What You Need to Know
The recent approval of Onapgo (apomorphine hydrochloride) by the FDA marks a significant milestone in Parkinson’s disease treatment, particularly for those experiencing motor fluctuations. This drug-device combination provides a continuous subcutaneous infusion of apomorphine, offering an alternative to conventional therapy methods.
Understanding Apomorphine Pump Therapy
Apomorphine pump therapy is a treatment option for Parkinson’s patients experiencing significant motor fluctuations that are not adequately controlled by oral medications. Motor fluctuations refer to the alternation between “ON” (when medication is working) and “OFF” states (when symptoms return). This therapy aims to provide a steady delivery of medication, reducing the severity of “OFF” episodes.
A recent study has identified the device-reported percentage of time in the “ON” state as the best-performing objective metric for differentiating patients recommended (APO) from those non-recommended (non-APO) for apomorphine pump therapy. This metric takes into consideration both “OFF” time and dyskinesia, providing a more accurate assessment of patient suitability for the therapy.
The TOLEDO Trial: Validating Apomorphine’s Efficacy
One of the most critical studies supporting apomorphine infusion therapy is the TOLEDO trial. This multicenter, randomized, placebo-controlled study was conducted across 23 European hospitals to evaluate the efficacy and safety of continuous subcutaneous apomorphine infusion in patients with advanced Parkinson’s disease experiencing severe motor fluctuations despite optimized oral therapy.
Key Findings from the TOLEDO Trial
- The trial enrolled 107 patients who received either apomorphine infusion or a placebo saline infusion over 12 weeks.
- The primary endpoint measured the absolute change in daily “OFF” time.
- Results showed a 2.47-hour reduction in daily “OFF” time for patients receiving apomorphine, compared to a 0.58-hour reduction in the placebo group.
- The mean difference of 1.89 hours per day was statistically significant (p=0.0025).
- While generally well tolerated, six patients discontinued due to treatment-related adverse effects, primarily infusion site reactions and somnolence.
Following the double-blind phase, an open-label extension assessed the long-term safety and efficacy of apomorphine infusion.
- 84 patients continued therapy, and 70.2% completed the study.
- At week 64, the mean reduction in “OFF” time was 3.66 hours, and the increase in “ON” time without dyskinesia was 3.31 hours.
- The mean daily levodopa-equivalent dose decreased by 543 mg.
FDA Approval of Onapgo
On February 4, 2025, the FDA approved Onapgo as the first subcutaneous apomorphine infusion device for motor fluctuations in advanced Parkinson’s disease. This approval followed previous rejections in 2022 and 2024, where the FDA requested additional data on product quality and device function.
Key Takeaways from the FDA Approval Process
- Onapgo delivers apomorphine continuously, providing a non-invasive alternative to frequent injections.
- Late-stage trials confirmed it reduces daily “OFF” episodes by over two hours compared to placebo.
- Supernus Pharmaceuticals expects Onapgo to be available in the U.S. by Q2 2025.
What This Means for Parkinson’s Patients
The approval of Onapgo represents a major step forward in Parkinson’s treatment, particularly for those with advanced disease. Patients who struggle with motor fluctuations and do not qualify for deep brain stimulation (DBS) now have a viable alternative therapy.
Considerations for Patients and Physicians
- Monitoring “ON” and “OFF” time is crucial for determining suitability for apomorphine therapy.
- Physicians should assess cognitive function, as severe psychiatric conditions may contraindicate therapy.
- Adverse effects such as infusion site reactions should be managed proactively.
As research on neurodegenerative disease advances, integrating objective digital biomarkers into treatment plans may further refine therapy selection and effectiveness.
AI-generated medical content is not a substitute for professional medical advice or diagnosis; I hope you found this blog post informative and interesting. www.parkiesunite.com by Parkie
Leonardo Prompt: A photorealistic image of a Parkinson’s patient using the newly FDA-approved Onapgo device, a small, modern, wearable subcutaneous pump attached discreetly to their abdomen. The patient, appearing in their late 60s, is sitting in a cozy living room, engaging in daily activities like reading a book with a relaxed expression, demonstrating improved mobility and reduced Parkinson’s symptoms. The environment is warmly lit, emphasizing comfort and medical advancement.
Taglines:
- Breakthrough Relief, Steady Control
- Onapgo: A New Era for PD
- Continuous Care, Renewed Life
Negative Prompt: Malformed limbs, extra limbs, mutated hands, disfigured face, bad anatomy, malformed hands, Text, lettering, captions, generating images with text overlays