The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday.
The regulator approved Vyalev, also known as Produodopa, a 24-hour infusion injected below the skin that treats motor fluctuations in patients with advanced Parkinsons.
“For too long, the Parkinson’s community has had limited treatment options for advanced disease,” Dr. Robert A. Hauser, professor of neurology at the University of South Florida said in a press release. “Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required.”
The company said that its phase 3 trials showed that superior improvement in motor fluctuations compared to an oral drug. AbbVie also said that the drug provided more “on” time where symptoms were relieved with less “off” time when symptoms return.
The company said that adverse reactions among the approximately 70 people who received the drug in the 130-person trail were mild or moderate and included infusion site events, hallucinations, and dyskinesia.
What is Parkinson’s disease?
Parkinson’s disease is a progressive movement disorder that occurs when brain cells that make dopamine stop working or die, according to the Michael J. Fox Foundation.
The Mayo Clinic says that symptoms of the disease include:
- Tremors
- Slowed movement
- Rigid muscles
- Poor posture and balance
Late-stage symptoms include slurred speech and an inability to create facial expressions, according to the clinic.
Approximately 1 million people in the United States and 6 million people suffer from the disease, according to the Fox Foundation. A 2022 study found that nearly 90,000 older Americans are afflicted with the disease each year.
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