In a move designed to cut down on the risk of narcotic overdose and addiction, the FDA approved a new version of the powerful narcotic pain reliever oxycodone this month, which experts report is more difficult for patients to abuse.
The new prescription opioid, Targiniq ER, is a combination of oxycodone hydrochloride and naloxone hydrochloride. The oxycodone combination drug is formulated in an extended-release long acting (ER/LA) abuse-deterrent tablet. The FDA announced its approval in a press release on July 23.
Manufacturer Purdue Pharma formulated the pill to treat severe pain that requires daily, around the clock treatment, but in a formula which is difficult for patients to abuse.
The new drug was manufactured so that when it is crushed and snorted, or crushed and dissolved for injection, the naloxone is activated and blocks the euphoric effects of the oxycodone.
Naloxone is often used to reverse the side effects of opioid overdose, and becomes activated when the pill is crushed, snorted, dissolved or injected, making it more difficult for the drug to be abused.
The extended release narcotic painkiller is designed for patients whose alternative treatment options for pain management are ineffective or inadequate. It is not approved for as-needed pain relief and should only be prescribed to people for whom regular pain killers do not provide sufficient pain management.
Despite the abuse deterrent properties of the drug, critics remain concerned about its abuse potential. The FDA admits the drug can still be abused when taken orally by simply taking too many pills. Overdosing orally is the most common way hydrocodone is abused. An overdose of Targiniq in this manner can result in death.
“Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection,” according to the FDA.
Another reason critics are especially concerned about the new drug is because it has the same addictive and dangerous properties as pure oxycodone.
Targiniq ER is the second FDA approved ER/LA narcotic painkiller with approved labeling. The abuse deterrent properties meet the FDA’s 2013 draft guidance for industry.
The FDA is calling the approval of the new drug a “component of a broader approach” to reducing abuse and misuse of narcotic painkillers.
Targiniq ER was evaluated in a clinical trial of 600 patients who were treated for lower back pain with the medication. The study data highlighted the drug’s abuse deterrent features.
Despite the effectiveness of the drug as revealed in clinical trials, the FDA is requiring post marketing studies to assess the serious risks of the drug, abuse and misuse likelihood. They will evaluate any increased sensitivity to pain, addiction, overdose and even death, associated with long term use beyond 12 weeks.
Researchers found the most common side effects of the drug were nausea and vomiting.
“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 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.
Widespread Painkiller Abuse
Abuse of narcotic painkillers, such as Oxycodone, morphine and OxyContin, continues to rise as widespread abuse is seen across the country. Nearly 260 million prescriptions were written for opioid painkillers in 2012.
As such, the U.S. Centers for Disease Control and Prevention (CDC) indicated in 2012 that prescription drug overdoses reached epidemic proportions. The CDC report revealed a person dies of painkiller overdoses every 19 minutes.
Despite the continued abuse deterrent formulas and preventions, deaths involving an overdose of narcotic painkillers skyrocketed over the last 20 years. The rates of overdose quadrupled since 1990 and more than 17,000 people died from opioid overdose in 2011 alone.
Painkiller overdose death rates increased dramatically over recent years in Florida. After certain law enforcement measures were implemented and stricter prescribing guidelines were followed, Florida’s narcotic overdose death rate declined nearly 17 percent during 2010 to 2012.
Health experts remain optimistic after seeing the promising results in Florida, hoping if more abuse deterrent medications are introduced coupled with stricter prescribing and drug enforcement measures, the epidemic of overdose may decline across the country.