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news.Antares Pharma has announced that its partner, Jazz Pharmaceuticals, plans to initiate a Phase III clinical trial for a central nervous system product candidate, JZP-7, which utilizes Antares's Advanced Transdermal Delivery system to deliver ropinirole.
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The product candidate provides an effective, once-daily treatment for moderate to severe restless legs syndrome (RLS). One pharmacokinetic (PK) study has been completed and data from a second PK study is being analyzed.
In the first study, doses were well tolerated locally and systemically for five days. In the second study, subjects were successfully escalated to higher doses and there were no serious adverse events. Final analysis of the safety data is still ongoing. The Phase III trial is planned to begin in the fourth quarter of 2008.
Jack Stover, president and CEO of Antares, said: “Advancing to Phase III with JZP-7 clearly demonstrates the versatility of our Advanced Transdermal Delivery system and its application in this important therapeutic area of CNS. In addition, we anticipate receiving milestone payments as the product progresses, as well as milestones upon launch and royalties.”