FDA approves oxycodone painkiller designed to prevent drug abuse
The U.S. Food and Drug Administration says it has granted approval of a new formulation of a powerful but controversial pain relief drug intended to make it hard to abuse.
Targiniq ER from Purdue Pharma is formulated as a combination of a long-acting type of the opoid oxycodone with a medication known as naloxone, commonly utilized to reverse effects of opoid overdoses, regulator say.
However, in Targiniq the included naloxone is intended to block euphoric effects of oxycodone and make it less attractive to addicts and thus deter abuse, they say.
"Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection," the FDA said in a statement. "When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone."
It becomes active only when the pills have been crushed, and doesn't activate when the intact pills are swallowed in the prescribed manner.
Crushing and then snorting or injecting the drug was the abuse pattern leading to addictions and overdoses in Purdue's original OxyContin formulation.
People can still abuse the new formulation by swallowing a number of pills whole, but in that case the medication is released slowly rather than all at once, again making it less attractive for addicts, the FDA noted.
"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 Sharon Hertz of the FDA's Center for Drug Evaluation and Research.
Not all experts consider the new drug a solution to abuse issues, and express concern it may even make the problem worse.
In believing Targiniq to be safe, doctors may turn to prescribing it instead of looking for treatment alternatives, says Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, which could "exacerbate the crisis".
"If we really want to turn this epidemic around, the most important thing is to stop creating new cases of addiction," he says. "Coming up with new gimmicks isn't going to help."
Opiate overdoses have more than quadrupled from a decade ago, causing around 17,000 deaths each year, the Centers for Disease Control and Prevention has said in declaring the steep increase an epidemic.