On Wednesday the Food and Drug Administration announced their approval of Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-relief tablets) - an opioid analgesic that possesses abuse-deterrent properties.
According to the National Institute on Drug Abuse, an estimated 12-21 million people worldwide abuse opioids, and over 1.9 million people in the United States were addicted to prescription painkillers as of 2010. The number of unintentional overdose deaths from prescription opioid pain relievers has quadrupled in the US since 1999, with the South and Northeast regions suffering the highest numbers in these categories.
As a result of these alarming statistics, the Food and Drug Administration is working to provide stricter oversight of prescription refills, and just yesterday approved a new opioid that is said to discourage abuse among those who are prescribed the drug. This comes only five months after Zohydro, an extended-release painkiller that is available in doses that are five times the amount found in similar immediate-release hydrocodone pills, hit the market in the United States.
"The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.," said FDA's Dr. Sharon Hertz, deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's Center for Drug Evaluation and Research, in this ABC News article.
In trials, the safety of the newly approved Targiniq ER opioid analgesic was tested on 601 patients who suffered from chronic back pain. The oxycodone is combined with the heroin/opioid overdose reversal drug, naloxone, which is expected to make abuse and misuse less enticing to many addicts. However, the naloxone doesn't kick in when the pills are swallowed; only if they are crushed and snorted or injected. The pill can still be abused if taken in excess orally, but the main issue with addiction consists of the drug users who crush up the pills and consume them in other ways.
The FDA will continue to work on studies of the new opioid, as they've required the drug's manufacturer, Purdue Pharma L.P., to conduct long-term follow-up studies beyond 12 weeks that will track rates of abuse, addiction, overdose, and death associated with Targiniq. Over 3,000 people have already been approved to be treated with the drug.
You can read more about the FDA's approval of Targiniq in this Los Angeles Times article.
