FDA Approves New Painkiller From Oxy Maker Purdue Pharma | The Fix
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FDA Approves New Painkiller From Oxy Maker Purdue Pharma

A new oxycodone painkiller called Tarqiniq ER will feature a naloxone inhibitor when tablet is crushed.

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By John Lavitt

07/28/14

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Purdue Pharma, the infamous pharmaceutical company behind OxyContin, has just received approval for Targiniq ER, a new oxycodone-based narcotic painkiller. Called Targiniq ER, the pill is a combination of the narcotic oxycodone and naloxone, a drug that blocks the euphoric effects of oxycodone. Trying to change its tarnished image, the company is promoting the safety of the new formulation after pleading guilty in 2007 to misleading the public about the risk of Oxycontin addiction.

The Naloxone only takes effect, however, when the pill is crushed. The goal of the new drug is to prevent Targiniq ER from being crushed so it can be snorted or dissolved and injected. A problem with this approach is the majority of people who now abuse previously approved oxycodone derivatives do not abuse the painkillers in this fashion. They actually abuse prescription oxycodone derivatives like OxyContin, Percocet, and Percodan by simply taking too many pills.

After the disastrous approval of Zohydro and all the resulting bad press, the FDA is trying to change its own image. Nevertheless, the experts do not agree with this approach. Andrew Kolodny, chief medical officer of the Phoenix House, an alcohol and drug abuse treatment provider, told CNN, “When the pills are swallowed they are as addictive and dangerous as pure oxycodone."

Nevertheless, upon approving Targiniq ER, the FDA declared a victory. In an agency press release, Dr. Sharon Hertz, deputy director of the division of anesthesia, analgesia, and addiction products in the FDA's Center for Drug Evaluation and Research, declared, "Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse."

A problem with such early claims in regards to a new drug is Targiniq ER is an extended release formula. When addicts get their hands on such pills, they will pop them until they feel the high. This same problem happened with the extended release formula of OxyContin, resulting in thousands of overdoses from addicts taking too many pills. When the extended release formulas all hit at once, the extreme consequence was overdose and often death.

The FDA did warn that Targiniq could still be abused by taking too many pills. “Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection,” the press release said. They went on to illuminate future policy by stating, “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.”

As someone on the front lines of the prescription painkiller battle, Kolodny disagreed with this approach. “If we really want to turn this epidemic around, the most important thing is to stop creating new cases of addiction," Kolodny said. "Coming up with new gimmicks isn’t going to help."

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