Elite Pharmaceuticals Inc (ELTP)

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Wowsers something's up with FDA & opioids

Intellipharmaceutics International Inc. Announces Update on its Oxycodone ER New Drug Application

July 24, 2019

TORONTO, ON / ACCESSWIRE / July 24, 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 it has been advised by the U.S. Food and Drug Administration’s (“FDA”) that the FDA “is postponing product-specific advisory committee meetings for opioid analgesics,” including the one previously scheduled to discuss the Intellipharmaceutics New Drug Applications (“NDA”), “while it continues to consider a number of scientific and policy issues relating to this class of drugs.” According to the FDA, the reason for the postponement is not unique to our product and the Anesthetic and Analgesic Drug products Advisory Committee (“AADPAC”) meeting earlier planned by the FDA, to discuss our NDA will be rescheduled at a future date.

The FDA informed the Company that it would continue to review the Company’s NDA according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline, but noted that, due to the postponement of the AADPAC meeting, it is possible that the FDA may be unable to meet the PDUFA goal date of August 28, 2019.

Dr. Isa Odidi, CEO of Intellipharmaceutics, stated, “we are pleased that the FDA will continue to review our New Drug Application (“NDA”) according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline despite this new development.”

There can be no assurance that the meeting to discuss our NDA will be re-scheduled as planned or at all. 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 ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.