Venango task force discusses drug Opana on FDA watch list

By Sally Bell Staff writer

Opana, a drug that the Food and Drug Administration is thinking of banning for its addiction potential, is turning up in Venango County assessments.

Particularly problematic is the drug’s extended-release formula, which drug users are crushing and snorting for a powerful high, members of the Venango County Drug Overdose Task Force said at the panel’s meeting Friday.

Opana ER is the brand name for oxymorphone hydrochloride extended release and is used in the clinical setting for pain management.

On the street, the drug is pricey to buy at about $70 per pill in an illegal sale, said Todd Gruber, Venango County’s case manager substance abuse supervisor and a task force member.

Some clients at Turning Point rehabilitation center in Franklin have reported abusing Opana, said Dave Kresenske, the center’s clinical director.

“This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse,” the FDA said in a press release Thursday.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” FDA Commissioner Scott Gottlieb said in the press release.

Several factors figured into the FDA’s decision to think about removing the drug, which is manufactured by Endo International, from the market.

A reformulation of Opana after its release in 2006 prompted a shift in the route of abuse, and injection of the drug is being associated with outbreaks of HIV and hepatitis, the FDA said.

The company is asking that Endo voluntarily remove Opana ER from the market. If the company does not, the FDA stated in its release that the agency would “take steps to formally require its removal by withdrawing approval.”

In its own press release, Endo responded to the FDA this week by saying that the company is reviewing the FDA’s request and is “evaluating the full range of potential options as we determine the appropriate path forward.”