Pharmaceutical company Zogenix is hoping to get a tamper-resistant formulation of its powerful opioid Zohydro reviewed by drug regulators this fall and, if approved, begin marketing it by early next year.
Zohydro is a pure hydrocodone painkiller which was approved by the Food and Drug Administration (FDA) last fall and hit the market earlier this year amid much controversy. Medical groups and anti-abuse organizations teamed up to petition the FDA to reconsider its approval of Zohydro, and several attorneys general joined the fight arguing that allowing another powerful painkiller on the market would only exacerbate the prescription drug abuse epidemic in the country. Opioids are by far the most abused prescription drug in the United States.
The FDA stood by its decision to approve Zohydro, the only single-ingredient hydrocodone on the market, saying people living in chronic pain need more treatment options. Zohydro contains the active ingredient hydrocodone without other painkillers.
For example, Vicodin contains hydrocodone and acetaminophen. The FDA pointed to acetaminophen toxicity which can cause liver damage. Zohydro, however, has five times the hydrocodone as Vicodin.
Critics argued that the FDA should have held its approval until a tamper-proof formulation of pure hydrocodone could be manufactured, making it more difficult to be abused.
Opioids, in particular extended-release versions, when abused are often crushed and injected or snorted to deliver a more intense high. Abuse-resistant formulations would allow the drug to maintain the medicine’s extended release properties when crushed or chewed.
Zohydro says it plans to submit an extended release capsule version of Zohydro early next year and a tablet form of the drug in early 2016.