DUBLIN, Ireland — August 12, 2016 — 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).
About Endo International plc
Endo International plc is a global specialty pharmaceutical company focused on improving patients’ lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
SOURCE: Endo International
Published on Friday, 12 August 2016