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Intellipharmaceutics International Inc Announces Results Of Initial Phase I Clinical Trial Of Controlled-Release Pregabalin


Tuesday, 27 Nov 2012 07:00am EST 

Intellipharmaceutics International Inc announced the results of an initial Phase I clinical trial of a controlled-release pregabalin formulation. Intellipharmaceutics successfully completed a Phase I clinical trial on non-generic controlled-release formulation of pregabalin XR. This was the bioavailability study of controlled-release pregabalin versus Lyrica (immediate release pregabalin) in 14 subjects. The results showed that 150 mg pregabalin XR once-a-day dosage was comparable in bioavailability to Lyrica 50 mg three-times-a-day dosage. Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. A controlled-release version of pregabalin should reduce the number of doses patients take, potentially improving patient compliance, and therefore potentially improving clinical outcomes. It plans to initiate additional Phase I clinical trials in 2013.There is no controlled-release formulation on the market at this time. There can be no assurance that additional clinical trials will meet expectations, in submitting a new drug application (NDA) 505(b)(2) filing with the United States Food and Drug Administration (FDA), that the FDA will approve this product candidate for sale in the U.S. market, or that it will ever be successfully commercialized. 

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