AbbVie's new drug therapy, Vyalev, for Parkinson's disease, incorporates innovations from University of Kansas pharmaceutical chemist Valentino Stella. Approved by the U.S. Food and Drug Administration (FDA) in October 2024, Vyalev aims to improve the lives of the estimated one million Americans living with this progressive neurological condition.
The drug is administered subcutaneously via a wearable pump, delivering a consistent dosage of levodopa (L-dopa)/carbidopa. This method is designed to mitigate the symptom fluctuations experienced by Parkinson's patients, particularly the 'on-off' periods related to medication timing. According to AbbVie, Phase 3 clinical trials demonstrated that patients on Vyalev experienced superior improvement in motor fluctuations, with increased 'on' time without troublesome dyskinesia and decreased 'off' time, compared with oral CD/LD IR.
Stella's Contribution
Valentino Stella, university distinguished professor emeritus of pharmaceutical chemistry at the University of Kansas, played a crucial role in the development of Vyalev. He was involved in the discovery of forms of L-dopa and carbidopa that could be concentrated for infusion. "I was involved in a few early subsequent stages," Stella said. "If I remember correctly, I was involved in some issues that came up, but only very early on. After that, it was all done by AbbVie — they did the chemistry that ended up making these compounds pure."
Clinical Trial Outcomes
The FDA approval was based on a successful Phase 3, 12-week study. The findings indicated that Vyalev led to a significant increase in 'on' time, representing periods of optimal motor symptom control, and a decrease in 'off' time, when symptoms return. This improvement is clinically significant, as it addresses a major challenge in Parkinson's disease management: maintaining consistent symptom control throughout the day.
Stella's Legacy
Vyalev is the seventh FDA-approved drug for which Stella is credited as an inventor. His previous contributions include the anti-cancer agent Velcade, Fosphenytoin for epileptic seizures, Viread for HIV and chronic hepatitis B, Fospropofol, and Captisol, a solubilizer used in numerous injectable drugs, including Remdesivir during the COVID-19 pandemic. Stella reflected on the impact of his work, stating, "It's not the accolades, it's not the strokes you get, it's not the promotion or tenure — it's the impact you make on people's lives."
