The Food and Drug Administration has approved a new extended release version of oxycodone with an abuse deterrent formula. The drug, which will be marketed by Purdue Pharma under the brand name Targiniq ER, is only the second opioid painkiller with FDA approved labeling that describes its abuse deterrent properties.
Targiniq combines oxycodone with naloxone, a drug that is used to reverse the effects of opioid overdose. Although designed to discourage abuse, the FDA says Targiniq can still be abused and should only be prescribed to patients who can’t get adequate pain relief from other medications.
“Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. 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,” the FDA said in a statement.
The safety and effectiveness of Targiniq was evaluated in a clinical trial of over 600 people with chronic low back pain. The drug’s abuse deterrent features were tested in further studies on over 3,000 people. The most common side effects of Targiniq were nausea and vomiting.
The FDA is also requiring postmarketing studies of Targiniq to assess the risk of misuse, addiction, overdose, and death associated after long term use of over 12 weeks.
“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, MD, a deputy director in the FDA’s Center for Drug Evaluation and Research.
“Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”
The FDA is under intense public and political pressure to fight the so-called epidemic of prescription opioid abuse. Over 16,500 deaths in the U.S. were linked to opioids in 2010, although recent research has questioned the validity of that estimate. According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.
“We are pleased that the FDA has approved another analgesic treatment option for people with chronic pain. This is the second product in Purdue’s pain management portfolio to receive labeling from the FDA describing the product’s abuse-deterrent characteristics,” said Mark Timney, Purdue Pharma’s President and CEO.
“When prescription pain medications with abuse‐deterrent properties are accessible and used appropriately, then patients, clinicians, payers, and society can all benefit.”
Earlier this month, the FDA gave a priority review designation to Purdue’s “pure” hydrocodone painkiller, which is also made with an abuse deterrent formula. The FDA gives priority review to new drugs if they offer “significant improvements” in safety and effectiveness compared to existing medications. Purdue expects the FDA to make a decision in October.
That is the same month San Diego based Zogenix (NASDAQ: ZGNX) plans to file a new drug application for an abuse deterrent formulation of Zohydro, the controversial hydrocodone painkiller the company introduced without any tamper resistant properties.
In addition to Purdue and Zogenix, Pfizer (NYSE: PFE) and Teva Pharmaceuticals (NYSE: TEVA) are also developing hydrocodone painkillers with abuse deterrent properties.
Oxycodone is the active ingredient in OxyContin, which many addiction experts say helped fuel the rise of prescription opioid abuse when it was introduced by Purdue in 1996.
In 2007, several Purdue executives pleaded guilty to a felony count of misbranding OxyContin, by playing down its addictive side effects. The company and its executives were fined $634 million.