Purdue Pharma has canceled an all-important discussion with FDA advisers about its latest spin on OxyContin less than a week ahead of the scheduled meeting, an uncommon move the company said will ultimately improve its odds of success.
The drugmaker was slated to appear before the FDA's panel of analgesic experts on July 7 to go over whether its new formulation of the oxycodone drug is successfully deterring abuse. But Purdue has since backed out of that meeting and canceled its supplemental application altogether, saying it wants more time to review its data.
"Given the complexity of epidemiological research and the unprecedented nature of this exercise, we've made the decision to complete additional analyses, which we now believe are essential to building the most compelling body of epidemiological evidence," Richard Fanelli, Purdue's head of regulatory affairs, said in a statement.
The process of preparing and submitting data to support drug applications commonly takes months or even years, making Purdue's last-minute realization that it needed further analysis especially unusual. Just what spurred the company's action remains unknown, and Purdue is limiting its comments on the issue to the above statement.
The FDA has for years been urging makers of painkillers to do everything they can to discourage abuse, spurring efforts to make pills more difficult to crush, melt or dissolve as the rates of deadly overdose rise around the U.S.
Purdue pulled its original extended-release OxyContin off the market in 2010, replacing it with an abuse-deterrent formulation approved the same year. Three years later, the agency signed off on an update to the drug's label that touts its difficulty to melt and inject, at the same time requiring Purdue to run postmarketing studies to prove the new formulation could meaningfully affect rates of abuse. Next week's panel meeting was meant to go offer the results of those studies.
Since the withdrawal of the old OxyContin, a host of companies have entered the field of abuse-deterrent pain drug development. Egalet ($EGLT) and Collegium Pharmaceutical ($COLL) pulled off IPOs to support their work in the field, while Pfizer ($PFE), Teva ($TEVA) and many others are pushing toward the market with hard-to-abuse painkillers.
- here's the FDA's note