1. Pink Sheet

Pfizer’s Troxyca And The Limits Of Advisory Committee Review For Opioids

 
• By Michael McCaughan and Laura Helbling

FDA approved Pfizer’s oxycodone/naltrexone extended release opioid with abuse deterrent claims similar to Embeda. That isn’t the label FDA’s advisory committee supported.

FDA’s approval of Pfizer’s Troxyca (oxycodone/naltrexone) is a quiet milestone: the first new opioid formulation to clear the agency since FDA updated its policy regarding reviews of the products in light of the prescription drug abuse crisis.

Under FDA’s February opioid action plan, the agency committed to bring most new opioid panels to committee prior to approval. The recently enacted Comprehensive Addiction Recovery Act codified that policy, but in much blunter form: FDA is directed to bring all opioid formulations to the panel prior to approval unless it is willing to explain why the public health was served by skipping the stop

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