Oct. 18, 2024 -- The FDA has approved a new injectable treatment for adults with advanced Parkinson’s disease called Vyalev (also known as Produodopa). This new option is designed to help people who are having trouble managing their symptoms with traditional medications or surgery.
Parkinson’s disease is a condition that affects movement and gets worse over time. It happens when the brain stops making enough dopamine, a chemical that helps control things like movement, memory, and mood. Without enough dopamine, people with Parkinson’s experience symptoms like tremors, slow movements, stiff muscles, and problems with balance. These symptoms can change throughout the day, with periods where symptoms are under control (known as “on” times) and periods where symptoms come back and make it harder to move (known as “off” times).
For people with advanced Parkinson’s, managing these symptoms gets even more difficult, and in some cases, their movements can become uncontrollable (called dyskinesia), which makes everyday tasks much harder.
What Is Vyalev?
Vyalev combines two drugs that help boost dopamine levels in the brain and keep symptoms under control for a full 24 hours. Instead of taking pills throughout the day, this treatment is delivered through a small pump that continuously injects the medication under the skin. The company that makes Vyalev, AbbVie, says that patients or their caregivers can easily learn how to use the pump after some training.
This new treatment offers an alternative to oral medications, which can become less effective as Parkinson’s progresses. Robert Hauser, MD, a neurologist and Parkinson’s specialist, said that Vyalev gives patients a way to manage their symptoms around the clock without needing surgery.
What the Research Shows
The FDA approval of Vyalev was based on a study of 130 adults with advanced Parkinson’s in the U.S. and Australia. The study found that patients who used Vyalev had more "on" time (when their symptoms were well controlled) than those who continued with their regular pills. On average, people using Vyalev had 2.7 more hours of “on” time each day, compared to just under 1 hour for those taking oral medication.
Most patients saw improvement in their symptoms during the first week of treatment, and those improvements continued for the length of the 12-week study.
What to Know About Side Effects
Like most medications, Vyalev can cause side effects. The most common ones include skin reactions where the injection is given, involuntary movements (dyskinesia), and hallucinations (seeing or hearing things that aren’t there). It’s important for anyone thinking about trying Vyalev to talk to their doctor and make sure their health care provider knows about any other medications or supplements they’re taking.
AbbVie also conducted a longer study to see how safe and effective Vyalev is over time, and the results from that 52-week trial are promising.
