After two days of public hearings late last week addressing ways to make it more difficult to abuse opioids, no clear consensus on abuse-deterrent opioids emerged among FDA stakeholders. Researchers, regulators, industry, and patients agree that opioids are a magnet for drug abusers, but there is also widespread agreement that these drugs contribute to a major dollar market in the country: pain management. Only two drugs (the combination product oxycodone hydrochloride plus naloxone marketed as Targiniq and reformulated Oxycontin) have been granted abuse-deterrent labeling, but the FDA has made no secret of its desire to expand the number of these agents. Both the brand working group and the generic working group seemed to welcome the concept of a marketplace that accepted only the abuse-resistant formulations, but that “support” was couched in a number of cautions about possible exceptions, including addressing unmet needs or drugs that possess a unique benefit.
Read the full overview from MedPage Today here.