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Clinical results for Intellipharmaceutics' CR pregabalin

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Canadian drug delivery company Intellipharmaceutics ($IPCI) has announced Phase I results for its nongeneric controlled-release formulation of pregabalin, the active ingredient in Pfizer's ($PFE) Lyrica. In the trial involving 14 people, Intellipharmaceutics' pregabalin XR had equivalent bioavailability to three-times-daily Lyrica. Intellipharmaceutics is planning further Phase I trials next year.

Lyrica is approved for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia (the pain after shingles), spinal cord injury and fibromyalgia, but any drug that needs to be taken three times a day runs the risk of missed and forgotten doses. A once-daily dose could improve compliance and improve the outcomes for patients and healthcare providers, but there is currently no controlled-release version available.

Pfizer's controlled-release formulation of Lyrica has hit the buffers somewhat lately. While top-line analysis of the Phase III fibromyalgia study showed that Pfizer's controlled-release drug was more effective than placebo, the epilepsy trial missed its endpoints. A third study is ongoing in postherpetic neuralgia.

In other news, Intellipharmaceutics' Rexista oxycodone, an abuse- and alcohol-resistant controlled-release formulation, is moving into clinical trials in its final formulation, with results expected next year.

"Our first proof-of-concept trial of Rexista oxycodone yielded bioavailability comparable to OxyContin. We plan to repeat these trials using our final formulation," commented Isa Odidi, Intellipharmaceutics CEO.

- read the press release

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