Replies to post #12457 on Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

BondsSF, thanks for a thoughtful response.

The bioequivalence required only has to do with Oxycontin so the PODRAS has NOTHING to be bioequivalent to.

I contacted the company asking them if a Phase 3 will be needed with the PODRAS added and will let you know what they respond.

Without knowing the PODRAS mechanism, it is most likely to somehow activate a pro-drug oxy molecule, or less likely to somehow deactivate a standard oxy molecule. So absolutely PODRAS will have a potential effect on oxy plasma concentration and bio-equivalence of the oxy will need to be re-established. Likewise, they'll need to show it works as described when multiple tabs are taken at once. This is very finicky, and many others have tried and failed. I'm not trying to say IPCI does not have it exactly right, just that they will, without any doubt, be required to prove it. That's all I'm saying. I would greatly appreciate hearing what they have to say when they get back to you.

[WeeZuhl]

BondsSF: A better question to ask the company.

I think the better question to ask IPCI is if they are developing two different Rexista formulations. For the sake of differentiation, let’s refer to them as Rexista Legacy and Rexista PODRAS. Rexista Legacy is a mechanical barrier ADF 12 hour oxycodone formula with successful Phase 1 results and is likely undergoing Human Abuse Liabilty studies at this time. The company says it has been informed by FDA that Rexista Legacy may be able to skip Phase 3 and therefore will be ready for NDA submission within 6-12 months. The company would use revenue from FDA-approved Rexista Legacy as a non-dilutive source of funding to research and develop Rexista PODRAS, an augmented formulation of Rexista Legacy in which preclinical studies suggest it could possibly reduce oral abuse and may prevent oral overdose. Due to this unique characteristic, Rexista PODRAS fulfills an unmet medical need and was granted Fast Track status by FDA.

In my opinion, Rexista Legacy may be producing revenue within 12-18 months, and those revenues will be used to develop Rexista PODRAS. For whatever reason, the company has not been forthright about the two different Rexista development programs. If they used my terminology, the recent PR's would read as below (obviously, edits in red are added by me).


August 28, 2014

Intellipharmaceutics Augments Its Rexista(TM) Oxycodone Development Program With Novel Overdose Deterrence Technology

Preclinical studies of Rexista™ (PODRAS) suggest that, unlike other third-party abuse-deterrent oxycodone products, 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, even possibly approaching zero. However, if the prescribed number of pills is swallowed, the drug release should be as expected.

March 30, 2015

Intellipharmaceutics Reports Positive Topline Data Results from a Series of Phase I Clinical Trials of its Abuse-Deterrent Rexista(TM) (Legacy) Oxycodone XR Tablets, and files an IND for Rexista(TM) (Legacy) Oxycodone XR

Rexista™ (Legacy) Oxycodone XR

The Company recently submitted an Investigational New Drug Application ("IND") to the United States Food and Drug Administration ("FDA") for Rexista™ (Legacy) Oxycodone XR in anticipation of the commencement of Phase III clinical trials. Planning has begun for the Phase III trials that will examine the efficacy and safety of Rexista™ (Legacy) Oxycodone XR in individuals with chronic low back pain.

May 21, 2015

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

The Company believes the FDA notification is significant as it provides a basis for an accelerated development plan for its Rexista™ (Legacy) Oxycodone XR product candidate, without the need for more costly and time-consuming Phase III studies. The Company intends to file a New Drug Application ("NDA") for Rexista™ (Legacy) Oxycodone XR (Abuse Deterrent oxycodone hydrochloride) extended release tablets with the FDA within the next 6 to 12 months, although no assurance to this effect can be given. Further, there can be no assurance that the FDA will ultimately approve the NDA for sale of Rexista™ (Legacy) Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.

May 26, 2015

FDA Grants Fast Track Designation for Intellipharmaceutics Rexista(TM) (PODRAS) Oxycodone XR

In March 2015, the Company requested Fast Track designation for its novel, and potentially first-in-class, Rexista™ (PODRAS) Oxycodone XR abuse deterrent oxycodone hydrochloride extended release tablets incorporating its PODRAS™ technology platform. A basis for the request was that Rexista™ (PODRAS) Oxycodone XR has the potential to address an unmet medical need, namely the prevention, deterrence or reduction of the abuse of oxycodone HCl extended release solid oral dosage forms involving the deliberate or inadvertent oral ingestion of more intact pills or tablets than prescribed to achieve a feeling of euphoria. This is a very common and serious form of drug abuse.