Targiniq ER oxycodone/naloxone regulatory update

FDA approved an NDA for Targiniq ER oxycodone/naloxone from Purdue 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 an abuse-deterrent, extended-release/long-acting combination of oxycodone and naloxone. Purdue declined to disclose launch plans, including pricing.

FDA is requiring postmarketing studies for Targiniq ER to assess the risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use, as well as studies to further assess the effects of the drug’s abuse-deterrent features. FDA said Targiniq ER is the second ER/LA opioid analgesic with abuse-deterrent labeling consistent with draft guidance the agency issued last year. The product is already marketed by Purdue in Canada and by affiliate company Mundipharma in Europe and Australia. Shionogi has exclusive, Japanese rights to the drug from Mundipharma under a 2013 deal. ...