Pfizer announced that the Food and Drug Administration (FDA) has approved Troxyca ER (oxycodone HCl and naltrexone HCl) extended-release capsules 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.
Troxyca ER is a CII controlled substance that contains pellets of oxycodone HCl, an opioid agonist, which surround sequestered naltrexone HCl, an opioid antagonist. Naltrexone is intended to remain sequestered and oxycodone is delivered to patients in an extended-release manner. When the pellets are crushed, the sequestered naltrexone is released and acts to counteract the effects of oxycodone. Its abuse-deterrent properties were demonstrated in a series of in vitro laboratory studies and 3 clinical abuse-potential studies that used crushed Troxyca ER by oral and intranasal routes of administration and the intravenous (IV) route. Troxyca ER capsules contain properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes, however, abuse by these routes is still possible.
Troxyca ER will be available as 10mg/1.2mg, 20mg/2.4mg, 30mg/3.6mg, 40mg/4.8mg, 60mg/7.2mg and 80mg/9.6mg strength capsules in 100-count bottles.
For more information call (800) 438-1985 or visit PfizerPro.com.