Americans will soon have access to an infusion device that provides round-the-clock effective relief of Parkinson’s disease. The US FDA this week approved the sale of the treatment, which harnesses innovative technology to make managing the condition easier and more impactful, will be available towards the end of 2025.
The treatment, which will be sold under the name Onapgo, is essentially a subcutaneous – under the skin – device that allows for continuous infusion of the dopamine agonist apomorphine hydrochloride to reduce ‘off’ episodes. These episodes are periods during the day and night when lepodova medication wears off between doses and adverse motor-function symptoms (dyskensia) become amplified. In trial, Onapgo – formerly known as SPN-830 – significantly reduced these daily off episodes by an average of 2.47 hours, compared to the placebo treatment (0.58 hours).
“The approval of Onapgo (SPN-830) is a significant milestone in Parkinson’s disease management,” Kelly Papesh, executive director of the Aossociation of Movement Disorder Advanced Practice Providers, recently told NeurobiologyLive. “This therapy has the potential to be a game-changer, helping us provide more individualized and effective care to those living with Parkinson’s. Additionally, as more therapies like this are approved, it reinforces the need for continued innovation in drug development, particularly in delivering more consistent symptom control without relying solely on oral medications.”
Developed by Supernus Pharmaceuticals, Onapgo does away with the hassle of needing to administer constant injections. Onapgo also doesn’t need to be metabolized in the gut first, which ideally gives patients more control over their treatment and its efficacy.
“As Parkinson’s disease progresses, levodopa treatment often becomes less effective at delivering consistent motor control in part due to GI dysmotility, variable absorption of oral medication, and the resulting pulsatile stimulation of dopamine pathways in the brain,” said Dr Stuart Isaacson, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, who was also one of the clinical trial investigators for Onapgo. “With Onapgo, the continuous infusion of apomorphine directly stimulates postsynaptic dopamine receptors with no metabolic conversion needed. In addition, the subcutaneous delivery of apomorphine bypasses the GI tract and enters the brain, which can allow for more predictable symptom improvement.”
The drug itself was first approved in 2004 under the brand name Apokyn, in the form of an injection pen that could be used up to five times a day. The newly approved infusion device can provide better symptom management without the need for surgery. The approval of the treatment will also be rolled out with an education program for healthcare professionals.
More than 10 million people around the globe – a million in the US alone – are living with the progressive neurodegenerative disorder, and the uncontrolled movements seen in dyskinesia have a significant impact on quality of life and independence.
“Continuous subcutaneous apomorphine infusion already has a proven and established 30-year history in Europe, where it has helped deliver more consistent control of motor fluctuations for thousands of patients,” said Dr Rajesh Pahwa, professor of Neurology at the University of Kansas School of Medicine, and another trial investigator. “In a clinical trial in Europe, patients treated with Onapgo experienced a significant reduction in daily ‘off’ time and a similar significant increase in ‘good on’ time.
“Today’s approval of Onapgo means patients in the US who are not responding well to their current treatment regimen, including levodopa, will 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,” Pahwa added.
The trial results showed that the treatment was well tolerated overall, despite half a dozen patients dropping out due to worse side effects. In general, though, there were no unexpected safety concerns.
“As the motor symptoms of Parkinson’s disease worsen over time, patients report alternating states between ‘on’ when their medication is working, and ‘off’ when it’s not working optimally,” said Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance. “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. For many, continuous treatment options like Onapgo can help to make days with Parkinson’s more predictable.”
Supernus Pharmaceuticals is a US-based biopharmaceutical company that’s focused on developing novel treatments for diseases that affect the central nervous system. It has invested more than four years in getting FDA approval for Onapgo.
Late last year, drug company AbbVie received FDA approval for its pump-based system that delivers a continuous supply of carbidopa and levodopa, the standard frontline treatment for Parkinson’s disease.
Source: Supernus Pharmaceuticals
