Federal regulators have approved a new pain killer that was designed to help chronic pain sufferers but thwart potential abuse.
On Wednesday, the Food and Drug Administration (FDA) announced that it has given the go signal for the drug called Targiniq ER as treatment for patients suffering from severe pain that require round the clock and daily opioid treatment for long term use, who do not receive adequate relief from other treatment options.
The drug, which was developed by Connecticut-based Purdue Pharma, is a combination of oxycodone, a powerful narcotic painkiller and naloxone, a drug used to reverse the effects of opioid overdose. In Targiniq, the naloxone blunts the euphoric effects of the oxycodone and is only activated when the drug is crushed, dissolved, injected or dissolved making it less enticing for abuse.
The FDA, however, admitted, that while the pill was designed to prevent abuse by drug addicts, it can still be abused when a person takes too many pills. The agency warned that taking too many Targiniq could cause potentially lethal overdose.
Sharon Hertz, from FDA's Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Addiction Products, said that developing opioids that are difficult to abuse is crucial in addressing the problem of people abusing prescription drugs.
The Centers for Disease Control and Prevention (CDC) estimates that the number of deaths associated with narcotic painkiller overdose has increased four times since 1990, causing over 17,000 deaths in 2011.
"Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse," Hertz said.
The FDA said that the drug, whose effectiveness and safety were assessed in a clinical trial involving 601 patients with chronic low back pain, is only prescribed for use by individuals suffering from chronic pain that do not respond well to other medications and is not recommended as as-needed painkiller.
Stephen Anderson, former president of the American College of Emergency Physicians' Washington chapter commended Purdue Pharma's effort to limit the likelihood of Targiniq from getting abused.
"Well done to the manufacturer for placing some built-in pharmacological protections," Anderson said. "It won't stop orally ingested overdose deaths, but will limit some of its 'street marketability.'"
The FDA still required Purdue Pharma to conduct postmarketing studies that would evaluate the serious risks associated with long term use of the drug including overdose, heightened sensitivity to pain or hyperalgesia, and death.