Washington, DC, United States (4E) – The Food and Drug Administration (FDA) approved Wednesday the prescription of the extended-release/long-acting painkiller Targiniq ER, which has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection.
The drug manufactured by Stamford-based Purdue Pharma L.P. becomes the second extended-release/long-acting (ER/LA) opioid analgesic approved by the agency after Zohydro ER, which was approved in October last year.
FDA said Targiniq ER treats pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It deters abuse because when crushed and snorted, or crushed, dissolved and injected, the naloxone in the drug blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose.
FDA, however, said Targiniq ER is not approved, and should not be used, for as-needed pain relief. It said Targiniq ER can still be abused, including when taken orally, which is currently the most common way oxycodone is abused. It warned that taking too much Targiniq ER for purposes of abuse or by accident can cause an overdose that can result in death.
“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.”
The FDA is requiring postmarketing studies of Targiniq ER, to assess the serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks. The FDA is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.
In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.
People taking opioids and anti-anxiety drugs should be monitored closely, according to Brady Grainer, COO of BioCorRx Inc. (OTC: BICX), which licenses Start Fresh Program (SFP), an addiction treatment that uses naltrexone implants and life coaching for patients.
“Any demographic of the population should be monitored closely if they are prescribed opioids or other addictive medicines for a prolong period of time. As it is commonly known, the longer someone takes an addictive substance the greater the chance they will become dependent on it.” Granier said in a statement last month.
The easy access to prescription drugs and opioids has resulted in at least 2.5 million Americans becoming dependent on them, according to the National Institute on Drug Abuse while a study of of federal data by USA Today found that use of some of the most commonly abused painkillers, such as hydrocodone and oxycodone, climbed more than 50 percent from 2007 to 2012.
Rehabilitation clinics offering SFP are dealing with such abuse in an innovative way. The two-part treatment use implants that releases Naltrexone.
Naltrexone was approved by the FDA in 1984 to treat opioid addiction and alcoholism in the mid-90′s. It has mainly been prescribed in oral or injection form until BioCOrRx developed SFP. The naltrexone implant lasts for months. It prevents relapse and helps with non-compliance of addicts, who typically don’t take medication as directed.
The second part of SFP is a life coaching that addresses the psycho-social aspects of the addiction. Once Naltrexone takes effect, patients are able to absorb the teachings of their coaches and counselors without the intrusive cravings distracting them from recovery. The one-on-one life coaching sessions can be done in Start Fresh clinics or through video conferencing for those living far from any of the centers. The entire program can last 6 to 8 months and can be done with complete privacy and with little or no time missed from work or family.
The SFP is already offered in California, Arizona, Nebraska, and Connecticut treatment centers.