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    Abuse-Deterrent Opioid Rexista Makes Misusers Blue—Literally

    How one opioid abuse deterrent could make it easy to identify misuse.

    Update 9/25

    The FDA announced that it is denying Intellipharmaceutics approval on its drug Rexista. According to a statement from the company making the drug, the FDA wants more information regarding its abuse-deterrant properties through nasal and oral routes. The FDA also had concerns with the blue dye used in the drug, and is requiring the company to provide additional information about it.

    The move comes after an FDA advisory commitee voted in July against the drug's approval, 22 to 1.

    The agency also rejected the name Rexista for the drug, and is asking Intellipharmaceutics to submit alternate names for the drug, now simply referred to as Oxycodone ER. The company has one year to answer the FDA's requests.

    Original article follows 

    Taken as prescribed, Rexista Oxycodone XR acts like other pain-easing medications. But try to crush the tablets in order to snort the medication or dissolve them in liquid for injecting and the result will be a blue, sticky, viscous gel that is difficult to handle.

    The opioid analgesic, which the FDA is considering for approval, is like several others already on the market that have difficult-to-use properties if they are manipulated improperly. But the blue dye in the extended-release tablet is something new, said Isa Odidi, PhD, CEO and Co-Chief Scientist of Intellipharmaceutics International, the Toronto-based company developing Rexista.

    “The purpose of the blue dye is to provide an early warning system,” Odidi said. “The moment you try to chew it, it creates this intense blue color in the mouth.”

    That, he said, creates “the ability to see quickly if someone is trying to abuse the product.”

    Related article: How Should Opioid Addiction Be Treated?

    What’s more, alcohol does not change Rexista’s release of the drug, Intellipharmaceutics said. That prevents “dose dumping,” or using alcohol to amplify its effect. Odidi added that Rexista has an advantage over similar opioid products because it has been shown to have no “food effect,” and can be taken with or without meals.

    Abuse-deterrent opioids

    Rexista is intended for the continuous management of moderate to severe pain. If approved, it will join a growing list of opioid formulations aimed at curbing opioid abuse, an epidemic that kills 91 Americans each day, according for the CDC. The FDA encourages the development and advancement of abuse-deterrent opioids as part of its overall Opioid Action Plan.

    “The FDA looks forward to a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that lack abuse-deterrent properties,” the agency says on its website. The FDA agency lists 10 opioids that are permitted to carry the “abuse deterrent” label.

    These drugs use various methods to curb abuse, such as additives that make the drugs unpleasant to chew or snort. With Rexista, the gel is formed by a polymer that activates when crushed and exposed to liquid or moisture.

    Related article: Alternatives to Opioids

    Odidi said he hopes the blue coloration strategy will “introduce a new standard” to the industry. It can be especially effective in alerting people to first-time abusers or those who know little about opioids, he said.

    Is blue enough?

    However, Stephen Hoag, PhD, Professor of Pharmacy Science at the University of Maryland School of Pharmacy, said serious drug addicts would not likely be hindered by the blue coloration. But he agreed that the presence of the dye could make it more difficult for casual users to abuse the drug without being noticed.

    “If a kid has blue all over his face, that would be very useful information for the parents,” he said.

    Michael Smith, PharmD, BCPS, Clinical Assistant Professor in the Department of Clinical Pharmacy at the University of Michigan College of Pharmacy, said the blue dye may have a limited effect.

    “I don’t know how effective it will end up being,” he said. “I think it will stop some people from abusing it, but it certainly won’t stop everybody.”

    Up next: Troubles ahead for the new drug

    Ken Valenti
    Ken Valenti is a freelance writer based in Westchester County, NY.

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