October 18, 2024 – The FDA has approved a brand new injectable treatment for adults with advanced Parkinson's disease called Vyalev (also often known as 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 akin to 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 constantly injects the medication under the skin. The company that makes Vyalev, AbbVie, says that after some training, patients or their caregivers can easily learn the way to use the pump.
This recent treatment offers an alternative choice to 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 need to find out about uncomfortable side effects
Like most medications, Vyalev could cause uncomfortable side effects. The most typical include skin reactions on the injection site, involuntary movements (dyskinesia), and hallucinations (seeing or hearing things that should not there). For anyone enthusiastic about trying Vyalev, it's important to consult with their doctor and be certain that their healthcare provider is aware of another 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.