Actavis gets go-ahead to expand generic painkiller portfolio
An expanded roster of generic Opana ER is set to hit the market. The FDA approved Actavis' application to manufacture 5mg, 10mg, 20mg, 30mg and 40mg doses of the oxymorphone hydrochloride extended-release tablets on Friday. Actavis already had the agency's OK to make 7.5mg and 15mg versions of the prescription painkiller.
Although Leerink Swann analyst Michael Schmidt wrote in a research note that the approval was not unexpected, the approval comes at a thorny moment in the opioid space. The industry has been under pressure to manufacture painkillers that are harder to abuse, but the rules surrounding what constitutes "abuse-resistant" is a relative measure.
For example, Endo, the original Opana ER manufacturer, lost its fight against generic versions of its drug because its later formulation—also called Opana ER—was too easily manipulated, whereas Purdue Pharma knocked out a potential generic competitor, because the regulator found that the recent OxyContin iteration was harder to abuse than its predecessor.
At the same time, worries about abuse continue to mount. The Centers for Disease Control published an abuse report earlier this month that found women were increasingly abusing prescription painkillers. The CDC said that although painkiller deaths are rising among men and women, the spike is steeper among women, quadrupling between 1999 and 2010, compared to increasing by more than two-and-a-half times among men during that same period.
The CDC's July report found that women between the ages of 45 and 54 were the most at-risk for prescription painkiller deaths, while women between 25 and 54 were more likely than those in other age groups to end up in the ER over painkiller abuse or misuse.
Health and Human Services' Office of Inspector General also released a report in June that addressed addictive medication prescription rates among Medicare Part D members. These drugs are on the DEA's list of controlled substances that appear on Schedule II and Schedule III. The report found high prescription rates among these drugs and prescribing patterns that “warrant further scrutiny.”
The OIG previously found that Medicare covered $25 million for Schedule II drug refills, which indicate a two-fold problem in that there are high prescribing rates and that “Federal law prohibits the refilling of Schedule II controlled substances without a new prescription."
Schedule II drugs include agents like methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), and oxycodone (OxyContin), while Schedule III includes compounds such as Vicodin, certain codeine formulations and ketamine.
The CDC estimates that around 7 million people died of prescription drug abuse or misuse in 2010.