Ahead of the Bell: Zogenix rises after FDA drug OK
Zogenix jumped in premarket trading Monday after the drugmaker received regulatory approval for its extended-release painkiller.
The Food and Drug Administration approved the pill Friday for people who need daily, around-the-clock treatment and cannot be treated with other drugs. Zohydro ER contains hydrocodone, a widely-abused prescription painkiller.
Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis and migraines. The drugs mix hydrocodone with non-addictive pain relievers like aspirin and acetaminophen.
The new drug from San Diego pharmaceutical is the first pure hydrocodone drug approved in the U.S. The company said the use of products containing acetaminophen in high doses over long stretches of time can cause liver damage.
The approval came as a surprise since an FDA panel of outside advisers gave the drug an overwhelmingly negative review last year. The panel of pain specialists voted 11-2, with one abstention, against approving the drug. It questioned the need for a new form of one of most widely-abused prescription drugs in the United States.
The approval also came a day after the FDA said it would support stronger restrictions on combination drugs containing hydrocodone.
Shares of Zogenix Inc. jumped 7.6 percent, or 23 cents, to $3.27 in pre-market trading Monday. The stock has traded between $1.11 and $3.45 over the past year.