Purdue Pharma submits NDA for hydrocodone bitartrate tabs

STAMFORD, Conn. — Purdue Pharma on Wednesday announced that it filed a new drug application with the Food and Drug Administration to market a hydrocodone bitartrate tablet.

The pain medication was formulated to incorporate abuse-deterrent technology, making the drug more difficult to manipulate for the purpose of abuse, the company said. Data from clinical trials of the investigational medicine were presented at the 33rd Annual Scientific Meeting of the American Pain Society in Tampa, Fla.

"Healthcare professionals need an array of therapeutic options in order to individualize the care they provide to their patients with chronic pain,” said Todd Baumgartner, MD, MPH, Vice President of Regulatory Affairs and Chief Medical Officer at Purdue Pharma. “If approved by the FDA, we believe this product will be a valuable therapy for use in treating chronic pain that is also expected to deter misuse and abuse by various routes of administration.”

Hydrocodone products are the most commonly prescribed opioid analglesics in the United States and also are the most widely abused, according to the Substance Abuse and Mental Health Services Administration. Hyrdrocodone formulations that are currently available don't incorporate abuse deterrent technologies, Purdue noted.

 

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