Intellipharmaceutics Meets with FDA Regarding Oxycodone ER NDA Development Program
TORONTO, ON / ACCESSWIRE / February 9, 2018 / Intellipharmaceutics International Inc. (IPCI) (IPCI) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled- and targeted-release oral solid dosage drugs, today announced that it held a meeting with the United States Food and Drug Administration (“FDA”) regarding the Company’s abuse-deterrent oxycodone hydrochloride extended release tablets (“Oxycodone ER”) product candidate.
The Company and the FDA discussed the previously announced Complete Response Letter for Oxycodone ER, including issues related to the blue dye in the product candidate. Based on the meeting, the product candidate will no longer include the blue dye. The blue dye was intended to act as an additional deterrent if Oxycodone ER is abused and serve as an early warning mechanism to flag potential misuse or abuse. The FDA confirmed that the removal of the blue dye is unlikely to have any impact on formulation quality and performance. As a result, the Company will not be required to repeat in vivo bioequivalence studies and pharmacokinetic studies submitted in the Oxycodone ER New Drug Application (“NDA”). The FDA also indicated that, from an abuse liability perspective, Category 1 studies will not have to be repeated on Oxycodone ER with the blue dye removed.
“Oxycodone ER was designed to have what we consider best in class abuse deterrence properties. As an additional feature, we introduced the innovative blue dye which is released when the product candidate is manipulated, to act as an early-warning system that may indicate when people need help,” said Dr. Isa Odidi, CEO of Intellipharmaceutics.“The work to show the potential social benefits of Oxycodone ER with blue dye may be lengthy. Since there is no impact on the abuse deterrent properties with the removal of the blue dye, we intend to conduct our previously announced Category 2 and 3 studies to support abuse-deterrent label claims using Oxycodone ER that does not contain the blue dye.”
The Company has already begun screening potential study participants for the previously announced Category 2 and 3 studies, which we intend to conduct over the coming months with an NDA resubmission targeted for later this year.
Dr. Isa Odidi concluded that, “We appreciate the additional direction given to us by the FDA, which allows us to further refine our path for Oxycodone ER. We believe its superior abuse-deterrent features are what really set our product candidate apart. Removing the blue dye at this time will facilitate making our important Oxycodone ER product candidate available to patients as quickly as possible.”
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.
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled- 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 Oxycodone ER abuse deterrent oxycodone formulation 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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Intellipharmaceutics International Inc.
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SOURCE: Intellipharmaceutics International Inc.