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Zohydro ER (Extended-Release Hydrocodone) Approved by FDA

posted Oct 26, 2013, 8:47 AM by Victor   [ updated Oct 26, 2013, 8:56 AM ]
Zohydro ER hydrocodone extended release logo
A new extended-release hydrocodone medication has been approved by the FDA. Zohydro ER has become the first medication containing only hydrocodone to be marketed in the U.S. and will be available in dosages of up to 50 mg of hydrocodone. Hydrocodone is an opioid that is often found in combination with acetaminophen in painkillers such as Vicodin, Lortab, and Norco. Zohydro ER will offer prescribers an additional therapeutic option to treat around-the-clock chronic pain in patients who can't tolerate other extended-release opioid preparations. As a pure hydrocodone product, Zohydro ER has a high potential of being abused. In late 2012, a panel of pain experts advised the FDA to reject Zohydro because of its abuse potential, voting 11-2 against approval of the drug.
Zohydro ER (Extended-Release Hydrocodone) Approved by FDA
October 25, 2013


Zogenix Inc. (ZGNX) won approval to sell the first painkiller made of pure hydrocodone as U.S. regulators recommended restrictions on popular combination treatments with the drug. The decision helped Zogenix shares climb the most in eight months.

The Food and Drug Administration cleared the San Diego-based company’s Zohydro for the management of pain severe enough to require continuous, long-term treatment, the agency said today in a statement. Zohydro is intended as an alternative to drugs including Vicodin that mix hydrocodone with less-potent medicines such as acetaminophen.

Zogenix is counting on the painkiller to boost its $44 million in 2012 revenue from sales of a migraine treatment Sumavel. FDA advisers recommended in December that Zohydro not gain market clearance until the agency examined greater measures to curb opioid abuse. The medicine doesn’t contain tamper-proof technology that other drugmakers are using to prevent crushing and snorting of their pills, such as closely held Purdue Pharma LP’s OxyContin.

The FDA asked Zohydro to study the drug’s abuse potential while it’s on the market, the agency said in the statement.

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