USF researcher led clinical trial for new Parkinson’s drug

A new drug that can stave off Parkinson’s disease symptoms longer than current drugs has just hit the market.

And a researcher and professor at USF Health’s Parkinson’s Disease and Movement Disorders Center played a key role in getting the drug approved by the U.S. Food and Drug Administration.

Robert A. Hauser, a professor in the Department of Neurology at the University of South Florida, designed and served as principal investigator on a clinical trial to demonstrate the drug’s efficacy and safety. The study, which was published in the American Journal of the American Medical Association last year, found that the drug works longer to prevent debilitating symptoms of the disease, such as tremors, slurred speech and immobility, and is more effective than current medications even at lower daily doses.

Parkinson’s is a neurodegenerative disorder that primarily affects dopamine-producing neurons in the brain.

The new drug could reduce or eliminate the so-called “off time,” the period when the drug wears off and symptoms return but it is too soon to take the next dose, Hauser said.

“It’s a big step forward,” he said. “Patients can take fewer doses per day and get more sustained benefits throughout the day.”

The 13-week study involved 630 people aged 40 or older with Parkinson’s and was conducted at 105 academic and clinical centers in the United States and Europe. Patients were randomly assigned to receive either Crexont or their current Parkinson’s medication. Neither the physician nor the patient were informed of which medication they were taking or receiving.

Patients taking Crexont, also known as IPX203, received three doses a day, compared with five doses for those taking the current drug. Despite receiving fewer doses, the new drug prevented symptoms for about 1.5 hours longer, a 70% improvement, Hauser said.

This could mean long-term relief from symptoms such as tremors, but also slowness, stiffness and difficulty walking and speaking.

“Standard medication can take 30 minutes to an hour to kick in and may only last two or three hours,” Hauser said. “They feel like they’re on a roller coaster.”

The drug’s longer-lasting effectiveness is due to slow-release capsules that include a mucoadhesive polymer that allows the tablets’ compounds to stick longer in the lower intestine, where they are absorbed by the body, Hauser said.

According to the Parkinson’s Foundation, approximately one million people in the United States have Parkinson’s and 90,000 new diagnoses occur each year.

While it is not necessarily fatal, it drastically affects quality of life. As it progresses, it destroys more dopamine-producing neurons in the body. In addition to tremors, it can cause depression, anxiety, apathy, hallucinations, constipation and sleep disorders. The Centers for Disease Control and Prevention ranked complications from the disease as the 14th most common cause of death in the U.S.

Hauser said future Parkinson’s medications could include infusions that provide continuous relief. There is also ongoing research into how to detect the disease early, focusing on potential warning signs such as decreased sense of smell and kicking during sleep.

Since most people develop the disorder after age 60, there is also hope that future drugs could delay or slow its progression for a decade or more, effectively limiting symptoms during the later part of people’s lives.

“If we could put them off for 30 years, we’d be moving forward,” Hauser said.

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More information:

Crexont is available on prescription. People with Parkinson’s disease should consult their specialist.

Manufacturer Amneal Pharmaceuticals has not released pricing details, but is making efforts to make the new drug available and affordable during its initial period, when insurers cannot yet offer coverage. Savings may be available through CoverMyMeds. Amneal also operates a patient assistance program.

For more information, visit www.crexont.com/support-resources/