Endo International plc announced that it has been informed that the FDA’s Advisory Committee will meet in the fall of 2016 to review its supplemental new drug application (sNDA) for Opana ER.

 

Previously, the FDA was expected to render its decision on Opana ER by Jul 29, 2016. But now the regulatory agency will give its verdict following the Advisory Committee meeting. 

 

The sNDA for Opana ER included studies to evaluate the abuse deterrence of the formulation.

 

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 $175.8 million in 2015, down 11%. Sales continue to be impacted by generic versions of the non-crush resistant formulation of Opana ER.

 

In Feb 2016, Endo launched Belbuca in the U.S., which is also approved for the same indication. Although early healthcare provider feedback has been positive, the first few weeks of sales were slower than expected. Endo has a license and development agreement with BioDelivery Sciences International, Inc. for Belbuca.

 

Endo is a Zack Rank #4 (Sell) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP Quick QuoteANIP - Free Report) and Bristol-Myers Squibb Company (BMY Quick QuoteBMY - Free Report) . Both stocks sport a Zacks Rank #1 (Strong Buy).

 

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>