The U.S. Food and Drug Administration (FDA) has given a green light to Titan Pharmaceuticals to begin a first-in-human clinical trial testing an implant that provides continuous release of ropinirole to treatParkinsons signs and symptoms. In the open-labelPhase 1/2 trial (NCT03250117), which is nowrecruiting, roughly 20 Parkinsons disease patients taking levodopa along with oral ropinirole (marketed as Requip) will be switched to the subdermal, or under the skin, implant for three months. They will continue using levodopa. This study will measure how muchropiniroleis released in the blood during the three months, and evaluate possibleside effects caused by the new drug delivery route. It will also look for evidenceof treatment efficacy through changes inthe severity of Parkinsons disease in participants. The trial will take place at three or more U.S. sites, although only one in Michigan is currently registered. New treatments that offer continuous delivery of medication providing non-pulsatile stimulation of dopamine receptors in the brain appear to have some advantages over oral formulations, Dr.Aaron Ellenbogenof the Michigan Institute of Neurological Disorders said in a press release. The ProNeura implants with ropinirole could potentially offer an important treatment option for continuous drug delivery that overcomes the fluctuating drug levels associated with … Continue reading
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