FDA Approves Purdue Pharma L.P.’s Hard-to-Abuse Narcotic Painkiller

FDA Approves Purdue Pharma’s Hard-to-Abuse Narcotic Painkiller
July 28, 2014
By Renee Morad, BioSpace.com Breaking News Staff

The Food and Drug Administration approved a drug combining oxycodone and naloxone that is designed to discourage abuse by those addicted to painkillers.

The new drug Targiniq ER, developed by Stamford, Connecticut-based Purdue Pharma, is an extended release tablet intended to treat pain severe enough to require daily, around-the-clock treatment for which alternative treatment options are inadequate.

Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting or injection, according to the FDA. When crushed and snorted, or crushed, dissolved and injected, the naloxone in the drug blocks the euphoric effects of oxycodone.

The national epidemic of prescription opioid abuse has been on the rise. Deaths linked to addictive medications like OxyContin and Vicodin have quadrupled since 1990 to an estimated 16,500 in 2010, which is the most recent year for which the Centers for Disease Control and Prevention reports figures.

"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, M.D., deputy director of the division of anesthesia, analgesia and addiction products 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,” Hertz said.

Purdue Pharma has been under fire in the past for not being forthright about the addictive power of OxyContin. In 2007, Purdue Pharma and three of its executives paid $634 million and pleaded guilty to charges of misleading the public about OxyContin’s safety and addictiveness.

The company has since introduced a harder-to-abuse version of OxyContin that is designed to resist crushing, chewing and dissolving.

The FDA said Targiniq ER is not approved for as-needed pain relief and 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 safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain. The safety database supporting approval included treatment of more than 3,000 people with Targiniq ER. Data from in vitro, or in a laboratory, and in vivo, or testing with people, abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse, such as snorting and injecting.

The most common known side effects of Targiniq ER are nausea and vomiting, according to the FDA.

Read more recent drug approval news here.

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