FDA approves Targiniq ER an opioid analgesic for treatment of Severe Pain - Purdue Pharma

The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) from Purdue Pharma, an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labelling describing the product�s abuse-deterrent properties consistent with the FDA�s 2013 draft guidance for industry, Abuse-Deterrent Opioids � Evaluation and Labeling.

Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER 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. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death.