Pharmaceutical

Attorneys general ask FDA to rethink its approval of first single-ingredient hydrocodone painkiller

hydrocodone 435x303 Attorneys general ask FDA to rethink its approval of first single ingredient hydrocodone painkiller Twenty-eight attorneys general are calling for the removal of powerful new painkiller Zohydro, arguing that the narcotic would only add to the national epidemic of prescription drug abuse.

Zohydro, the first and only single-ingredient hydrocodone painkiller approved by the Food and Drug Administration (FDA), was granted clearance by the agency in October. It is an extended release formulation that is considered five to 10 times more potent than hydrocodone combination pill such as Vicodin. The state prosecutors are asking the FDA to either revoke the drug’s approval or require the drug maker Zogenix to change the formulation so that it is harder to abuse.

Hydrocodone has previously been available in combination with non-addictive painkillers such as acetaminophen, such as Vicodin. It was thought that in combination with other drug ingredients, hydrocodone was harder to abuse. However, this theory has been disputed in recent years. Hydrocodone is in a class of painkillers known as opioids, which also includes the drugs morphine, oxycodone, codeine and methadone.

Hydrocodone is one of the most prescribed drugs in the country with more than 131 prescriptions written in 2011 alone. It is also one of the most abused prescription drugs on the market.

The FDA’s approval of Zohydro shocked many medical professionals, since an agency advisory panel had previously voted not to recommend its approval because of its potential for abuse. The agency has also in recent years taken a harder stand against drug companies, requiring medications with addictive qualities to be formulated in a way that makes them more difficult to be tampered with and abused.

However, Zohydro was approved based on the rationale that these formulations help protect patients against liver damage, as is the risk with drugs that contain acetaminophen. Three other drug companies are also developing extended-release versions of single-ingredient hydrocodone drugs. Zogenix’s drug is expected to hit the market in early 2014.

Source: PharmPro