Whatever the stereotype of a hobbyist cross-stitcher may be, Ray Henderson does not fit it. Henderson, 65, is an electrical engineer who specializes in control systems for Los Alamos National Laboratory. But he finds the methodical, exacting process of stitching square after tiny square with colored thread to be soothing, and its colorful, tactile products to be a satisfying complement to the detailed digital renderings he produced in his day job.

Over the years, he finished cross-stitched Christmas-stockings for his three grown children and his first grandchild, each taking hundreds of hours to complete. Then came grandchild number two, a baby girl named Esmeralda. She would not, it seemed, be getting a cross-stitched stocking of her own.

Henderson was diagnosed with Parkinson’s disease in mid-2018. By 2021, it eroded his fine-motor skills to below the cross-stitching threshold while he was working on Esmeralda’s stocking. Parkinson’s also affected his walking, overall energy, and the quality of his sleep. What had been “on-off” cycles – “on” being when his carbidopa-levodopa pills helped him feel like his old self – were now off-on cycles: The three hours “on” and one hour “off” between doses had degraded to the opposite. He had to schedule trips to the supermarket near his home north of Longmont to be back home before the drugs wore off.

“I’d think, OK, I’ll take my medicines now, I’m going to be ‘on’ in 20-30 minutes, and I can go to the grocery store,” Henderson said. “If I can get the grocery store done in 30 minutes, I can get home before I go ‘off’.”

Special delivery via Vyalev

No longer, thanks to a medical device that the U.S. Food and Drug Administration approved on Oct. 17. Known as AbbVie-951 when Henderson started using it two years ago, it now goes by Vyalev. It’s a pump made by AbbVie that dispenses a formulation of foscarbidopa and foslevodopa continuously through a small needle rather than in discrete, pill-delivered doses. Carbidopa and levodopa combine to deliver the neurotransmitter dopamine to Henderson’s brain – dopamine that Parkinson’s disease robs its hosts of. A lack of dopamine is complicit in many Parkinson’s symptoms.

University of Colorado School of Medicine movement-disorders neurologist Dr. Drew Kern has led three clinical trials and is continuing to run three long-term extension studies of the AbbVie device at the CU School of Medicine’s Clinical and Translational Research Center (CTRC) site at UCHealth University of Colorado Hospital (UCH) on the Anschutz Medical Campus. Henderson joined the third trial, taking his first dose on Nov. 1, 2022. He and five other Kern patients remain on the pump via their trial participation.

Kern says AbbVie developed a new, pH-neutral liquid formulation of carbidopa/levodopa for the device, but it’s the consistent delivery of these proven drugs that makes the difference. He likened the subcutaneous needle-pump combination to the insulin pumps that have revolutionized diabetes care. The idea of continuous medication delivery wasn’t a new idea in Parkinson’s treatment, he says. AbbVie had already developed a carbidopa-levodopa gel to be gradually dispensed directly into the gut. But that approach has drawbacks.

“It’s a feeding tube, and it’s cumbersome, and it requires surgery,” Kern said. “A lot of Coloradans don’t want to walk around with a feeding tube if they’re hiking, camping, and everything else.”

Continuous carbidopa-levodopa flow for an ‘even keel’

The Vialev pump dispenses the foscarbidopa/foslevodopa liquid through a needle affixed with a small bandage – no surgery required. The pH-neutral formulation was important in minimizing skin irritation, Kern says. The bandage and its injection site get moved to a new spot every two to three days.

The pump dispenses 10 milliliters of the drug combination from a syringe inside the device. Henderson replaces it once a day. Within set parameters, he can adjust the dosage with what amount to “high,” “medium,” and “low” settings. There’s also a button he can push to dispense an additional dose once an hour if he feels he needs a boost.

“It puts me on an even keel,” Henderson said. “I’m still doing things I couldn’t do without the pump.”

He feels good, he says. He has no problem getting up at night or in the morning – previously a struggle because his oral medications had worn off. He’s not watching the clock when he runs errands. His wife Kathy doesn’t have to cut his food for him. He walks Tillie, their cocker spaniel, a mile every day.

“I don’t really have ‘off’ times anymore,” Henderson said. “I’m pretty much ‘on’ all the time, 24/7, though some ‘ons’ are better than others.”

Pump is a ‘game changer’ 

Kern is bullish on the device’s potential to serve patients with more advanced Parkinson’s disease (pills generally work well until the disease progresses, he says). The pump enables fine-tuned dosing that’s hard to achieve with pills. It can provide an option for patients who aren’t interested in or, given their age or health status, makes deep-brain stimulation neurosurgery too high-risk.

“By the time somebody’s five or 10 years into the disease course, there’s a high likelihood they would benefit from this treatment,” Kern said.

Kern sees the AbbVie pump as a “game changer” for many among the 1 million people with Parkinson’s disease in the United States. He says Vyalev’s FDA approval has already brought inquiries from fellow neurologists, and that he expects general neurologists as well as primary care physicians to ultimately prescribe the pump.

The benefits to Henderson have been clear: improved sleep, improved mobility, and improved fine-motor skills. Having the pump as a constant companion took some getting used to, he said, and it weighs on him at times. But he no longer must set an iPhone reminder to take carbidopa-levodopa pills every four hours – reminders he sometimes missed, paying the price in more “off” time. The pump also keeps running at night, avoiding gaps during sleep.

As a long-term Vyalev user, he and Kathy have become expert in changing the location of the cannula to different spots in his abdomen, doing so in about five minutes. He likens the cannula to a thumbtack, its nine-millimeter (0.35-inch) needle which delivers the medication. Switching out the medication syringe also takes about five minutes, he says. The pump reminds him when it’s time to do that and, occasionally, replace the pump’s battery. He has learned that, if skin near the cannula seems irritated, to move it to another spot.

Henderson knows that the AbbVie pump isn’t a cure – as with carbidopa-levodopa pills, it manages symptoms, not the underlying Parkinson’s disease.

“The Parkinson’s is still there. I still have all the things that go with Parkinson’s, he said. “But what I don’t have is the ‘off’ time of having to deal with Parkinson’s.”

Among the fruits of Henderson saying “on”? An exquisitely stitched heirloom for a granddaughter he loves.