IntelliPharmaCeutics completes part of Oxycodone study
INTELLIPHARMACEUTICS INTERNATIONAL Inc. 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 for an abuse-deterrent version of Oxycodone ER was accepted for filing by the U.S. Food and Drug Administration 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 (that is, 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 the company’s request for an extension to Feb. 28, 2019, to resubmit the company’s NDA for Oxycodone ER under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. However, the company plans 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 commercialized.
About IntelliPharmaCeutics International Inc.
IntelliPharmaCeutics 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 and NDA 505(b)(2) drug product candidates in its development pipeline.
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