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Super Painkiller Needs Extra Scrutiny From FDA, NY Senator Says

Powerful painkillers being researched by Zogenix Inc. (ZGNX), a specialty pharmaceutical company, should be severely restricted if U.S. regulators decide to approve them, a New York senator said today.

Senator Charles Schumer, a Democrat, wrote Food and Drug Administration Commissioner Margaret Hamburg urging her to proceed with caution before allowing what he called “super” drugs that are 10 times more powerful than Vicodin on the market. Zogenix and at least three other companies are researching pure-form hydrocodone pain relievers, according to a statement from Schumer.

The products have never been sold in the U.S. and would be the most powerful prescription painkillers available, Schumer said. The senator urged FDA to closely track any approved hydrocodone products and take precautions to deter abuse as well as closely monitor advertising and sales.

“It’s tremendously concerning that at the same time policy makers and law enforcement professionals are waging a war on the growing prescription drug crisis, new and more powerful super- drugs could well be on their way, flooding the market,” Schumer said.

Zogenix’s product, Zohydro, began final phases of testing in March 2010, according to the company’s website. Zogenix plans to submit an application to the FDA for approval in the second quarter of 2012, Victoria Aguiar, a spokeswoman for Zogenix, said in an e-mail.

The company is attempting to develop a safer pain treatment than Vicodin, which contains acetaminophen and can cause liver toxicity, Aguiar said. Zogenix also plans to implement a risk mitigation strategy that recognizes the abuse potential of its product.

Zogenix rose less than 1 percent to $2.84 at the close in New York. The shares have declined 53 percent in the past 12 months.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.

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