FDA Approves Zohydro ER For Managing Severe Pain

The Food and Drug Administration Oct. 25 approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for managing pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved, single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product, the agency said. The product is manufactured by San Diego-based Zogenix Inc.

Schedule II drugs only can be dispensed through a physician’s written prescription and no refills are allowed, the FDA said. There also are stringent recordkeeping, reporting ...