A new medication, Crexont (IPX203), offering extended relief from Parkinson's disease symptoms has been approved by the U.S. Food and Drug Administration (FDA). The development and approval of Crexont involved critical contributions from Dr. Robert A. Hauser, Director of the Parkinson’s Disease and Movement Disorder Center at the University of South Florida (USF) Health, who designed and led the pivotal clinical trial.
Clinical Trial Results
The 13-week clinical trial, published in the American Journal of the American Medical Association, involved 630 participants aged 40 and older diagnosed with Parkinson’s disease across 105 academic and clinical centers in the United States and Europe. Patients were randomly assigned to receive either Crexont or existing Parkinson’s medications. The study found that patients on Crexont experienced symptom control for approximately 1.5 hours longer compared to those on standard medications, representing a 70% improvement, despite taking fewer doses (three doses of Crexont versus five doses of the standard immediate-release formulation).
"Patients can take fewer doses per day and get more continuous benefits throughout the day," said Dr. Hauser.
Mechanism of Action
Crexont's prolonged effectiveness is attributed to its unique slow-release capsules, which include a mucoadhesive polymer. This polymer enables the compounds in the tablets to adhere to the lower intestine for an extended period, facilitating more consistent absorption into the body.
Impact on Parkinson's Patients
Parkinson’s disease, a neurodegenerative disorder affecting approximately one million people in the United States with 90,000 new diagnoses each year, primarily impacts dopamine-producing neurons in the brain. This leads to symptoms such as tremors, stiffness, slowness of movement, and difficulties with speech. Crexont aims to mitigate the “off time” experienced by patients when the effects of standard medications wear off between doses.
Future Directions
Ongoing research is exploring new approaches to Parkinson’s treatment, including continuous infusion therapies and methods for earlier disease detection, focusing on potential warning signs like a diminished sense of smell and sleep disturbances. Future medications may also focus on delaying or slowing the progression of Parkinson’s disease.
Crexont is available by prescription, and manufacturer Amneal Pharmaceuticals is working to ensure affordability and access, including patient assistance programs.
