Late last week, Endo International plc (NASDAQ:ENDP) announced that the company has decided to withdraw its supplemental new drug application (sNDA) related to specific abuse deterrent labeling for Opana ER without prejudice to re-filing, following discussions with the FDA (Aug 11, 2016).
Endo had announced in Jun 2016 that it was informed that the FDA’s Advisory Committee will meet in the fall of 2016 to review the sNDA for Opana ER. Previously, the FDA was expected to render its decision on Opana ER by Jul 29, 2016. But the regulatory agency was expected to give its verdict following the Advisory Committee meeting.
However, the company plans to continue to collect and analyze epidemiological data related to Opana ER. The company expects generation of additional data and thereby will discuss with the FDA to determine the path forward for Opana ER.
We note that Opana ER is an opioid agonist approved for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate. The drug registered net sales of $83.2 million in the first half of 2016, down 7%. Sales continue to be impacted by generic versions of the non-crush resistant formulation of Opana ER.
Endo noted that its financial projections for 2016 did not assume approval of the sNDA.
Endo is a Zack Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Corcept Therapeutics Inc. (NASDAQ:CORT) , Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) and Eisai Co., Ltd. (OTC:ESALY) . All three stocks sport a Zacks Rank #1 (Strong Buy).
ENDO INTL PLC (ENDP): Free Stock Analysis Report
EISAI CO LTD (ESALY): Free Stock Analysis Report
PACIRA PHARMACT (PCRX): Free Stock Analysis Report
CORCEPT THERAPT (CORT): Free Stock Analysis Report
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