Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

doogdilinger, I agree you with 100%

An ADF which prevents oral abuse and overdose would stand alone in the class and would be a game-changer. Likewise, I think the generic pipeline of IPCI is very attractive, as is the share structure. But I am confused about a few things and so far have had limited success in finding further info, so maybe you could help me.

The technology which limits oral abuse called PODRAS was announced by PR in August 2014:

http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=868259

August 28, 2014
Intellipharmaceutics Augments Its Rexista(TM) Oxycodone Development Program With Novel Overdose Deterrence Technology

TORONTO, Aug. 28, 2014 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced an enhancement of its Rexista™ abuse-deterrence technologies with a significant improvement designed to prevent overdose when more pills than prescribed are swallowed intact. Intellipharmaceutics' new platform technology is branded PODRAS™ (Paradoxical OverDose Resistance Activating System).

I cannot find any information to explain the mechanism of PODRAS. As such an avid supporter, I'm hoping you can point me in the direction of an explanation of the PODRAS technology and how it works. Clearly it is an "add-on" feature to an older formulation Rexista, as above. So, my question is this: was bioequivalence with OxyContin proven with old formualtion or with the new Rexista with PODRAS? The PR announcing bioequivalence in March 2015 makes no mention of PODRAS or prevention of oral abuse:

http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=903948

Rexista™ Oxycodone XR

Rexista™ Oxycodone XR is a non-generic extended release formulation intended for the management of moderate to severe pain when an around-the-clock analgesic is required. The formulation is intended to present a significant barrier to tampering when subjected to various forms of anticipated physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently co-administered with alcohol. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting and snorting.

Now compare this to the Fast Track PR May 2015:

http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=914770

May 26, 2015
FDA Grants Fast Track Designation for Intellipharmaceutics Rexista(TM) Oxycodone XR Incorporating PODRAS[/b](TM) Technology

TORONTO, May 26, 2015 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration ("FDA") has reviewed the Company's request for Fast Track designation for its abuse deterrent Rexista™ Oxycodone XR (Oxycodone HCl) extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System ("PODRAS™") and has concluded that it meets the criteria for Fast Track designation.

...

About Rexista™ Oxycodone XR incorporating PODRAS™

The Company's Rexista™ Oxycodone XR product candidate has been further enhanced with its proprietary PODRAS™ delivery technology intended to reduce the likelihood of oral abuse when more pills than prescribed are swallowed intact. Preclinical studies of Rexista™ Oxycodone XR suggest that if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected. However, if the prescribed number of pills is swallowed, the drug release should be as expected.

Finally, the "Acceleration" PR, just one week before the fast track PR says this:

http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=914386

May 21, 2015
Intellipharmaceutics Intends to Accelerate its Rexista(TM) Oxycodone XR Development Program on the Basis of Positive Feedback from the FDA

TORONTO, May 21, 2015 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration ("FDA") provided the Company with notification regarding its Investigational New Drug Application ("IND") submission for Rexista™ Oxycodone XR (Abuse Deterrent oxycodone hydrochloride) extended release tablets. The notification from the FDA stated that the Company will not be required to conduct Phase III studies if bioequivalence to Oxycontin™ is demonstrated.

What does this mean? I thought Rexista already demonstrated bioequivalence.



doogdilinger, I like IPCI for multiple reasons, but I must hesitate due to the lack of any explanation of how PODRAS works. I also hesitate because the precise wording of the PR's is suggestive that bioequivalence was documented with the old version and not the augmented version with PODRAS. If, in fact, PODRAS has not yet acheived bioequivalence and has not passed any HAL studies, it seems very difficult to believe that FDA submission will be coming later this year. Any links or documentation that you could point me to that describes PODRAS and clarifies which formulation demonstrated bioequivalence would be greatly appreciated.

Cross-posted on ELTP