October 18, 2024 – The FDA has approved a brand new injectable treatment for adults with advanced Parkinson's disease called Vyalev (also often called Produodopa). This recent option is designed to assist individuals who have difficulty managing their symptoms with traditional medication or surgery.
Parkinson's disease is a condition that affects movement and gets worse over time. This happens when the brain stops producing enough dopamine, a chemical that helps control things like movement, memory and mood. Without enough dopamine, Parkinson's patients experience symptoms reminiscent of tremors, slow movements, stiff muscles and problems with balance. These symptoms can change throughout the day, with periods when symptoms are under control (called “on times”) and periods when symptoms recur and make it tougher to maneuver (called “off times”).
For individuals with advanced Parkinson's disease, managing these symptoms becomes even tougher and, in some cases, their movements may grow to be uncontrollable (called dyskinesia), making on a regular basis tasks way more difficult.
What is Vyalev?
Vyalev combines two medications that help increase dopamine levels within the brain and keep symptoms under control for a full 24 hours. Instead of taking pills throughout the day, this treatment is run via a small pump that repeatedly injects the medication under the skin. The company that makes Vyalev, AbbVie, says that after some training, patients or their caregivers can easily learn how one can use the pump.
This recent treatment offers a substitute for oral medications, which may grow to be less effective as Parkinson's disease progresses. Robert Hauser, MD, a neurologist and Parkinson's specialist, said Vyalev offers patients the chance to administer their symptoms across the clock without the necessity for surgery.
What the research shows
Vyalev's FDA approval was based on a study of 130 adults with advanced Parkinson's disease within the United States and Australia. The study found that patients who took Vyalev had longer “on” time (when their symptoms were well controlled) than those that continued their regular pills. On average, people taking Vyalev had 2.7 hours more “on time” every day, in comparison with slightly below 1 hour for people taking oral medications.
Most patients experienced an improvement of their symptoms throughout the first week of treatment, and these improvements were sustained throughout the duration of the 12-week study.
What you must learn about unintended effects
Like most medications, Vyalev could cause unintended effects. The most typical include skin reactions on the injection site, involuntary movements (dyskinesia), and hallucinations (seeing or hearing things that usually are not there). For anyone desirous about trying Vyalev, it can be crucial to refer to their doctor and be sure that their healthcare provider is aware of some other medications or supplements they’re taking.
AbbVie also conducted an extended study to see how secure and effective Vyalev is over time, and the outcomes of this 52-week study are promising.