Zogenix Gets FDA Approval For Zohydro ER

(RTTNews) - Zogenix, Inc. (ZGNX) said Friday that the U.S. Food and Drug Administration has approved Zohydro ER extended-release capsules, an opioid agonist, extended-release oral formulation of hydrocodone without acetaminophen, 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.

Zogenix expects to launch Zohydro ER in about four months.

Zohydro ER is the first extended-release formulation hydrocodone therapy without acetaminophen. The use of products containing acetaminophen in high doses over long periods of time has the potential for causing liver injury.

Zohydro ER capsules will be available in six dosage strengths ranging from 10 mg to 50 mg with dosing every 12 hours.

Zohydro ER is classified as a Drug Enforcement Agency Schedule II drug, making it subject to stricter prescribing and dispensing rules compared to the immediate-release hydrocodone-acetaminophen combination products, which are currently classified as Schedule III drugs.

Zohydro ER was studied in over 1,100 people living with chronic pain who participated in the pivotal Phase 3 efficacy study or an open-label Phase 3 long-term safety study. The efficacy study that enrolled over 500 subjects with chronic low back pain met the primary endpoint in demonstrating that treatment with Zohydro ER resulted in significantly improved chronic pain relief compared to placebo. The key secondary endpoint was also achieved: a significantly higher number of subjects experienced at least 30% improvement in pain intensity from screening to end of study.