TORONTO, ON / ACCESSWIRE / May 8, 2018 / Intellipharmaceutics International Inc. (NASDAQ: IPCI; 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 commenced its Category 2 and 3 human abuse liability studies for the Company's Oxycodone ER product candidate to support its abuse-deterrent label claims for the intranasal route of administration.
"This is a very important step towards resubmission of our NDA for Oxycodone ER," commented Dr. Isa Odidi, CEO of Intellipharmaceutics. "We have continued to work with the FDA since receipt of the Complete Response Letter late last year and we refined our studies based on their recommendations. We have a very clear plan to complete the remaining work and feel confident that we will meet our goal of resubmission later this year."
The Company's new drug application ("NDA") for an abuse-deterrent version of Oxycodone ER (oxycodone hydrochloride extended-release formulation) was accepted for filing by the U.S. Food and Drug Administration ("FDA") in February 2017. The submission was supported by Category 1 abuse-deterrent studies (to support intravenous abuse deterrent label claim) and pivotal pharmacokinetic studies that demonstrated that the product is bioequivalent to OxyContin® (oxycodone hydrochloride extended-release) and can be administered with or without a meal (i.e., no food effect). A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA held in July 2017 expressed a desire to review additional data for Oxycodone ER that may be obtained from human abuse potential studies for the oral and intranasal routes of administration.
The Company has now begun the abuse liability studies for the intranasal route of abuse. The planned studies to support abuse-deterrent label claims for the oral route of abuse are scheduled to commence within the next few weeks. Both studies are expected to take several months to complete. The intranasal abuse liability study is being conducted by Altasciences Clinical Research based in Montreal.
There can be no assurance that Intellipharmaceutics will not be required to conduct further studies for Oxycodone ER, that the FDA will approve any of the Company's requested abuse-deterrent label claims or that the FDA will ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.
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™ 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 Oxycodone ER formulation based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules).
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Intellipharmaceutics International Inc.
Chief Financial Officer
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SOURCE: Intellipharmaceutics International Inc.
Released May 8, 2018