US regulators have issued a green light for Purdue Pharma’s long-term opioid analgesic with abuse-deterrent properties.
The US Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate) for use in patients who need daily, 24-hour, long-term opioid treatment and for which alternative treatment options are inadequate.
The drug is the first and only hydrocodone product to be recognised by the FDA as having abuse-deterrent properties, expected to deter misuse and abuse via chewing, snorting and injection, though abuse by the intravenous, intranasal, and oral routes is still possible, the firm noted.
More than 70% of drug overdose deaths in the US are down to opioid analgesics, so the development of those harder to abuse “is helpful in addressing the public health crisis of prescription drug abuse in the US,” noted Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
The FDA has requested post-marketing studies to assess the effects of the abuse-deterrent features on the risk for abuse of Hysingla ER and the consequences of that abuse in the community.
Also, the drug is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to healthcare professionals educational programs on how to safely prescribe opioid analgesics and to provide information to patients on their safe use, storage, and disposal.
Purdue said it expects to launch Hysingla ER in the US in early 2015.