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Pfizer Inc. (PFE) - free report >>
Geron Corporation (GERN) - free report >>
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Pfizer's (PFE) Pain Drug Troxyca ER Receives FDA Approval
Pfizer Inc. (PFE - Free Report) announced that the FDA has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options are inadequate.
The FDA approval was expected as the Anesthetic and Analgesic Drug Products Advisory Committee, and Drug Safety and Risk Management Advisory Committee had voted (9 to 6) in favor of an approval of Troxyca ER this June.
Per Pfizer’s press release, although it’s not impossible, Troxyca ER has properties to reduce abuse when crushed and administered by oral and intranasal routes. Nevertheless, it is the only oxycodone with oral abuse-deterrent features, as described in the labeling.
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We note that Teva Pharmaceutical Industries Limited (TEVA - Free Report) , which is seeking FDA approval for its own pain drug Vantrela ER, had received a favorable voting from the agency’s advisory committees (14 to 3) for an approval of Vantrela ER.
Teva, too, is looking to get Vantrela ER approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options are inadequate. The advisory committees had also backed Vantrela ER’s labeling as an abuse-deterrent product through the oral, nasal and intravenous routes, subject to approval.
Pfizer is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Geron Corp. (GERN - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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