STAMFORD, Conn. — Purdue Pharma L.P. has received approval from the Food and Drug Administration for Hysingla ER (hydrocodone bitartrate) extended-release tablets CII, an opioid pain reliever.
Purdue said Thursday that the once-daily, single-entity medication is formulated using its Resistec proprietary ER solid oral platform. According to the company, Hysingla ER is the first and only hydrocodone product recognized by the FDA as having abuse-deterrent properties, which are expected to deter misuse and abuse via chewing, snorting and injection, though not by intravenous, intranasal and oral routes.
Hysingla ER doesn’t contain acetaminophen, the overuse of which has been reported to be a chief cause of acute liver failure in the United States, Purdue noted, adding that prescription products containing hydrocodone and acetaminophen are the most prescribed and among the most widely abused medications in the nation.
"We are proud to offer health care professionals and chronic pain patients another treatment option," stated Mark Timney, chief executive officer of Purdue Pharma. "Hysingla ER is the third product in our pain management portfolio to receive an FDA label describing its abuse-deterrent characteristics. These innovations are an important step forward in helping meet patients’ needs while also working to deter misuse and abuse."
The U.S. launch of Hysingla ER is slated for early 2015, in dosage strengths of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg, to be taken once every 24 hours.
Hysingla ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, Purdue said.
"The burden of chronic pain and the abuse of prescription medications are both pressing societal problems," commented Charles Argoff, M.D., professor of neurology at Albany Medical College and director of the Comprehensive Pain Center at Albany Medical Center in New York. "Opioids are an essential tool in our arsenal of medical treatments options, so greater availability and use of opioid analgesics with abuse-deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications. Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis."
