Abbott's Vicodin CR draws FDA "complete response"
This article was originally published in Scrip
Executive Summary
The US FDAhas issued a "complete response" letter to Abbottfor a controlled-release formulation of the pain killer Vicodin (hydrocodone plus acetaminophen). The company will discuss the letter with the agency and provide an update "when appropriate". If approved, Vicodin CR would be the first extended-release formulation of hydrocodone with acetaminophen, providing pain relief for more than 12 hours. Currently available short-acting formulations of hydrocodone with acetaminophen have to be taken every four to six hours. Although Abbott did not provide specifics about the complete response letter, the agency may have concerns about the new formulation's abuse potential and could require a risk evaluation and mitigation strategy (REMS). Hydrocodone is the most frequently prescribed opiate in the US and diversion and abuse have escalated in recent years.