Just days after the Food and Drug Administration (FDA) proposed stricter rules for drugs containing hydrocodone – such as Lortab and Vicodin – to help curb the growing epidemic of prescription drug abuse, the agency announced that it has approved a purer form of hydrocodone that is even stronger than other drugs in its class.
The FDA approved Zohydro ER to treat pain severe enough to require around-the-clock, long-term treatment. The drug is approved for patients for whom alternative treatment has proved inadequate or ineffective.
The FDA did require the drug’s maker, Zogenix, to conduct post marketing studies for Zohydro ER to assess the known risks of misuse and abuse as well as any increased sensitivity to pain, susceptibility to addiction, and death with use for more than 12 weeks.
In 2011, more than 131 million prescriptions were written for hydrocodone-containing drugs, making it the most prescribed drug in the country. It is also consistently ranked along with oxycodone either first or second most abused drug in the nation.
The FDA announced last week that it plans to propose in December the reclassification of hydrocodone containing drugs to a Schedule II drug, the same category as the potent opioid Oxycontin. Schedule II drugs are limited by what types of medical professionals can prescribe them and how often they can be refilled.