- July 5, 2018
- Posted by: PharmaScroll
Titan Pharmaceuticals announced that the independent Data Safety Monitoring Board (“DSMB”) for the company’s Phase 1/2 trial of its ropinirole implant intended for the treatment of the signs and symptoms of idiopathic Parkinson’s disease has completed a review of the data from the first cohort of patients and recommended that the trial continue with enrollment of the second cohort of patients.
“We appreciate the DSMB’s recommendation to continue the study and evaluate the pharmacokinetic profile, safety and tolerability of our ropinirole implant, however, we have decided to temporarily postpone enrollment of the second cohort of patients in this study,” said Titan’s President and CEO, Sunil Bhonsle. “Our overriding priority over the next few months is to focus our resources on driving the commercial success of Probuphine implant, the first product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure. Nevertheless, we remain very committed to adding value for our stockholders based on achievements with Probuphine and our other ProNeura-based products, such as our ropinirole implant. To that end, we intend to resume enrolling patients in this Phase 1/2 trial as resources allow.”
Ropinirole is a dopamine agonist currently available in daily or more frequently dosed oral formulations for the treatment of Parkinson’s disease symptoms and restless leg syndrome. It is commonly used in conjunction with L-dopa to help control serious motor complications and dyskinesias that frequently occur in patients after several years of L-dopa treatment. Clinical studies have shown that these side effects are associated with fluctuating medication levels that occur with oral formulations. Titan’s ropinirole implant, which was developed utilizing its ProNeura drug delivery technology, is designed for the long-term, continuous delivery of ropinirole HCL for the treatment of signs and symptoms of Parkinson’s disease. Continuous delivery of ropinirole could potentially minimize the serious motor complications experienced by some patients on oral daily dosed formulations of the medication.
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News Source: Titan Pharmaceuticals Website
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