Shares of Intellipharmaceutics International Inc. (IPCI) gained momentum following the announcement of positive data from its Rexista oxycodone technology development program on Jul 15, 2013. Since the news, the shares gained 15%, ending the trading session on Friday (Jul 19) at $1.84.
On Jul 15, Intellipharmaceutics provided an update on its Rexista oxycodone development program which included – (i) results of the current stage of development and physico-chemical tests to assess abuse-deterrent properties of its Rexista oxycodone; (ii) stability studies and (iii) successful phase I study of its Rexista abuse-deterrent oxycodone, designed around its proprietary drug delivery system.
Results from the physico-chemical studies demonstrate that Rexista oxycodone when pulverized and reduced to particles should be difficult and time consuming to syringe or inject and also inefficient to snort or inhale. Rexista oxycodone should be difficult to abuse through crushing, chewing or licking; and should not "dose dump," or instantaneously release the entire dose of oxycodone, in the presence of ethanol over a range of concentrations. Release of oxycodone from Rexista oxycodone is likely to be slower or not instantaneous in a range of beverages and solvents; and it should be insignificant or inefficient via heating and vaporization.
Stability studies revealed that the Rexista oxycodone formulation was stable for storage even at a high temperature and relative humidity.
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.
Intellipharmaceutics carries a Zacks Rank #1 (Strong Buy). Right now, Jazz Pharmaceuticals (JAZZ) and NPS Pharmaceuticals, Inc. (NPSP) look equally attractive with a Zacks Rank #1. Avanir Pharmaceuticals, Inc. (AVNR) is also well positioned with a Zacks Rank #2 (Buy).
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