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news.Durect Corporation and Voyager Pharmaceutical Corporation have completed enrollment for the recently approved study for the Durin-based leuprolide acetate product candidate for Alzheimer's disease.
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The FDA accepted Voyager’s investigational new drug application (IND) and clinical protocol in late December 2004. This unique formulation is being used in the present study in healthy volunteers to evaluate the product candidate’s bioavailability, as well as determine its safety and tolerability following administration.
Voyager has completed the enrollment and initial dosing of all screened subjects necessary to complete the trial.
“We are pleased with the recruiting and enrollment efficiency of our clinical site,” said Patrick Smith, president and CEO of Voyager, “and fully expect our upcoming meeting with the FDA will result in an approval of our plans to proceed with our pivotal studies during the second half of 2005.”
Durect’s Durin biodegradable implant technology is a platform for short- and long-term parenteral drug delivery lasting in duration from weeks to six months. Voyager owns a broad-based patent covering the use of hormone drug leuprolide acetate and other compounds for the treatment of Alzheimer’s disease.