FDA approves Purdue's opioid analgesic Hysingla ER

The US Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Hysingla ER, from privately-held Purdue Pharma, has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

While Hysingla ER has the same active ingredient (hydrocodone) as Zogenix’ (Nasdaq: ZGNX) Zohydro ER, the only other approved extended-release hydrocodone product, there are important differences between the two, according to the FDA. Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not. Also, Zohydro ER is taken every 12 hours, and so comes in lower dosage strengths than Hysingla ER, which is taken every 24 hours. The FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER.