FDA gives the nod to Purdue Pharma's Targiniq ER.
FDA has approved a new oxycodone painkiller that’s designed to be more difficult for drug abusers to exploit.
Targiniq ER (Purdue Pharma) is an extended-release tablet that combines oxycodone, the active ingredient in OxyContin, with the drug naloxone. The latter is used to reverse the overdose effects of opioids.
Targiniq ER was approved for daily, round-the-clock, long-term pain treatment that does not respond to other medications. It is also said to be more difficult, but not impossible, to abuse. It should not be used for as-needed pain relief, FDA stated.
Public health crisis
"The FDA is committed to combating 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 [United States]," said Sharon Hertz, deputy director of the FDA Division of Anesthesia, Analgesia and Addiction Products.
According to FDA, if the Targiniq ER pills are crushed and then snorted or injected, the naloxone will block the euphoric effects of the oxycodone. However, FDA officials concede that abusers can simply swallow the tablets instead of crushing them.
Overdose deaths linked to painkillers such as OxyContin and Vicodin (16,500 in 2010) have quadrupled since 1990, according to the Centers for Disease Control and Prevention.
Worse, not better
Some critics believe FDA’s approval of Targiniq ER will make the country’s drug abuse problem worse.
“If we really want to turn this epidemic around, the most important thing is to stop creating new cases of addiction,” Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, told the Los Angeles Times. “Coming up with new gimmicks isn’t going to help.”
FDA officials said Purdue will be required to conduct long-term follow-up studies tracking rates of abuse, addiction, overdose, and deaths linked to Targiniq ER. In addition, the drug is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy, requiring educational programs for healthcare providers about safe prescribing of these analgesics and Medication Guides and patient counseling for safe use, storage, and disposal of the drugs.
Safety and efficacy
Its safety and efficacy were analyzed in a clinical trial of more than 600 patients with chronic low-back pain. Its safety was supported by additional data from more than 3,000 individuals treated with Targiniq ER. The drug was also tested in vitro and in vivo with patients to observe its effectiveness in deterring abuse by individuals seeking to snort or inject it.
In the study of Targiniq ER, the most common side effects associated with the opioid analgesic were nausea and vomiting.