Intellipharmaceutics Announces Completion of the Clinical Component of Category 2 and 3 Human Abuse Liability Studies for Oxycodone ER
ACCESS Newswire
TORONTO, ON / ACCESSWIRE / October 10, 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 completed the clinical part of its Category 2 and 3 human abuse liability studies for its Oxycodone ER (oxycodone hydrochloride extended-release formulation) product candidate to support its abuse-deterrent label claims for both the oral and intranasal route of administration.
The Company's new drug application ("NDA") for an abuse-deterrent version of Oxycodone ER 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 abuse liability studies for the intranasal route of abuse commenced in May 2018 with subject screening, while the studies to support abuse-deterrent label claims for the oral route of abuse commenced in June 2018. The clinical part of both studies has now been completed. Bioanalytical samples and statistical analysis for such studies are pending. An update on the results will be provided once the analysis is complete.
The FDA granted our request for an extension to February 28, 2019 to resubmit our NDA for Oxycodone ER under section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. However, we plan to resubmit the application later this year.
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.
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™ 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™ 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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CONTACT INFORMATION
Company Contact: Intellipharmaceutics International Inc. Andrew Patient Chief Financial Officer 416.798.3001 ext. 106 investors@intellipharmaceutics.com
