Parkinson’s drug comes to market with help of renowned University of Kansas pharmaceutical chemist

LAWRENCE — A new drug therapy for Parkinson’s disease holds promise to improve life for the estimated 1 million Americans living with the progressive neurological condition.

The drug therapy, dubbed Vyalev, is marketed by North Chicago, Illinois-based pharmaceutical firm AbbVie. But one of its inventors is University of Kansas pharmaceutical chemist Valentino Stella, who can claim a long track record of developing drugs that improve people’s lives.

Stella, university distinguished professor emeritus of pharmaceutical chemistry, served as a consultant in developing Vyalev, which is delivered subcutaneously to Parkinson’s patients through a wearable pump that’s smaller, more comfortable and effective at providing consistent dosage than previous delivery methods. The drug and its pump deliver levodopa (L-dopa)/carbidopa-based therapy with more consistency, so patients don’t have symptoms flaring and subsiding, especially following sleep.

According to Stella, he was one of the inventors who led to the discovery of forms of L-dopa and carbidopa that could be concentrated to allow for the infusion.

“I was involved in a few early subsequent stages,” he 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.”

The KU researcher said the pharma firm should be credited with shouldering the burdens and costs of bringing the drug to market.

“Apparently, they arrived at the idea of what ended up working fairly quickly. Then there’s the massive cost — probably around $1 billion — to get the drug to market,” he said. “That includes scaling it up, ensuring it’s pure and sterile, and everything else. Then, of course, there are all the clinical trials, which are the most expensive part of the process.”

Approval for the drug from the U.S. Food and Drug Administration came in October 2024, after a successful Phase 3, 12-week study.

According to drugmaker AbbVie, “Findings from the pivotal study showed patients receiving Vyalev demonstrated superior improvement in motor fluctuations, with increased ‘on’ time without troublesome dyskinesia and decreased ‘off’ time, compared with oral CD/LD IR. ... ‘On’ time refers to the periods of time when patients are experiencing optimal motor symptom control, while ‘off’ time is when symptoms return.”

For Stella, who retired in 2016 after 43 years teaching at KU, bringing to market a new drug is nothing new. Indeed, over the course of his career, Stella now has been credited as inventor of seven FDA-approved drugs, including Vyalev.

Those include anti-cancer agent Velcade; Fosphenytoin, a water-soluble form of phenytoin for major epileptic seizures; Viread, used to treat HIV and chronic hepatitis B; Fospropofol, an injectable version of an anesthetic called propofol, and two others; and Captisol, a solubilizer used to make injectable versions of anti-schizophrenic and another 20 FDA-approved drug products.

Recently, during the COVID-19 pandemic, Captisol was used in the formulation of Remdesivir, the COVID drug therapy authorized under emergency-use protocol.

Stella remembers the first time he’d learned a drug he’d invented was key to a specific patient outcome, back in the 1990s. Stella’s friend, a local surgeon, told him he’d used Stella’s first FDA-approved drug, Fosphenytoin, on a patient in the operating room.

“He slapped me on the back and said, ‘Well, we saved a life today,’” Stella said. “I said, ‘You do that every day — you’re a surgeon.’ He replied, ‘No, you and I saved a life. I had a patient on the surgical table, and she went into grand mal seizures. I was losing her because she wasn’t responding to the drug I usually use. I grabbed your drug, gave it to her, and the seizure stopped immediately. This lady’s gonna be just fine.’”

Stella said the incident was the first of many where he realized his work could be more meaningful than mere recognition received from discovering a drug.

“I walked out that evening, came home and told my wife, "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," he said.

Past helping patients, Stella said his career as a drug inventor brought additional positive side effects — it improved his skills in the classroom and the lab.

“It made me a better teacher and maybe a better researcher,” he said. “And also, the way I interacted with my graduate students improved. It’s really fun when you can get into a lecture theater and talk about a drug that you helped develop. The students listen a little bit better — it’s good. They know you’re talking about something real, not just something you read in a book half an hour before. So, yes, it’s had a big impact on my life.”