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TORONTO, ON / ACCESSWIRE / October 10, 2018 / Intellipharmaceutics International Inc. (NASDAQ: IPCI; TSX : IPCI) (“Intellipharmaceutics” or the “Company”), a biologic aggregation specializing in the research, development and accomplish of atypical and all-encompassing controlled-release and targeted-release articulate solid dosage drugs, today appear that it has completed the analytic allotment of its Category 2 and 3 animal corruption accountability studies for its Oxycodone ER (oxycodone hydrochloride extended-release formulation) artefact applicant to abutment its abuse-deterrent characterization claims for both the articulate and intranasal avenue of administration.

The Company’s new biologic appliance (“NDA”) for an abuse-deterrent adaptation of Oxycodone ER was accustomed for filing by the U.S. Aliment and Biologic Administering (“FDA”) in February 2017. The acquiescence was accurate by Category 1 abuse-deterrent studies (to abutment intravenous corruption bridle characterization claim) and cardinal pharmacokinetic studies that approved that the artefact is bioequivalent to OxyContin® (oxycodone hydrochloride extended-release) and can be administered with or after a meal (i.e., no aliment effect). A collective affair of the Anesthetic and Analgesic Biologic Articles Advisory Committee and Biologic Safety and Risk Management Advisory Committee of the FDA captivated in July 2017 bidding a admiration to assay added abstracts for Oxycodone ER that may be acquired from animal corruption abeyant studies for the articulate and intranasal routes of administration.

The corruption accountability studies for the intranasal avenue of corruption commenced in May 2018 with accountable screening, while the studies to abutment abuse-deterrent characterization claims for the articulate avenue of corruption commenced in June 2018. The analytic allotment of both studies has now been completed. Bioanalytical samples and statistical assay for such studies are pending. An amend on the after-effects will be provided already the assay is complete.



The FDA accepted our appeal for an addendum to February 28, 2019 to resubmit our NDA for Oxycodone ER beneath area 505(b)(2) of the U.S. Federal Food, Biologic and Cosmetic Act. However, we plan to resubmit the appliance after this year.

There can be no affirmation that Intellipharmaceutics will not be appropriate to conduct added studies for Oxycodone ER, that the FDA will accept any of the Company’s requested abuse-deterrent characterization claims or that the FDA will ultimately accept the NDA for the auction of Oxycodone ER in the U.S. market, or that it will anytime be auspiciously commercialized.

About Intellipharmaceutics

Intellipharmaceutics International Inc. is a biologic aggregation specializing in the research, development and accomplish of atypical and all-encompassing controlled-release and targeted-release articulate solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release biologic commitment belvedere that can be activated to a advanced ambit of absolute and new pharmaceuticals. Intellipharmaceutics has developed several biologic commitment systems based on this technology platform, with a activity of articles (some of which accept accustomed FDA approval) in assorted stages of development. The Aggregation has abbreviated new biologic appliance (“ANDA”) and NDA 505(b)(2) biologic artefact candidates in its development pipeline. These accommodate the Company’s abuse-deterrent oxycodone hydrochloride connected absolution conception (“Oxycodone ER”) based on its proprietary nPODDDS™ atypical Point Of Divergence Biologic Commitment System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules).

Cautionary Statement Apropos Forward-Looking Advice

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Certain statements in this certificate aggregate “forward-looking statements” aural the acceptation of the United States Private Balance Litigation Reform Act of 1995 and/or “forward-looking information” beneath the Balance Act (Ontario). These statements include, after limitation, statements bidding or adumbrated apropos our expectations apropos our plans, goals and milestones, cachet of developments or expenditures apropos to our business, affairs to armamentarium our accepted activities, and statements apropos our partnering activities, bloom authoritative submissions, strategy, approaching operations, approaching banking position, approaching sales, revenues and profitability, projected costs and bazaar assimilation and risks or uncertainties accompanying to our adeptness to apprehend any advancing allowances from our contempo about-face banal breach and our adeptness to apparatus our plan of acquiescence with the Nasdaq connected advertisement standards. In some cases, you can analyze advanced statements by analogue such as “appear,” “unlikely,” “target,” “may,” “will,” “should,” “expects,” “plans.” “plans to,” “anticipates”, “believes,” “estimates,” “predicts,” “confident,” “prospects,” “potential,” “continue,” “intends,” “look forward,” “could,” “would,” “projected,” “goals,” “set to,” “seeking”; or the abrogating of such agreement or added commensurable terminology. We fabricated a cardinal of assumptions in the alertness of our advanced statements. You should not abode disproportionate assurance on our advanced statements, which are accountable to a aggregation of accepted and alien risks and uncertainties that could account absolute results, approaching affairs or contest to alter materially from those declared in or adumbrated by the advanced statements. Risks and uncertainties apropos to us and our business can be begin in the “Risk Factors” area of our latest anniversary advice form, our latest Anatomy 20-F, and our latest Anatomy F-3 (including any abstracts basic a allotment thereof or congenital by advertence therein), as able-bodied as in our reports, accessible acknowledgment abstracts and added filings with the balance commissions and added authoritative bodies in Canada and the U.S., which are accessible on www.sedar.com and www.sec.gov. The advanced statements reflect our accepted angle with account to approaching contest and are based on what we accept are reasonable assumptions as of the date of this certificate and we abandon any ambition and accept no obligation or responsibility, except as appropriate by law, to amend or alter any advanced statements, whether as a aftereffect of new information, approaching contest or otherwise.

Trademarks acclimated herein are the acreage of their corresponding holders.

Unless the ambience contrarily requires, all references to “we,” “us,” “our,” “Intellipharmaceutics,” and the “Company” accredit to Intellipharmaceutics International Inc. and its subsidiaries.

CONTACT INFORMATION

Company Contact: Intellipharmaceutics International Inc.Andrew PatientChief Banking Officer 416.798.3001 ext. 106 investors@intellipharmaceutics.com

Investor Contact: ProActive Capital Kirin Smith 646.863.6519 ksmith@pcgadvisors.com

SOURCE: Intellipharmaceutics International Inc.

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

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View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

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View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

View antecedent adaptation on accesswire.com: https://www.accesswire.com/513891/Intellipharmaceutics-Announces-Completion-of-the-Clinical-Component-of-Category-2-and-3-Human-Abuse-Liability-Studies-for-Oxycodone-ER

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