A new painkiller that contains the powerful narcotic hydrocodone was approved Friday by the U.S. Food and Drug Administration, just a day after the company called for tighter restrictions on such powerful painkillers, according to HealthDay News.
The new drug -- Zohydro ER (hydrocodone bitartrate extended-release capsules) -- was approved for patients with pain severe enough to require daily, 24-hour, long-term treatment and for which other pain treatments are inadequate.
It is not approved for as-needed pain relief.
Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis, migraines and other ailments. The new drug from Zogenix is the first pure, non-combination form of the drug approved in the U.S.
The approval comes as a surprise since the agency’s own panel of outside advisers gave the drug an overwhelmingly negative review last year. The agency’s panel of pain specialists voted 11-2, with one abstention, against approving the drug last December, questioning the need for a new form of one of most widely-abused prescription painkillers in U.S.
Tighter restrictions for powerful painkillers
In an effort to combat "misuse and abuse," the Food and Drug Administration is proposing new restrictions that would change regulations for some of the most commonly prescribed narcotic painkillers on the market.
The FDA's latest proposal would specifically affect hydrocodone combination pills, also known as opioids, which combine hydrocodone with less potent painkillers such as acetaminophen. One example is the drug Vicodin.
Currently labeled as Schedule III drugs, these opioids would, if the reclassification proposal is accepted, be labeled as Schedule II.
This means patients would have to have a written prescription from a doctor -- instead of a prescription submitted orally over the phone -- to access the drugs. And refills would be prohibited; patients would have to check in with the doctor to get another prescription.
Emily Sutherlin is also the Pregnancy Examiner.
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