Intellipharmaceutics Announces Resubmission of New Drug Application to the U.S. FDA for its Oxycodone ER
TORONTO, ON / ACCESSWIRE / March 4, 2019 / 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 resubmitted its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for its Oxycodone ER product candidate.
The Company’s NDA for an abuse-deterrent version of Oxycodone ER was initially accepted for filing by the FDA in February 2017. Intellipharmaceutics resubmitted the NDA in response to a Complete Response Letter (“CRL”) received from the FDA, which provided certain recommendations and requests for information. The FDA granted us an extension to February 28, 2019 to resubmit our NDA under section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act and the Company has now met this deadline.
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 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).
Cautionary Statement Regarding Forward-Looking Information
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Trademarks used herein are the property of their respective holders.
Unless the context otherwise requires, all references to “we,” “us,” “our,” “Intellipharmaceutics,” and the “Company” refer to Intellipharmaceutics International Inc. and its subsidiaries.
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CONTACT INFORMATION
Company Contact:
Intellipharmaceutics International Inc.
Greg Powell
Chief Financial Officer
416.798.3001 ext. 106
investors@intellipharmaceutics.com
Investor Contact:
ProActive Capital
Kirin Smith
646.863.6519
ksmith@pcgadvisory.com
SOURCE: Intellipharmaceutics International Inc.
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