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FDA approves pain drug that has reduced risk of abuse

Purdue’s Targiniq ER developed to deter snorting and injection

purdue pharma logoThe US FDA has approved a new opioid-based pain treatment that is intended to reduce the risk of abuse by people who use the drug for non-medical reasons.

Targiniq ER, a combination of oxycodone hydrochloride and naloxone hydrochloride, is now available in the US to treat pain deemed severe enough to require around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The drug is an opioid analgesic, a form of pain treatment that is prone to abuse - often by people who manipulate the formulation so it can be taken via injection or by snorting.

Purdue Pharma, the company behind Targiniq ER, has developed the drug to deter, but not totally prevent, such abuse under new guidance published by the FDA covering abuse-deterrent opioids.

The pain relieving effects in Targiniq ER come from oxycodone – the active ingredient in Purdue's existing OxyContin - although the new product also contain naloxone, which reverses the effects of opioid overdose.

Targiniq ER is still effective as pain relief when taken orally, but when the drug is crushed or dissolved to be snorted or injected, the naloxone in the product blocks the euphoric effects of oxycodone. According to the FDA, this means the drug is “less liked by abusers than oxycodone alone”.

Dr Sharon Hertz, deputy director of the Division of Anesthesia, Analgesia and Addiction Products at the FDA, described the abuse of prescription drugs as a “public health crisis” in the US.

“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,” she said.

The availability of the abuse-deterrent version of oxycodone has led to the FDA banning generic versions of OxyContin due to the risk of misuse.

Article by
Thomas Meek

25th July 2014

From: Sales, Regulatory

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