( IPCI IPCI.T ) Intellipharmaceutics Submits Investigational New Drug Application to the U.S. FDA for IPCI006 (oxycodone hydrochloride immediate release) Tablets Incorporating its Abuse Deterrent and Overdose Resistant Technology
8:07 AM ET 11/27/18 Dow Jones
TORONTO, ON / ACCESSWIRE / November 27, 2018 / Intellipharmaceutics International Inc. (NASDAQ and TSX:IPCI) ("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 it has submitted an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for its oxycodone hydrochloride immediate release ("IPCI006") tablets in the 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths.
Oxycodone hydrochloride is indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
This novel drug formulation incorporates the Company's Paradoxical OverDose Resistance Activating System ("PODRAS(TM)") delivery technology and its novel Point Of Divergence Drug Delivery System ("nPODDDS(TM)") technology.
IPCI006 is designed to prevent, delay or limit the release of oxycodone hydrochloride when more intact tablets than prescribed are ingested, thus delaying or preventing overdose and allowing for sufficient time for a rescue or medical intervention to take place. It is also intended to present a significant barrier to abuse by snorting, "parachuting," injecting or smoking finely crushed oxycodone hydrochloride immediate release tablets.
The data generated from the studies conducted under this IND is expected to form part of a new drug application ("NDA") seeking FDA approval for IPCI006 tablets.
If approved, IPCI006 may be the first immediate release formulation of oxycodone hydrochloride intended to simultaneously prevent or delay overdose and prevent abuse by intranasal or intravenous routes.
The CEO of Intellipharmaceutics, Dr. Isa Odidi, said, "We believe IPCI006 not only will demonstrate the strength of our abuse-deterrent technologies, but also the value of our portfolio of oxycodone hydrochloride product candidates. We are particularly excited at the potential of having the first immediate release formulation of oxycodone hydrochloride tablets focused on presenting a barrier to abuse through overdose by taking multiple tablets, abuse through intranasal inhalation and abuse through intravenous injection - in one formulation."
According to Symphony Health Solutions Corporation, U.S. sales of oxycodone hydrochloride immediate release for the 12 months ended October 31, 2018 were approximately $710 Million (in TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalog or list prices to wholesalers and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price).
There can be no assurance that we will be successful in submitting any NDA with the FDA, that the FDA will approve the Company's IPCI006 product candidate for sale in the U.S. market or any related abuse-deterrent label claims, or that it will ever be successfully commercialized and produce significant revenue for us.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix(TM) technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has abbreviated new drug application ("ANDA") and NDA 505(b)(2) drug product candidates in its development pipeline. These include the Company's abuse-deterrent oxycodone hydrochloride extended release formulation ("Oxycodone ER") based on its proprietary nPODDDS(TM) drug delivery system (for which an NDA has been filed with the FDA), and Regabatin(TM) XR (pregabalin extended-release capsules).
