Endo Asked to Withdraw Pain Drug-Opana ER by FDA, Stock Down

Endo International plc ENDP received a huge setback when the FDA directed the company to voluntarily remove its opioid pain medication Opana ER (oxymorphone hydrochloride extended release) from the market over abuse concerns.  

In Mar 2017, the FDA Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees had voted in the ratio of 18 to 8 and consented that the benefits of reformulated Opana ER no longer outweigh its risks. The FDA asked the Advisory Committees to discuss the pre- and post-marketing data about the abuse of Opana ER, the product's overall risk-benefit profile, as well as the abuse of generic oxymorphone ER and oxymorphone immediate-release IR products.Few members stated that the benefits are now overshadowed by the continuing public health concerns around the product's misuse, abuse and diversion.

Notably, shares were down significantly following the news. The shares of Endo have underperformed the Zacks classified Medical-Drugs industry year to date. The  stock was down 16.4% against the industry's gain of 4.5%.

Opana ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Opana ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. The drug posted sales of $35.7 million in the first quarter of 2017, an increase of 20% year over year.

Endo, however, remains confident that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.  Despite the FDA's request to withdraw Opana ER from the market, the company feels that the request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Thus the company is evaluating the FDA's request and considering the appropriate steps to be taken.

Endo International PLC Price

 

Endo International PLC Price | Endo International PLC Quote

Zacks Rank and Stocks to Consider

Endo carries a Zacks Rank #3 (Hold). Some better ranked stocks in health care sector include VIVUS, Inc. VVUS, MEI Pharma, Inc. MEIP and Aeglea BioTherapeutics AGLE. While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Aeglea carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here.

VIVUS' loss per share estimates narrowed from 502 cents to 39 cents for 2017 over the ast 60 days. The company posted positive earnings surprises in all four trailing quarters, with an average beat of 233.69%. The share price of the company increased 2.7% year to date.

MEI Pharma's estimates moved up from loss per share of 1 cent to gain per share of the same for 2017, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with average beat of 66.56%. The share price of the company increased 27.8% year to date.

Aeglea's loss per share estimates narrowed from $3.64 to $2.48 for 2017 over last 60 days. The company posted positive earnings surprises in three of four trailing quarters, with average beat of 20.75%.

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