×

OxyContin maker bows out of meeting

WASHINGTON (AP) – The makers of the potent painkiller OxyContin have pulled out of a federal meeting to review the company’s harder-to-abuse version of the much-debated drug.

An executive for Purdue Pharma says the company wants more time to review and analyze its data. As a result, the company has withdrawn its application that was slated to be reviewed before a Food and Drug Administration committee next week.

“Given the complexity of epidemiological research and the unprecedented nature of this exercise, we’ve made the decision to complete additional analyses,” said Dr. Richard Fanelli, the company’s head of regulatory affairs, in an emailed statement.

FDA meetings are typically planned months in advance and cancellations are highly unusual. The agency must present detailed evaluations of the company’s application and coordinate travel for outside experts who advise the federal government.

OxyContin was re-formulated in 2010 to discourage patients from crushing the tablets for snorting or injection. Purdue Pharma discontinued the older version of its blockbuster drug, which was long associated with problems of addiction, overdose and death.

Next week’s two-day meeting was intended to evaluate whether those abuse-deterrent features actually translate into reduced rates of abuse by pain patients.

The FDA required Stamford, Connecticut-based Purdue Pharma to conduct long-term, follow-up studies tracking rates of abuse, addiction, overdose and death with the updated drug.

Newsletter

Today's breaking news and more in your inbox

I'm interested in (please check all that apply)
Are you a paying subscriber to the newspaper? *
   

Starting at $2.99/week.

Subscribe Today