A USF researcher led a clinical trial for a new Parkinson’s drug

A new drug that can prevent the symptoms of Parkinson’s disease longer than existing drugs has just hit the market.

And a researcher and professor from the USF Health Center for Parkinson’s Disease and Movement Disorders played a key role in this drug getting approval from the US Food and Drug Administration.

Robert A. Hauser, who teaches in the Department of Neurology at the University of South Florida, designed and served as the principal investigator in a clinical trial to prove the drug’s efficacy and safety. A study, published in the American Journal of the American Medical Association last year, found that the drug is effective in preventing the debilitating symptoms of the disease such as tremors, difficulty speaking and immobility, proving to more effective than current medicine even with a small daily dose.

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

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

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

The 13-week study involved 630 people aged 40 and over diagnosed with Parkinson’s and was conducted at 105 academic and clinical centers in the United States and Europe. The patients, who were randomly selected, were given either Crexont or the latest Parkinson’s drug. Whether it was the doctor or the patient or the medicine they were giving or taking.

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

That can mean long-term relief of symptoms such as tremors but also slowness, stiffness and difficulty walking and speaking.

“It can take 30 minutes or an hour for regular medications to kick in and it can only take two or three hours,” Hauser said. “They find that they are still on this path.”

The long-term success of the drug is due to slow-release capsules that include a mucoadhesive polymer that enables the ingredients of the tablets to stick for a long time to the lower stomach where they are inserted into the body, Hauser said.

About a million people in the United States have Parkinson’s and 90,000 new cases occur each year, according to the Parkinson’s Foundation.

Although it is not necessarily fatal, it greatly affects the quality of life. As it progresses, it destroys many of the dopamine-producing neurons in the body. In addition to tremors, it can lead to depression, anxiety, apathy, hallucinations, seizures and sleep problems. The Centers for Disease Control and Prevention ranked complications from this disease as the 14th leading cause of death in the United States.

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Future Parkinson’s drugs may include infusions that provide continuous relief, Hauser said. There is also ongoing research into early detection of the disease, focusing on potential warning signs including decreased sense of smell and sleep disturbances.

Since most people who develop the disease do so after the age of 60, there is also hope that future drugs could slow or delay its progression by a decade or more, with an effective way to reduce symptoms in the last part of people’s lives.

“If we can push those out for 30 years, we’ll be ahead of the game,” Hauser said.

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Learn more:

Crexont is available with a prescription. People with Parkinson’s disease should talk to their doctor.

Manufacturer Amneal Pharmaceuticals has not released pricing information but is making efforts to make the new drug available and affordable in its early days when insurers may not provide coverage. Savings can be found with CoverMyMeds. Amneal also operates a patient assistance program.

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