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Endo Pharmaceuticals, Inc.

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Endo Announces OPANA® ER Regulatory Update
DUBLIN, Aug. 12, 2016 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that based on an August 11, 2016 discussion with the U.S. Food and Drug Administration (FDA), the Company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for OPANA® ER without prejudice to re-filing. The Company plans to continue collecting and analyzing epidemiological data relating to OPANA® ER. Endo's financial projections for 2016 did not assume approval of the sNDA.
"We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance OPANA® ER," said Sue Hall, Ph.D., Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo. "We believe in the ability of OPANA® ER to continue making a difference in the lives of appropriate patients and remain committed to safely and effectively addressing the needs of the pain patient community."
OPANA® ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate. The sNDA for OPANA® ER, which is formulated using INTAC® Technology, included studies designed to evaluate the abuse deterrence of the formulation. INTAC® Technology increases tablet hardness using a high molecular weight polymer (polyethylene oxide).
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Source: press release, 8/12/16. http://www.endo.com/news-events/press-releases

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Endo Announces FDA Advisory Committee Meeting For OPANA® ER
DUBLIN, June 15, 2016 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), today announced that, based on discussions with the U.S. Food and Drug Administration (FDA), the Company has been notified that an Advisory Committee of the FDA will be convened in the fall of 2016 to review the Company's Supplemental New Drug Application (sNDA) for OPANA® ER. As a result of the Advisory Committee meeting, the current Prescription Drug User Fee Act (PDUFA) date of July 29, 2016 for the OPANA® ER sNDA will not be met and the action on the supplement is expected to be taken by the FDA as soon as possible following the Advisory Committee meeting.
"Endo believes in the ability of OPANA® ER to continue making a difference in the lives of appropriate patients," said Sue Hall, Ph.D., Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo. "Endo has been a long standing leader in treating pain and we are working to advance new options to safely and effectively address the unique needs of the pain patient community."
OPANA® ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate. The sNDA for OPANA® ER, which is formulated using INTAC® Technology, includes studies designed to evaluate the abuse deterrence of the formulation. INTAC® Technology increases tablet hardness using a high molecular weight polymer (polyethylene oxide).
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Source: press release, 6/15/16. http://www.endo.com/news-events/press-releases

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Opana ERAnesthesiologyPain managementOpioid analgesicµ-opiod receptor

Mechanism of action: Opana ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Oxymorphone is a semisynthetic derivative of morphine that interacts predominantly with the opioid mu-receptor.

Phase of Development: Filed

Event Type: Regulatory FDA: Advisory Committee Meeting

Dates: 2016-09-01 - 2016-10-31

Results: Discontinued