Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista(TM) NDA
FDA Response Provides Path toward Commercialization of Rexista™
TORONTO, Sept. 25, 2017 (GLOBE NEWSWIRE) -- 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- and targeted-release oral solid dosage drugs, today provided an update on its RexistaTM, henceforth referred to as Oxycodone Hydrochloride Extended-Release Tablets ("Oxycodone ER"), program.
The Company has received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") for its Oxycodone ER New Drug Application ("NDA"). In its CRL, the FDA provided certain recommendations and requests for information, including that Intellipharmaceutics complete the relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration. The FDA also requested additional information related to the inclusion of the blue dye in the Oxycodone ER formulation, which is intended to deter abuse. The FDA has determined that it cannot approve the application in its present form.
"We are very encouraged by the FDA's response as it clarifies our path forward for Oxycodone ER," said, Dr. Isa Odidi, CEO of Intellipharmaceutics. "We had already planned the additional Category 2 and Category 3 studies the FDA has requested and we do not expect they will impact our anticipated commercialization timeline for Oxycodone ER."
Intellipharmaceutics has been given one year to respond to the CRL, and can request additional time if necessary. The FDA has also requested that Intellipharmaceutics submit an alternate proposed proprietary name for Oxycodone ER.
Dr. Odidi concluded, "We will continue to work closely with the FDA to provide them with the additional information they requested, including data supporting the label claims related to Oxycodone ER's abuse-deterrent properties. We believe our Oxycodone ER product can play an important preventative role in the midst of a serious opioid abuse crisis particularly impacting North America. The Company will be providing regular updates as we execute on our Oxycodone ER NDA resubmission plan."
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.
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