Health Canada allows Acasti Pharma to initiate CaPre Phase II trial

Following the approval, the company expects to start a double blind, placebo controlled and randomized Phase II trial to assess the usage of CaPre for the treatment of patients with dyslipidemia.

The trial will investigate the safety and efficacy of CaPre in patients with triglyceride levels ranging from moderately high to very high, which distinguishes CaPre from prescription drug fish oils labelled only to treat patients with very high levels of triglycerides.

Acasti president Tina Sampalis said the CaPre clinical phase II program will assess direct and complementary clinical outcomes associated with cardiometabolic disorders and will be supportive of additional clinical programs in Canada and in the US.

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FDA Drafts Pharma Industry Guidance For Postmarketing Studies And ...

The U.S. Food and Drug Administration (FDA) announced in the Federal Register on April 1, 2011, the availability of a Draft Guidance for Industry titled "Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act" (the "Draft Guidance"). Comments on the Draft Guidance may be submitted at any time.

The Draft Guidance addresses the implementation of section 505(o)(3) of the federal Food, Drug, and Cosmetic Act (the "FD&C Act"), added by section 901 of the Food and Drug Administration Amendments Act of 2007. Section 505(o)(3) authorizes the FDA to require postmarketing studies and clinical trials for prescription drugs approved under the FD&C Act and biological products approved under the Public Health Service Act, either at the time of approval or postapproval if the FDA becomes aware of new safety information. "New safety information" is defined to include information about a serious risk or unexpected serious risk associated with the use of the drug, or the effectiveness of the approved risk evaluation and mitigation strategy for the drug since the last assessment.

Please see full alert below for more information.

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