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news.Medivation has announced that based on its end-of-Phase II meeting with the FDA, the company plans to begin a pivotal confirmatory Phase III trial of Dimebon for mild-to-moderate Alzheimer's disease in the second quarter of 2008.
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The FDA informed Medivation that the company’s previously completed trial conducted in Russia can be used as one of the two pivotal studies required to support the approval of Dimebon to treat mild-to-moderate Alzheimer’s disease, as long as a significant proportion of the sites in the confirmatory Phase III trial are located in the US.
The Phase III clinical trial will enroll approximately 525 patients with mild-to-moderate Alzheimer’s disease at sites in the US, Europe and South America. Patients will be randomized to one of three treatment groups: Dimebon 20mg three times per day (TID), Dimebon 5mg TID, and placebo. Patients will be treated for six months and may not be taking any other Alzheimer’s disease drugs. The primary endpoints are the Alzheimer’s disease assessment scale – cognitive subscale (ADAS-cog) and the Clinician’s interview-based impression of change plus caregiver interview (CIBIC-plus). Medivation expects to complete the pivotal confirmatory Phase III trial and apply for marketing approval in 2010.
David Hung, president and CEO of Medivation, said: “We are now a Phase III company with clear regulatory guidance on the pivotal trials required to seek marketing approval for Dimebon in the US.”