Purdue Pharma today presented data from a long-term (76 week) safety and efficacy study of Hysingla ER, a once-daily, single-entity hydrocodone bitartrate tablet formulated with abuse-deterrent properties. Results of this and two other studies sponsored by Purdue are being presented at the 34th Annual American Pain Society Scientific Meeting in Palm Springs, California, May 13-16.
The research found that treatment with Hysingla ER resulted in improvements in and 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 increase.
The long-term, open-label study with up to a 76-week maintenance period measured the safety, effectiveness and other outcomes of Hysingla ER (20, 40, 60, 80, 120 mg/day) treatment 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 observed in the study were typical of those associated with mu opioid agonist treatments, the most common being constipation, nausea, upper respiratory tract infection, and fatigue. There was no incidence of abuse or diversion of study drug reported, and no apparent safety concerns were revealed from evaluations of audiologic, clinical laboratory, and ECGs assessments. Seven patients discontinued the treatment due to an adverse event.
Hysingla ER is the first and only hydrocodone product to be recognized by the U.S. Food & Drug Administration (FDA) as having abuse-deterrent properties that are expected to deter abuse via chewing, snorting and injection. However, abuse of Hysingla ER by the intravenous, intranasal and oral routes is still possible. With parenteral abuse, the inactive ingredients in Hysingla can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury.
Hysingla ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment in patients for whom alternative treatment options are inadequate. Hysingla ER has the following Limitations of Use: 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., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hysingla ER is not indicated as an as-needed analgesic.
Hysingla ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, known or suspected paralytic ileus and gastrointestinal obstruction, and hypersensitivity to any component of Hysingla ER or the active ingredient, hydrocodone bitartrate.
