Pain Killer with Built-in Abuse Deterrence Gets FDA Clearance

(FDA.gov)

A prescription pain killing drug developed by Pfizer Inc. in New York and Acura Pharmaceuticals Inc. in Palatine, Illinois has received marketing approval from the U.S. Food and Drug Administration. Oxecta, an opioid analgesic tablet made from oxycodone hydrochloride (HCl), contains ingredients developed by Acura Pharmaceuticals to deter tampering that leads to misuse or abuse of the drug.

Oxycodone HCl is a drug prescribed for chronic moderate to severe pain, but is also a legally controlled substance because of its strong potential for abuse or addiction. A common brand-name version of the drug is Oxycontin.

Oxecta contains ingredients made by Acura Pharmaceuticals to deter abuse of drugs by intravenous injection of dissolved tablets or capsules, nasal snorting of crushed tablets or capsules, and intentional swallowing of excess quantities of tablets or capsules. Pfizer licenses this technology from Acura for Oxecta.

Acura’s technology turns the active opioid ingredients into a gel, if a user tries extract, dissolve, and filter the active ingredients. The gel makes the solution difficult to inject with a syringe. Acura’s ingredients also irritate nasal passages if a user tries to snort the opioid.

In addition, Acura adds niacin as one its ingredients that discourages swallowing excess quantities of the drug. Niacin induces discomforting reactions such as intense flushing, itching, sweating or chills, and headache.

Read more: Non-Narcotic Natural Pain Killer Synthesized

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