A Louisville company has been chosen to market a new drug just approved by the Food and Drug Administration to treat Parkinson’s disease.
US Worldwide Meds, a specialty pharmaceutical company, will market Xadago, the first drug given clearance in a decade for sufferers of the neurological disorder that causes tremors and difficulties with movements.
With the aging of baby boomers in the U.S. and abroad, neurological diseases such as dementia and Parkinson’s are expected to afflict more people in coming decades. Roughly 50,000 people are diagnosed in the U.S. with the disease, and about 1 million Americans have Parkinson’s. It affects about 10 million worldwide.
The FDA reported that tremors and other symptoms of the disease worsen over time, but the standard treatment, levodopa, has been shown to diminish in effectiveness. Xadago is an add-on treatment that is intended for use when a person’s regular medicines aren’t working well. The pill was tested in two six-month studies with about 1,200 patients taking levodopa.
Adding Xadago to levodopa reduced involuntary muscle movement and patients who took the new drug also had better control of movement compared to groups that took levodopa and “dummy” pills, the FDA said.
Milan, Italy-based Newron Pharmaceuticals, which has a U.S. subsidiary in Morristown, New Jersey, developed Xadago.
Newron’s partner is US Worldwide Meds LLC, at 4441 Springdale Road in eastern Louisville. Company officials told the Associated Press that the drug’s list price without insurance will be $670 for a 30-day supply of either the 50- or 100-milligram dose.
Side effects can include falls, involuntary movement, nausea and insomnia. People with severe liver problems or those taking opioid painkillers and some antidepressants, the FDA said.
“We are thrilled by the FDA’s approval of Xadago and are excited to have a key role in the introduction of a new medicine for Parkinson’s disease. We will now accelerate our U.S. launch preparations to get Xadago to Parkinson’s patients in need of new treatment options,” P. Breckinridge “Breck” Jones, the company’s chief executive and founder, said in a release by Business Wire.
By Grace Schneider