King Expects Acurox Committee In April: What Are The Standards For Aversion-Based Abuse-Resistance?
This article was originally published in The Pink Sheet Daily
Executive Summary
King Pharmaceuticals expects up-or-down vote on formulation of immediate-release oxycodone with niacin. King will resubmit Acurox application after meeting.
You may also be interested in...
Drugs With Abuse Potential Should Recruit Two Types Of Patients For Trials
FDA is encouraging sponsors conducting clinical trials to assess the abuse potential of a new drug to enroll "drug-naive healthy subjects" as well as "experienced, recreational drug users who have a recent or current history of using a drug in the pharmaceutical class of the test drug.
Drugs With Abuse Potential Should Recruit Two Types Of Patients For Trials
FDA is encouraging sponsors conducting clinical trials to assess the abuse potential of a new drug to enroll "drug-naive healthy subjects" as well as "experienced, recreational drug users who have a recent or current history of using a drug in the pharmaceutical class of the test drug.
Regulatory Growing Pains: An Interview With King CEO Brian Markison (Part 2)
King Pharmaceuticals is in the center of a pivotal shift in the regulation of addictive pain therapies in the U.S. The company hopes to keep getting new products through FDA while helping to shape a class-wide opioid REMS. That is quite an agenda for 2010.