USF researcher led clinical trial for new Parkinson’s medication

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

And a researcher and professor from the USF Health Parkinson’s Disease and Movement Disorders Center played a critical role in the drug obtaining its approval from the U.S. Food and Drug Administration.

Robert A. Hauser, who teaches in the Department of Neurology at the University of South Florida, designed and served as principal investigator on a clinical trial to prove the drug’s effectiveness and safety. The study, which was published in the American Journal of the American Medical Association last year, found that the drug works longer at preventing the disease’s debilitating symptoms like tremors, speech difficulty and immobility, proving more effective than current medications even with fewer daily doses.

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

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

“Its’ a very big deal,” he said. “Patients can take fewer doses per day and get more continuous benefits throughout the day.”

The 13-week study involved 630 people aged 40 and older diagnosed with Parkinson’s and took place at 105 academic and clinical centers in the United States and Europe. Patients, chosen at random, were given either Crexont or current Parkinson’s medication. Neither the clinician nor the patient nor which medication they were administering or taking.

Patients on Crexont, also known as IPX203, were given three doses a day compared to five doses for those taking current medication. Despite fewer doses, the new drug prevented symptoms for roughly 1.5 hours longer, a 70% improvement, Hauser said.

That could mean extended relief from symptoms like tremors but also slowness, stiffness and difficulty walking and speaking.

“It may take 30 minutes or an hour for standard medication to kick in and it may only last two or three hours,” Hauser said. “They find that they’re on this roller coaster.”

The drug’s longer lasting effectiveness is due to slow-release capsules including a mucoadhesive polymer that enables the compounds in the tablets to attach for longer to the lower intestine where they are absorbed into the body, Hauser said.

Roughly one million people in the United States have Parkinson’s with 90,000 new diagnoses occurring each year, according to the Parkinson’s Foundation.

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

Future Parkinson’s medications may include infusions that provide continuous relief, Hauser said. There is also ongoing research into how to detect the disease earlier that is focusing on potential warning signs including decreased sense of smell and kicking out in sleep.

Since the majority of those who develop the disorder do so after age 60, there is also hope that future medication can delay or slow its progression for a decade or more, effectively limiting symptoms for the last part of people’s lives.

“If we could push those off for 30 years, we’d be getting ahead of the game,” Hauser said.

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Crexont is available by prescription. People with Parkinson’s disease should consult with 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 may not yet provide coverage. Savings may be available through CoverMyMeds. Amneal also operates a patient assistance program.

For more information go to www.crexont.com/support-resources/