Teva Pharmaceutical Industries Limited (NYSE:TEVA) received encouraging news with the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voting in favor (14 to 3) of an approval of Vantrela ER. Teva is looking to get Vantrela approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The advisory committees also backed Vantrela’s labeling as an abuse-deterrent product by the oral (14 to 3), nasal (14 to 3) and intravenous (16 to 1) routes of abuse, subject to approval.
Vantrela, which is an extended-release formulation of hydrocodone bitartrate, has been developed utilizing the company’s proprietary abuse deterrence technology. Teva expects that Vantrela’s label, upon approval, will carry a description regarding the product’s abuse-deterrent properties that are likely to reduce, but not fully prevent, abuse of the drug when the tablets are manipulated, based on the committees’ votes.
We note that the FDA generally takes the advisory committees' recommendation into consideration when reviewing candidates but is not bound by the same. With the panels in favor of approving Vantrela, we believe chances of gaining FDA approval are high.
We note that Pfizer, Inc. (NYSE:PFE) , which is also seeking FDA approval for its pain drug Troxyca ER (oxycodone and naltrexone), is expected to come up before the advisory committees today.
Teva is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Pfizer, Retrophin, Inc. RTRX and Bristol-Myers Squibb Company (NYSE:BMY) . All three stocks sport a Zacks Rank #1 (Strong Buy).
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TEVA PHARM ADR (TEVA): Free Stock Analysis Report
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