USFDA Raises Doubts Over Effectiveness Of Purdue Pharma's Fast-Acting Painkiller

Concerns over possible errors have been expressed by the U.S. Food and Drug Administration staff in administering Purdue Pharma's fast-acting oxycodone painkiller that could result in inadequate relief. Studies have revealed the drug is designed to be taken every 4-6 hours on an empty stomach as the absorption of oxycodone from the drug can be substantially delayed in the presence of food. The food effect was found to reduce the effectiveness of the drug. To prevent the action of food effect Purdue proposed to make clear on the label that the opioid painkiller is to be taken on an empty stomach.

Reviewers said inadequate pain control caused by presence of food could lead to overdosing. Opioid drug abuse can produce euphoric highs and even disrupt the parts of the brain that control breathing.

A panel of outside advisers is scheduled to meet to recommend whether the drug should be approved. The company said it had acquired an experimental chronic pain drug for up to $213 million. FDA staff are also expected to post a review of a longer-acting version of oxycodone, developed by Collegium Pharmaceuticals Inc.

Medindia