Prescription pain medication is one of the most widely abused substances in America, third behind alcohol and marijuana. About 4.8 million Americans have abused pain medication in the past month, according to the latest data from the Substance Abuse and Mental Health Services Administration (SAMHSA). This abuse is the leading cause of death and emergency department visits due to drugs. The number of overdoses due to opioid painkillers is higher than that of heroin and cocaine combined, and the deaths caused by prescription medication is now the leading cause of accidental death in America.
This abuse puts doctors and pharmacists in a precarious position. There are many people with chronic pain who need a strong pain relief, such as that offered by opioid pain medication. However, with a high risk of abuse, it can be difficult to provide them with enough pain medication while also preventing a patient from forming an addiction or abusing the substance. The US Food and Drug Administration (FDA) recently approved a new drug that hopefully will help: Targiniq ER.
What is Targiniqu ER?
Targiniq ER is a new medication by Purdue Pharma LP that offers extended release tablets comprised of a combination of oxycodone hydrochloride and naloxone hydrochloride. The formula provides an extended release and long acting opioid analgesic, which will provide pain relief for those who need daily, around-the-clock pain management for which other treatments have failed.
What about Abuse Risks?
One problem the pharmaceutical industry has had to face when developing strong, long-lasting opioid pain mediation is how to deter the abuse of the substance. The dosage in extended release tablets, such as Targiniq ER, is typically higher, because the pill is made to provide small doses throughout the day. The idea is to reduce how many pills a person has to take within one day. However, if there are not enough preventative measures in place, then people can simply crush the pill to get the full dosage in one go.
Targiniq ER has followed the FDA's guidelines for abuse-deterrent guidelines. One of the main ways it deters abuse is by including naloxone hydrochloride. The naloxone in the medication blocks the euphoric aspects of oxycodone, even if it is crushed. Naloxone is the common drug used to counter the effects of opioid overdose, and is typically used in emergency situations. Recently, an auto-injecting version of naloxone hydrochloride, Evzio, was approved by the FDA as an emergency device that can be used by non-medial professionals.
The inclusion of naloxone reduces the potential for abuse more than medication that only contains oxycodone. However, the marketers do warn that Tagline ER still has a risk to be abused, especially when taken orally, including taking an overdose that could result in death.
Who Should Take Targiniq ER?
Targiniq ER is made for those who have intense chronic pain for which other forms of treatment have not been successful. It is not for as needed treatment for pain relief. The most common side effects of the drug include nausea and vomiting.
As part of the approval, the FDA has required that there will be postmarketing studies of the drug that will continue to assess the risks for misuse, abuse and addiction, as well as increased sensitivity to pain or overdose associated with using the drug beyond 12 weeks. They also are requiring postmarketing studies to continue to see how well the abuse-deterrent features work. The drug will also be part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which is a program in place that requires companies to provide health care professionals education on how to safely prescribe the medication, as well as medication guides and patient counseling documents.