New FDA Approved Drugs for Parkinson’s Disease

Parkinson’s disease (PD) remains a progressive neurodegenerative disorder affecting millions worldwide. For decades, the mainstay of treatment has been the administration of levodopa and its combinations, along with dopamine agonists and other adjuvant medications.

However, as the disease advances, many patients experience fluctuations in motor control, commonly referred to as “on–off” phenomena, dyskinesia, and other debilitating side effects that significantly impair quality of life.

In the past few years, scientists and drug manufacturers have raised the bar with a number of newly approved medications aimed at filling these gaps, providing patients with more predictable symptom control and fewer complications.

In this article, we examine the latest developments including new formulations and delivery technologies, that are revolutionizing Parkinson’s disease treatment.

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The Limitations of Existing Treatments

Traditionally, PD treatment has centered on oral levodopa/carbidopa formulations (such as Sinemet) that help restore dopamine levels in the brain.

While these drugs are highly effective in the early stages of the disease, they are not without drawbacks.

Over time, the short half-life of levodopa leads to fluctuating plasma levels, causing periods when the medication “wears off” (off-time) and episodes of dyskinesia.

Dopamine agonists like ropinirole and pramipexole have been used as alternatives or adjuncts, but they, too, can cause side effects such as nausea, sleepiness, hallucinations, and impulse control disorders.

These limitations have spurred the development of innovative therapies that provide more consistent dopaminergic stimulation, reduce motor fluctuations, and offer improved quality of life for those in later stages of Parkinson’s disease.

Recently Approved Medications for Parkinson’s Treatment

Extended-Release Oral Formulations: Crexont

One of the most recent breakthroughs is Crexont, a reformulated, longer-acting version of the classic levodopa/carbidopa pill.

Approved in August 2024, Crexont is designed to address the intermittent dosing problems associated with conventional oral medications.

How Does It Work?

Crexont uses an extended-release mechanism to maintain steadier levels of levodopa in the bloodstream, thereby reducing the fluctuations that cause off-time and dyskinesia.

This formulation reduces the number of daily doses required and helps provide more consistent symptom control throughout the day.

Benefits

• Patients experience longer periods during which their symptoms are well controlled.
• Reduced Dosing Frequency improves adherence and is generally more convenient.
• Extended-release technology minimizes the peaks and troughs of dopamine levels.

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Continuous Infusion Therapies: Vyalev and Produodopa

For patients with advanced Parkinson’s, intermittent oral dosing often fails to deliver a steady dopamine supply.

Two newly approved continuous infusion therapies, Vyalev and Produodopa, are changing that scenario.

Vyalev (AbbVie’s 24-Hour Infusion)

Approved in October 2024, Vyalev represents a significant advancement for advanced PD patients.

Mechanism and Delivery:

Vyalev is a combination of levodopa and carbidopa administered through a subcutaneous pump for continuous, 24-hour infusion. It better replicates the natural release of dopamine compared to oral medication, thus lowering motor fluctuations.

 Benefits:

• Clinical trials have shown that Vyalev can add approximately three extra hours of on-time without troublesome dyskinesia. [Ref]
• The steady infusion prevents the “wear-off” effect that plagues oral formulations.

Common Side Effects:

While generally well tolerated, patients may experience infusion site reactions and mild hallucinations.

Produodopa (Foslevodopa/Foscarbidopa)

Another innovative approach is Produodopa, a formulation consisting of foslevodopa/foscarbidopa. Approved in Europe and the United Kingdom in 2024, this therapy also utilizes a continuous subcutaneous infusion system.

Like Vyalev, Produodopa also offers continuous infusion and minimizes fluctuations in dopamine levels, leading to fewer off periods and more consistent symptom management.

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Drug-Device Combinations – Onapgo

In early 2025, Onapgo a drug-device combination by Supernus Pharmaceuticals received FDA approval. Onapgo is designed specifically for patients experiencing significant motor fluctuations.

How does it work?

Onapgo delivers apomorphine, a potent dopamine agonist, continuously via a subcutaneous pump.

Unlike traditional apomorphine injections (which must be administered every two hours), Onapgo provides a convenient and steady dosage.

Clinical data suggest Onapgo can reduce off-time by more than two hours compared to placebo. [Ref]

Moreover, Onapgo may have fewer skin nodules and injection site reactions than some other infusion treatments.

Comparing New Therapies with Existing Treatments:

Key Benefits and Side Effects of Newly Approved Parkinson’s Medications

Comparing of Newly Approved Parkinson’s Medications:

Clinical Perspectives on New Treatments for Parkinson’s Disease

Enhanced Symptom Control

The main advantage of these newly approved therapies lies in their ability to provide continuous dopaminergic stimulation.

This is especially critical for advanced PD patients, who typically have less endogenous dopamine storage capacity due to neuronal loss.

Improved Quality of Life

For most patients, the variability inherent in oral levodopa regimens is not only clinically difficult—they significantly impact daily living.

Extended-release products and continuous infusion therapy smooth out these fluctuations, leading to more predictable motor performance.

Patients have fewer interruptions in their daily routine, better sleep quality, and a general improved quality of life.

Safety and Tolerability

Although infusion therapies do have side effects—such as local skin reactions and, in some cases, hallucinations—the overall benefit–risk profile is favorable compared with the complications arising from the long-term use of high-dose oral levodopa.

Efficacy

Past and current reviews conducted by health technology assessment agencies such as CADTH and patient organization surveys have reflected that patients taking continuous infusion therapies (Vyalev and Produodopa), stated notable improvements in the quality of their lives.

The patients experienced relief from the fluctuations of motors and an added relief from fewer pills that have to be consumed every day. [Ref]

A study published in the European Journal of Neurology noted that while traditional combinations are defined by a heavy pill burden and volatile control of symptoms, the new continuous infusion treatments have a more favorable profile both in effectiveness and in patient convenience. [Ref]

Conclusion

New formulations and continuous infusion therapies like Crexont, Vyalev, Produodopa, and Onapgo—provide smoother, more consistent dopamine delivery and reduce motor fluctuations compared to traditional oral medications.

Although infusion systems require pumps and may cause local side effects, their benefits in long-term symptom control are significant.

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