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Senators challenge FDA over approval of potent painkiller

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US senators Kirsten Gillibrand (NY), Dianne Feinstein (CA), Joe Manchin (WVA) and Amy Klobuchar (MN) have banded together to find out why the FDA approved the powerful painkiller Zohydro without mandating the same safeguards used for Oxycontin and other opoid drugs, calling the move “irresponsible” in a joint letter to FDA Commissioner Margaret Hamburg.

They also noted that the current formula for Zohydro is “pure hydrocodone, and about 5-10 times more potent than Vicodin.” Hydrocodone overdoses were linked to at least 27 deaths on Long Island, alone last year.

While, drugmakers have now made Oxycodin pills “impossible to pulverize,” the new drug can be crushed, making it easier for abusers to either inhale or inject it with syringes in order to get high more quickly.
Zohydro is meant to be taken “only when pain is severe enough to require daily around-the-clock, long term treatment that cannot be addressed by other medication,” according to an FDA statement.

Meanwhile, Stephen Farr, president of Zogenix, Inc., which manufactures the drug stated that the the company is “committed to advancing its program to develope an abuse-deterrent formula for Zohydro ER, and are moving along as fast as possible.

Zohydro is expected to hit the marketplace early next year.



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