FDA Denies use of blue dye in an attempt to stop opioid abuse
FDA Nixes Use of Blue Dye in Opioid Painkiller
July 31, 2017
The U.S. Food and Drug Administration (FDA) voted overwhelmingly not to approve a version of Intellipharmaceutics International’s Rexista opioid that would attempt to discourage abuse by staining potential users with a blue dye that would be released upon a tamper attempt.
The FDA rejected the measure on the grounds that it would not mitigate the abuse of the drug via injection. The agency also scolded the drugmaker for not including enough information in its application about human studies that address the potential for the abuse of Rexista.
Rexista’s maker also included in the drug an irritant that would allegedly make it less attractive to those who wished to inhale it.
Rexista is a powerful opioid medication that is equivalent to OxyContin. It is intended for the treatment of severe, constant pain.
Intellipharmaceutics responded to the advisory panel’s decision by stating that it would commence further studies on the drug.
The abuse of prescription opioids kills about 30,000 Americans every year.
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