BUZZ-IntelliPharmaCeutics International Inc: Accelerated development likely for lead drug

Thu May 21, 2015 10:11am EDT
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** Canadian drugmaker's U.S.-listed shares up 16.2 pct at $3.14; Toronto-listed shares up 16.9 pct at C$3.85

** Company says U.S. FDA does not need it to conduct late-stage of its abuse deterrent opioid painkiller if it can demonstrate bioequivalence between the drug, Rexista Oxycodone XR, and the commonly used painkiller, Oxycontin

** FDA's decision paves way for potentially accelerated development plan for Rexista Oxycodone XR

** Company in March demonstrated bioequivalence in three early-stage trials

** Says on Thursday that it is unlikely be required to conduct late-stage studies in light of these prior results

** Says it expects to submit application test Rexista Oxycodone XR in humans in the next 6-12 months

** Rexista Oxycodone XR is the company's non-generic extended release formulation to manage moderate to severe pain when a round-the-clock treatment is required

** Up to Wednesday's close, U.S.-listed stock had risen nearly 20 pct this year; Toronto-listed shares had risen nearly 27 pct in the same period