TORONTO, ON / ACCESSWIRE / December 5, 2019 / Intellipharmaceutics International Inc. (OTCQB:IPCIF 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, announced today that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration ('FDA') has been scheduled for January 15, 2020 to review the Company's New Drug Application ('NDA') for Aximris XRTM abuse-deterrent oxycodone hydrochloride extended-release tablets.
The original NDA was accepted for filing by the FDA on February 2, 2017. A complete response letter (CRL) was issued by the FDA on September 25, 2017 and the Company's resubmission of the NDA for Aximris XRTM in response to the CRL was accepted for review by the FDA on February 28, 2019. Aximris XRTM is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
There can be no assurance that the outcome of the FDA Advisory Committee meeting for Aximris XR will be positive, that the Company will not be required to conduct further studies for Aximris XRTM, that the FDA will ultimately approve the NDA for the sale of Aximris XRTM in the U.S. market, or even if it is approved, 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 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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Unless the context otherwise requires, all references to 'we,' 'us,' 'our,' 'Intellipharmaceutics,' and the 'Company' refer to Intellipharmaceutics International Inc. and its subsidiaries.
Intellipharmaceutics International Inc.
Chief Financial Officer
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SOURCE: Intellipharmaceutics International Inc.
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