Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced the U.S. Food and Drug Administration (FDA) approval of Onapgo (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). Supernus will make Onapgo available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.
“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 Rajesh Pahwa, M.D., Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System, and a clinical trial investigator for Onapgo. “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 U.S. 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.”
The approval is based on results from a Phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study (N=107) evaluating the efficacy and safety of Onapgo. 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 key secondary endpoints were the mean change in daily GOOD ON time, which was defined as ON time without troublesome dyskinesia, and Patient Global Impression of Change (PGIC).1
“Onapgo represents a novel approach for adults with Parkinson’s disease who are experiencing motor fluctuations,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “Supernus’ significant experience in CNS has fueled the success of more than eight widely recognized products in CNS and other therapeutic categories. The addition of Onapgo demonstrates our continued commitment to developing novel alternatives to manage Parkinson’s disease and other neurological conditions.”
"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 Stuart Isaacson, M.D., Director of Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, and a clinical trial investigator 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."
“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.”
About the Phase 3 Study
During the Phase 3 study, Onapgo significantly reduced the amount of daily OFF time at 12 weeks from baseline (p=0.0114), with Onapgo-treated patients (n=53) experiencing a 2.6-hour reduction compared to placebo (n=51) with 0.9 hours. The reduction in daily OFF time was accompanied by a similar significant increase in daily GOOD ON time (2.8 hours for Onapgo-treated patients compared to 1.1 hours for the placebo group; p=0.0188).1* In addition, numerically greater improvements in daily OFF time and daily GOOD ON time were seen as early as week 1 and were maintained throughout all measured timepoints. Additionally, Onapgo-treated patients more frequently reported improvement in their state of general health compared with placebo-treated patients (PGIC: 79% vs. 24%; p<0.0001). The most common adverse events (≥10% incidence) were infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia.1
About Parkinson’s disease
Nearly one million people in the U.S. and 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. Patients may also experience dyskinesia, involuntary movements that can significantly interfere with daily activities.2 The disease impacts the central nervous system (e.g., the brain and spinal cord) and the peripheral nervous system, the network of nerves that support the limbs and the organs of the body (e.g., GI system including digestion, respiration, heart function, and blood pressure).3 While there is no known cure for PD, there are treatments available to help reduce symptoms.4 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.5 PD is the second most common neurodegenerative disorder of aging and the most common movement disorder.6
USE
Onapgo is a prescription medicine used to treat motor fluctuations (OFF episodes) in adults with advanced Parkinson’s disease (PD). It is not known if Onapgo is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take Onapgo if you are:
taking certain medicines to treat nausea (ondansetron, granisetron, dolasetron, palonosetron) and alosetron. People taking ondansetron with apomorphine had very low blood pressure and lost consciousness (blacked out).
allergic to apomorphine or to any ingredients in Onapgo including sulfite. Sulfites can cause severe, life-threatening allergic reactions, especially in people with asthma.
Call your healthcare provider or get emergency help right away if you have any of the following symptoms of severe life-threatening allergic reaction:
hives • itching • rash • swelling (eyes, tongue, lips, or mouth) • chest pain • throat tightness • trouble breathing or swallowing.
Before you start using Onapgo, tell your healthcare provider about all of your medical conditions, including:
difficulty staying awake during the daytime • dizziness, fainting spells, or low blood pressure • asthma
allergies to any medicines containing sulfites • heart problems • a history of stroke or other brain problems
kidney problems • liver problems • a mental problem called a major psychotic disorder • drinking alcohol • if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. It is not known if Onapgo will harm your unborn baby or pass into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription (over-the-counter) medicines, vitamins, and herbal supplements. Onapgo and certain other medicines may affect each other and cause serious side effects.
If you take nitroglycerin under your tongue (sublingual) while using Onapgo, your blood pressure may decrease and cause dizziness. If possible, lie down before taking it and then try to continue lying down for at least 45 minutes after.
What should I avoid while using Onapgo?
https://en.wikipedia.org/wiki/Apomorphine
