1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Approval Standards

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Approval Standards

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 
• By Derrick Gingery

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

More from Pathways & Standards