The administration for food and medicines in the United States (FDA) approved Onapgo, the first and only wearing subcutaneous infusion device, intended for patients with advanced Parkinson’s disease.
The new device will help patients with advanced PHOTO PEKINSON: Shutterstock
According to Medicalxpress, the announcement was made by Supernus Pharmaceuticals, which developed the product.
Onapgo is a small, lightweight device designed to provide continuous treatment throughout the day, ensuring a more constant control of motor fluctuations. It imitates dopamine to help manage Parkinson’s symptoms, providing a constant dose and continues under the skin.
The efficiency and safety of Onapgo were evaluated in a 3 -week clinical phase clinical study and included 107 patients. The results showed a significant reduction in the time spent off (when the drugs have no optimal effect) by 2.6 hours a day, compared to only 0.9 hours for the placebo. Patients have also experienced a significant increase in Good On time (when the symptoms are optimally controlled), 2.8 hours compared to 1.1 hours for placebo. These improvements have been observed since the first week of treatment and have been maintained throughout the study.
Experts in the field believe that this device could have a significant impact on the quality of life with advanced Parkinson’s patients. “As the motor symptoms of Parkinson’s disease worsen, patients report alternating states, when drugs work, and off, when they have no optimal effect. These unpredictable changes are extremely disturbing, which is why a constant control of the off time is essential to improve patient condition. For many of them, continuous treatment options, such as Enapgo, can make the days with Parkinson said Andrea Merriam, CEO of Parkinson & Movement Disorder Alliance in Phoenix.
The most common side effects reported by patients who used Onapgo were nodules at the scene of infusion, nausea, excessive drowsiness, skin irritation, headaches and insomnia.
According to the manufacturer, the device will be available in the second quarter of 2025, and its launch will be supported by a team of experts and a large training program.
