FDA panel: Not enough data to OK "abuse-deterrent" opioid

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TRENTON, N.J. (AP) — A panel of Food and Drug Administration advisers voted against approving a new opioid painkiller with a unique feature for deterring abuse: It releases a deep-blue dye if someone tries to get high by crushing, chewing or snorting pills.

Panelists voted overwhelmingly against approving Intellipharmaceutics International's generic version of extended-release Oxycontin, a key drug in the U.S. opioid addiction epidemic. The FDA usually follows its advisers' advice.

Doctors and scientists raised many concerns about the dye's safety for intended patients, and its effectiveness in deterring opioid abusers. Most said the company hadn't done enough studies of the drug.

Some suggested blue stains around the mouth or nose from trying to abuse the drug could become popular among addicts. Others said the dye's "Scarlet Letter" shaming approach was insensitive.

Executives with Toronto-based Intellipharmaceutics had earlier said they believed the blue stains, which would take at least 30 minutes to scrub off the skin, would serve as an early-warning system to family and friends that an opioid addict was abusing drugs.

But the FDA advisers, a combined group of drug safety and pain management experts, voted 22-1 against recommending the FDA approve sales of the pills, which Intellipharmaceutics has tentatively named "Rexista."

The panel also voted that the company hadn't provided enough data to show that addicts couldn't find a way to convert the pills' active ingredient, oxycodone, into a liquid that could be injected.

Advisers noted that the company hadn't studied issues such as whether the nasal irritant in the pill would prevent abusers from trying to snort it after crushing and whether the blue dye would discourage abuse attempts.

"I can see Smurf parties and blue lollipops suddenly becoming popular," said Dr. Melinda Campopiano, a senior medical adviser at the U.S. Substance Abuse and Mental Health Services Administration.


Follow Linda A. Johnson at https://twitter.com/LindaJ\_onPharma .

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