Intellipharmaceutics International Inc. (IPCI)

[bhtaylor29]

Have a question for the board. I notice that on the website for this company as well as articles on several sites, there is no Phase 2 being listed anywhere for Rexista. A phase one is mentioned and then its Phase 3. asked this question on the latest seeking alpha article but no one answered. What am I missing? Is it because its a generic that a phase 2 isnt required? Are these FDA clinical trials? Or is this a typo?
Qoute from Zacks:
The data from the phase I study of Rexista oxycodone in comparison with Purdue Pharma LP’s OxyContin was positive. The data revealed that a single dose of 40 mg Rexista oxycodone was bio-comparable to 40 mg OxyContin. OxyContin is approved for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Intellipharmaceutics intends to seek a Special Protocol Assessment from the FDA for assistance in conducting a pivotal phase III study on Rexista oxycodone. Intellipharmaceutics also has plans to look for a licensing partner for the phase III studies.

Additional phase I studies are expected by the fourth quarter of 2013, and Intellipharmaceutics expects to commence phase III studies by the first half of 2014.


Thanks