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November 27, 2012
07:12 EDTIPCIIntellipharmaceutics announces results of Phase I Pregabalin trial
Intellipharmaceutics announced results of an initial Phase I clinical trial of a controlled-release pregabalin formulation and announced an update to the 2012 goals of our Rexista abuse-deterrent formulations for oxycodone, and an update to the development activities of the generic version of Focalin XR. Intellipharmaceutics completed a Phase I clinical trial on its non-generic controlled-release formulation of pregabalin XR. This was the first bioavailability study of our controlled-release pregabalin versus Lyrica in 14 subjects. The results showed that our 150 mg pregabalin XR once-a-day dosage was comparable in bioavailability to Lyrica 50 mg three-times-a-day dosage. Intellipharmaceutics' previously announced development goals for 2012 included the completion of clinical batch manufacturing of Rexista oxycodone, and the initiation of Phase I studies of Rexista oxycodone. The comapny says "We are pleased to announce our manufacture of batches under current Good Manufacturing Practices has been concluded, and we are now going into clinical trials with the manufactured batches. Preliminary Phase I data from this trial is expected in early 2013....We continue to await receipt of potential regulatory approval from the FDA for our generic version of Focalin XR. No additional information has been requested by the FDA in the last three months with regards to the abbreviated new drug application that is currently under review."
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October 22, 2014
17:19 EDTIPCIIntellipharmaceutics reports positive results from Regabatin phase 1 trials
Intellipharmaceutics provided an update on the progress of its Regabatin XR product development. Regabatin XR pregabalin extended release capsules are the company's non-generic pregabalin formulations. The company has recently conducted and analyzed the results of six phase I clinical trials involving a twice-a-day formulation and a once-a-day formulation. For formulations directed to certain indications which include fibromyalgia, the results suggested that Regabatin XR 82.5 mg twice-a-day, or BID, dosage was comparable in bioavailability to Lyrica 50 mg three-times-a-day, or TID, dosage. For formulations directed to certain other indications which include neuropathic pain associated with diabetic peripheral neuropathy, the results suggested that Regabatin XR 165 mg once-a-day dosage was comparable in bioavailability to Lyrica 75 mg BID 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, which could improve patient compliance, and therefore possibly enhance clinical outcomes. Plans are underway to initiate an investigational new drug application under the new drug application 505b2 regulatory pathway with the FDA, with a view to possible commercialization in the U.S. following the Dec. 30, 2018 expiry of the patent covering the pregabalin molecule.
October 15, 2014
16:47 EDTIPCIIntellipharmaceutics reports Q3 EPS (7c), consensus (11c)
Reports Q3 revenue $1.1M, consensus $800K.

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