United States – AbbVie announced Thursday that the Food and Drug Administration has approved a drug for the treatment of late-stage Parkinsons.
The regulator endorsed Vyalev, also referred to as Produodopa, a 24-hour infusion injected just under the skin to help patients with advanced Parkinsons manage motor fluctuations, as reported by USA Today.
Positive Phase 3 Trial Results
To back the claim, the company has pointed to its phase 3 trials, which demonstrated a superior improvement in motor fluctuations compared to an oral drug. AbbVie also said that the drug gave more time when symptoms were eased than when symptoms recurred.
The company said that side effects among the 70 patients receiving the drug in the 130-patient trial were mainly mild to moderate and included infusion site reactions, psychotic disorder, psychotic disorder, hallucinatory disorder, and dyskinesia.
Disorder Explained
Parkinsons disease is a movement disorder that manifests when the brain produces less or no dopamine, the Michael J. Fox Foundation elaborated.
Symptoms of the disease include:
Tremors
Slowed movement
Rigid muscles
Poor posture and balance
The late symptoms include improper speech and inability to make facial expressions, as mentioned in the clinic.
The Scope of the Disease
About one million people in the USA and six millions people in the world suffer from this disease, according to the Fox Foundation. According to research taken in 2022, nearly 90,000 senior citizens are affected with the disease yearly, as reported by USA Today.