Extended-Release Opioid Receives FDA Approval, But In The End People Who Abuse Painkillers Will Find A Way
Prescription drug abuse has reached staggering numbers over the past two decades, and at the heart of this epidemic reaching every part of the United States lies oxycodone and other drugs in the opioid analgesic class. On Wednesday, the Food and Drug Administration (FDA) announced its approval of Targiniq ER, an extended-release opioid combining the effects of oxycodone and a drug commonly used to reverse the effects of opioid overdose, known as naloxone. Despite this apparent solution, will a new drug do anything to deter drug abusers from getting their fix?
"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.,” Dr. Sharon Hertz, deputy director of the Division of Anesthesia, Analgesia, and Addiction Products at the FDA, said in a statement. “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.”
People who use opioids such as oxycodone tend to crush up the pill and snort it, or dissolve it and inject it to get a quicker and more potent euphoric feeling. In hopes of deterring drug abusers, Purdue Pharma L.P., which originally marketed a harder to crush version of their opioid OxyContin in 2010, created Targiniq ER. When Targiniq ER is crushed and snorted, or dissolved and injected, the typical euphoric effects of oxycodone are blocked by naloxone. Oxycodone and similar opioid analgesics, including morphine and hydrocodone, offer their pain-relieving effect by binding to brain receptors that dull painful sensation. With Targiniq ER, naloxone takes the place of oxycodone on the brain receptors.
Purdue Pharma conducted clinical trials on 601 people with chronic lower back pain to examine the safety and effectiveness of Targiniq ER. The drug’s approval was also supported by a safety database that recorded the treatment of over 3,000 people. Targiniq ER’s ability to deter drug abusive tendencies such as snorting or injecting the drug was confirmed by testing in the laboratory and on people. To assess serious risks posed by Targiniq ER, including misuse, abuse, increased pain sensitivity, addiction, overdoes, and death associated with prolonged use after 12 weeks, the FDA has required postmarketing studies. The FDA admitted that Targiniq ER’s properties will only be able to deter drug abuse by snorting or injecting, but it will not be able to completely prevent it.
According to the Centers for Disease Control and Prevention, 100 people each day in the United States suffer a drug overdose, and most of them are caused by prescription drugs. Over two million people reported using prescription painkillers nonmedically for the first time within the last year in 2010. Fifty-five percent of people who abuse prescription painkillers obtain their drug of choice for free from a friend or relative, 17.3 percent are prescribed them by a single doctor, 11.4 percent buy them from a friend or relative, 4.8 percent take them from a friend or relative without permission, and 4.4 percent get them from a drug dealer.
One aspect of Targiniq ER’s approval to consider is how many drug abusers who are unable to achieve the euphoric feeling they look for in prescription pills will turn to the more dangerous alternative of heroin. The majority of people who start off abusing prescription painkillers eventually make the switch to heroin, which is cheaper and can provide the same euphoric rush as opioid analgesics. While prescription painkillers carry a street value of between $20 and $60, a bag of heroin can cost between $3 and $15. Some opioid abusers turn to heroin simply because they are not getting the rush they desire from prescription pills, so we have to wonder if Targiniq ER will only hasten this change.