1. Scrip
  2. >>New Products

Purdue's reformulated OxyContin gets US panel backing on second try

 
• By Sue Sutter

Purdue Pharma's reformulated OxyContin (oxycodone extended-release) may be less susceptible to abuse and manipulation than the currently marketed version, but risk management plans and postmarketing studies will be critical to determining whether the formulation is actually safer, the US FDA's outside experts have said.

Purdue Pharma's reformulated OxyContin (oxycodone extended-release) may be less susceptible to abuse and manipulation than the currently marketed version, but risk management plans and postmarketing studies will be critical to determining whether the formulation is actually safer, the US FDA's outside experts have said.

The anaesthetic and life support drugs and drug safety/risk management advisory panels voted 14 to four, with one abstention, that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 New Products

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By Kevin Grogan

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

 
• By Andy Smith

The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.

Sanofi Plays It Safer With Blueprint Buy After Bumpy 2025

 
• By Kevin Grogan

But the French major is still keen on early-stage M&A.

More from Scrip

Executives On The Move: Three New CEOs And CFOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Mitsubishi Tanabe Pharma and MC2 Therapeutics, plus MindMed acquires chief financial officer from Longboard Pharma.

Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 
• By Sushmita Panda

In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.

Deal Build-Up Amid Early ‘Deep’ Response For IGI’s Trispecific In Myeloma

 
• By Anju Ghangurde

IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?