Access to Parkinson’s medication likely by summer: Supernus official
Newly approved therapy Onapgo can make patients’ life 'more predictable'
Supernus Pharmaceuticals is on track to make Onapgo (apomorphine hydrochloride) — its newly approved medication for treating motor fluctuations in advanced Parkinson’s disease — available to patients in the U.S. by summer.
That’s according to Jonathan Rubin, MD, chief medical officer at Supernus, who said that, by consistently controlling daily off episodes — periods when medications wear off and symptoms worsen — Onapgo has the potential to benefit patients and “can help to make their days with Parkinson’s more predictable.”
Rubin, who spoke with Parkinson’s News Today about the therapy’s approval in a written Q&A, noted that “the mission to get Onapgo into the hands of patients has become personal for many” on the Supernus staff. The company expects the medication, approved earlier this month by the U.S. Food and Drug Administration (FDA), to be available in the second quarter of this year, or by the end of June, along with a comprehensive patient support program, Rubin said.
While other formulations of apomorphine were already available in the U.S., the FDA decision made Onapgo the first subcutaneous, or under-the-skin, apomorphine infusion device to be approved for the continuous management of motor fluctuations, or off times between doses of standard Parkinson’s therapies.
Supernus will launch support program with Parkinson’s medication
Patients in Europe and other regions have had such an option — a medication widely sold as APO-go — available to them since the 1990s.
“When we heard that the FDA approved Onapgo, we were incredibly excited that we could deliver on our promise to patients and uphold our company’s mission to improve the lives of people living with diseases of the central nervous system,” Rubin said.
Diseases of the central nervous system are conditions that affect the brain or spinal cord. Parkinson’s is a neurodegenerative disease marked by the progressive loss of nerve cells in the brain that produce a signaling chemical called dopamine.
Patients are treated with levodopa or other therapies intended to increase dopamine levels in the brain. However, such treatment is typically marked by off periods.
“Over time, the benefits of these medications diminish, and patients report alternating states between ‘on’ when medication is working, and ‘off’ when it’s not working optimally,” Rubin said. “These disruptions cause significant inconsistency in a patient’s day, so consistent daily control of off time is key to improving how patients feel and move.”
Onapgo is a proven treatment option for those experiencing daily disruptions from off time.
According to Rubin, “Onapgo is a proven treatment option for those experiencing daily disruptions from off time.”
The therapy’s active ingredient is apomorphine, which works by mimicking dopamine’s activity in the brain. Apokyn, also marketed by Supernus, is an injectable formulation of apomorphine that’s been approved in the U.S. as an on-demand treatment for motor fluctuations since 2004.
Previously known as SPN-830, Onapgo instead delivers apomorphine continuously via a portable electronic pump, for about 16 hours a day. This steady supply of the medication could allow for better symptom control, while also requiring fewer injections, according to the company.
In the Phase 3 TOLEDO study (NCT02006121) that backed Onapgo’s approval, the participants — all of whom had been living with Parkinson’s for at least three years — experienced significant reductions in off time and a corresponding increase in good on time. On time is any period without uncontrolled movements, known medically as dyskinesia.
Onapgo provides options to surgical treatment, medical officer says
Until the advent of these new therapies, patients whose off episodes were not well controlled may have had to consider more invasive treatment options, such as deep brain stimulation.
With Onapgo’s approval, Rubin says that “patients in the U.S. who are not responding well to their current treatment regimen will now have the option of using a small and lightweight wearable device to deliver a continuous apomorphine infusion without resorting to invasive surgical treatments.”
While this medication was generally well tolerated in clinical studies, Rubin noted that patients should always keep in mind that there can be side effects with Onapgo. As with all treatments, patients considering the therapy should talk with their doctors about whether it’s the right choice for them.
In recognition that “care for Parkinson’s extends beyond treatment,” Rubin noted that Supernus will offer a comprehensive support program called Circle of Care that will be available to all Onapgo users at the time the therapy is launched.
The program, designed to “provide comprehensive and continuous support from the moment Onapgo is prescribed,” will involve experts to support patients in various aspects of the therapy’s use, according to Rubin.
That will include clinical nurse navigators to give patients personalized education and support, as well as hub coordinators to help with things like specialty pharmacy coordination, understanding insurance coverage, and reimbursement support, Rubin noted.
Supernus has not yet released pricing information for Onapgo.
About the Author
