FDA approves hard-to-abuse opioid pain drug

July 31, 2014

FDA approved oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER, 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.

FDA approved oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER, 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analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.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, 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.

“The approval of Targiniq ER serves as a method for deterring drug abuse through the addition of naloxone,” said FormularyWatch advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala. “This combination has been done with other agents and may potentially reduce the incidence of abuse or overdoses with OxyContin.” 

Targiniq ER is not approved, and should not be used, for as-needed pain relief. Given Targiniq ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.

A clinical trial of 601 people with chronic low back pain evaluated the safety and effectiveness of Targiniq ER. The safety database supporting approval included treatment of more than 3,000 people with Targiniq ER. Data from in vitro and in vivo abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse such as snorting and injecting. Nausea and vomiting were the most common side effects.

FDA is requiring postmarketing studies of Targiniq ER, to assess the serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose, and death associated with long-term use beyond 12 weeks. The agency is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.

Additionally, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS).