WASHINGTON _ The Food and Drug Administration has approved a stronger, single-ingredient version of the painkiller hydrocodone, the widely-abused prescription medicine for chronic pain.
The agency said it approved the Zogenix (
NASDAQ:ZGNX,
Stock Forum) pill Zohydro for patients with pain that requires, daily, around-the-clock treatment that cannot be addressed with other drugs.
The approval comes as a surprise since the agency's own panel of outside advisers gave an overwhelmingly negative review of the product last year. The FDA's panel of pain specialists voted 11-2 against approving the drug last December, questioning the need for a new form of one of most widely-abused prescription painkillers in U.S.
The FDA announcement also comes just a day after the agency said it would recommend stronger controls on combination drugs containing hydrocodone, such as Vicodin.