Purdue Pharma's Targiniq ER combines a long-acting form of the opioid analgesic oxycodone with the medication naloxone, which is commonly used to reverse the effects of an opioid overdose.
In Targiniq, the naloxone is included not to reverse an overdose but to block the euphoric effects of oxycodone and thus make it less enticing to many addicts.
The new drug, approved Wednesday, can be crushed and then snorted or injected to release its full narcotic payload instantly — the pattern of abuse that fueled addiction and overdoses involving Purdue's original OxyContin pills. The naxolone becomes active when the pills are crushed.
However, the naxolone doesn't kick in when the pills are swallowed whole. Most people who abuse oxycodone take the pills this way, according to the FDA.
Targiniq was expected to "deter, but not totally prevent," abuse, the FDA said in its statement announcing the drug's approval.
Sharon Hertz, deputy director of the FDA's Division of Anesthesia, Analgesia and Addiction Products, said the move was part of an agency strategy to meet the needs of pain sufferers while deterring addiction and overdose.
"The FDA is committed to combating the misuse and abuse of all opioids," Hertz said in a statement. "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."
But Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said the FDA's approval of Targiniq could "exacerbate this crisis."
If doctors believe Targiniq is safe, they may be more inclined to prescribe it instead of seeking alternatives, said Kolodny, chief medical officer for the Phoenix House Foundation, a nationwide network of addiction treatment centers.
"If we really want to turn this epidemic around, the most important thing is to stop creating new cases of addiction," he said. "Coming up with new gimmicks isn't going to help."
A spokesman for Purdue declined to comment on Kolodny's concerns. In a statement, Chief Executive Mark Timney lauded the company's efforts to develop drugs that provide pain relief and help "deter misuse and abuse."
Prescription pain relievers such as OxyContin are involved in more than 16,000 fatal overdoses annually, and the U.S. Centers for Disease Control and Prevention declared the steep rise in such deaths over the last decade an epidemic.
OxyContin releases up to 80 milligrams of oxycodone over 12 hours. As with other forms of oxycodone, taking too much Targiniq via any method can cause an overdose and death.
The original OxyContin pills were introduced in 1996, but Purdue stopped selling them in 2010 and introduced a new formulation that was more difficult to crush. Until Wednesday, it was the only abuse-deterrent narcotic pain reliever approved by the FDA.
Lynn Webster, a pain and addiction specialist and former president of the American Academy of Pain Medicine, agreed that abuse-deterrent drugs were no substitute for judicious prescribing.
But, he said, "the obvious alternative is not to have abuse-deterrent formulations, and I don't know anyone who would find that preferable."
The approval of Targiniq was the second controversial decision by the FDA in recent months. In April, the agency touched off a firestorm of criticism when it gave a San Diego company permission to sell Zohydro, a long-acting, crushable form of hydrocodone, another widely abused narcotic.
Targiniq was approved to provide relief for pain severe enough to require daily, around-the-clock, long-term opioid treatment when no alternatives are available. The FDA cautioned that it should not be used for as-needed pain relief.
"Given Targiniq ER's risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management," the agency said.