint was the mean change in total daily “off” time assessed from baseline to the end of the 12-week treatment period based on patient diaries.
The US Food and Drug Administration’s approval will allow people “who are not responding well to their current treatment regimen, including levodopa, to now have the option of using a small and lightweight wearable device to deliver a continuous infusion without the need for an invasive surgical procedure,” said Rajesh Pahwa, MD, Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, and a clinical trial investigator for the trial.
The regulator’s nod comes less than a year after it rejected the treatment for the second time in April last year. The FDA then said it needed additional information or review time for product quality and the “master file” for the device part. The agency had rejected the device in 2022.
More than 10 million people worldwide are living with Parkinson’s disease, a progressive and chronic neurodegenerative disorder that can cause tremors, muscle rigidity, and difficulty with movement and balance.
Neurodegenerative disorder
Patients may also experience dyskinesia, involuntary movements that can significantly interfere with daily activities. The disease impacts the central nervous system and the peripheral nervous system, the network of nerves that support the limbs and the organs of the body.
Parkinson’s is the second most common neurodegenerative disorder of ageing and the most common movement disorder.
“As Parkinson’s disease progresses, levodopa treatment often becomes less effective at delivering consistent motor control in part due to gastrointestinal dysmotility, variable absorption of oral medication, and the resulting pulsatile stimulation of dopamine pathways in the brain,” said Stuart Isaacson, MD, Director of Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, and a clinical trial investigator for Onapgo.
While there is no known cure for Parkinson’s, there are treatments available to help reduce symptoms. Patients treated with mainstay regimens may experience periods of “good on” time when medication treatment is working well, or “off time” when oral levodopa no longer provides symptom benefit and motor symptoms return.
‘More predictable’
“These on-again, off-again changes are disruptive and can happen at any time, which is why consistent daily control of off time is key to improving how patients feel and move,” said Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance.
“For many, continuous treatment options like Onapgo can help to make days with Parkinson’s more predictable.”
AbbVie and Mitsubishi Tanabe Pharma are other companies in the same therapy area. In October 2024, AbbVie got the FDA nod for Vyalev, which is a continuous infusion used to treat Parkinson’s.
