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Positive Long-Term Results Reported for Once-Daily Hydrocodone (Hysingla ER)
Positive data from a long-term safety and efficacy study of Hysingla ER (Purdue Pharma), a once-daily hydrocodone bitartrate tablet formulated with abuse-deterrent properties, were presented May 13 at the 34th annual American Pain Society scientific meeting, held in Palm Springs, California.
The study found that treatment with Hysingla ER resulted in improvements in and the maintenance of chronic pain relief, as well as other outcome measures, throughout the 76-week treatment period in patients with chronic pain without the continual need for dose increases.
The open-label study measured the safety, efficacy, and other outcomes of Hysingla ER (20, 40, 60, 80, and 120 mg/day) in patients with moderate-to-severe chronic pain. A total of 106 opioid-naïve and opioid-experienced patients participated in the study.
Treatment-emergent adverse events were typical of those associated with mu-opioid agonist treatments, the most common being constipation, nausea, upper respiratory tract infections, and fatigue. No abuse or diversion of the study drug was reported, and no apparent safety concerns were indicated by audiologic, clinical laboratory, and electrocardiographic assessments. Seven patients discontinued treatment because of an adverse event.
Hysingla ER is the only hydrocodone product recognized by the FDA as having abuse-deterrent properties that are expected to deter abuse via chewing, snorting, or injection. However, the abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible. With parenteral abuse, the inactive ingredients in Hysingla ER can result in death, local tissue necrosis, infection, pulmonary granulomas, and an increased risk of endocarditis and valvular heart injury.
Hysingla ER is indicated for the management of pain that is severe enough to require daily, around-the-clock, long-term opioid treatment in patients for whom alternative treatment options are inadequate.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, Hysingla ER should be reserved for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, are not tolerated, or would be otherwise inadequate to provide sufficient pain management. Hysingla ER is not indicated as an as-needed analgesic.
Source: Purdue Pharma; May 13, 2015.