Intellipharmaceutics International Inc.
) 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
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
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).
NPS Pharmaceuticals, Inc.
look equally attractive with a Zacks Rank #1.
Avanir Pharmaceuticals, Inc.
) is also well positioned with a Zacks Rank #2 (Buy).
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