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."
- Pharmaceuticals & Drug Trials
- Phase I clinical trial