Long-Term Safety, Efficacy Data Released for Hysingla ER

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Hysingla ER Long-Term Safety, Efficacy Data Released
Hysingla ER Long-Term Safety, Efficacy Data Released

PALM SPRINGS, Calif. — Officials with Purdue are announcing data from a long-term safety and efficacy study of hydrocodone bitartrate extended-release (Hysingla ER)) tablets with abuse-deterrent properties, at the 34th Annual American Pain Society Scientific Meeting being held this week here.

The open-label study with a 76-week maintenance period evaluated the safety and effectiveness and other outcomes of the tablets in 106 opioid-naive and opioid-experienced patients with moderate-to-severe chronic pain.

Treatment with hydrocodone bitartrate extendred-release led to improvements in and maintenance of chronic pain relief without the need for dose increase.

The most common treatment-emergent adverse events were constipation, nausea, upper respiratory tract infection, and fatigue. No cases of abuse or diversion of study drug were reported, and no safety concerns were raised from various audiologic, clinical laboratory, and ECG assessments, company officials reported.

Hysingla ER is a Schedule CII opioid agonist 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. It is supplied as 20mg, 30mg, 40mg, 60mg, 80mg, 100mg, 120mg extended-release tablets in 60-count bottles.

Reference

  1. Various authors. "Evaluation of Once-Daily Hydrocodone in Patient Subgroups and Safety and Effectiveness of Once-Daily Hydrocodone in Patients Switching from an Oral ER Morphine Regimen." Presented at: APS 2015. May 11-13, 2015; Palm Springs, California.
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