FDA approves Hysingla ER for Chronic Pain-Purdue Pharma

The FDA has approved Hysingla ER (hydrocodone bitartrate extended-release), from Purdue Pharma,a once-daily, single-entity medication formulated for Chronic Pain - specifically for 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 the first and only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection. However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible.

Approval is based on Phase III results, including a study in which the majority of patients treated with hydrocodone bitartrate dosed once-daily experienced at least a 30% improvement in pain intensity. Nearly half of patients (48%) achieved a 50% improvement with hydrocodone bitartrate. Most common treatment-emergent adverse reactions (greater than or equal to 5%) reported by patients treated with Hysingla ER in the clinical trials were constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.