Fire&Water
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WASHINGTON -- The FDA has approved Zohydro ER (hydrocodone bitartrate extended release tablets) for long-term treatment of refractory severe pain.
Zohydro, a Schedule II drug, is the first single-entity hydrocodone product approved by the FDA. Other hydrocodone opioids are typically combined with a non-opioid analgesic such as acetaminophen.
The drug is intended for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate, the agency noted.
"Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain," according to the FDA.
The drug is not indicated for "as-needed" treatment.
story continues: http://www.medpagetoday.com/PainManagement/PainManagement/42493
Right after "Zohydro" was passed for approval today, FDA wants to re-schedule Hydrocodone from schedule III to schedule II.
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