FDA-backed study provides path forward for Probuphine

Titan Pharmaceuticals and its partner Braeburn Pharmaceuticals on 3 March said they have agreed in principle with the US FDA on the design of a trial to support the resubmission of the new drug application (NDA) for Probuphine (buprenorphine hydrochloride/ethylene vinyl acetate), a subdermal implant under investigation as a maintenance treatment of opioid dependence.

Titan Pharmaceuticals and its partner Braeburn Pharmaceuticals on 3 March said they have agreed in principle with the US FDA on the design of a trial to support the resubmission of the new drug application (NDA) for Probuphine (buprenorphine hydrochloride/ethylene vinyl acetate), a subdermal implant under investigation as a maintenance treatment of opioid dependence.

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

More from Archive

More from Scrip

Merck KGaA Moves Closer To Sealing SpringWorks Buy

 
• By 

The German group could pay $3.5bn to get hold of the US firm and its two approved products.

In Brief: Mosaic Gains Two Clinical-Stage Oncology Assets From Astex

 

Mosaic Therapeutics has in-licensed two clinical-stage oncology assets from Astex Pharmaceuticals to develop proprietary combination therapies for hard-to-treat cancers. The deal includes up to a 22% equity stake for Astex, future revenue sharing, and a planned clinical study in 2026.

Executives On The Move: Ten CMOs And Three CEOs and CFOs Each Among This Week’s Changes

Recent moves in the industry include C-suite changes at Dyne Therapeutics, City Therapeutics and ProQR Therapeutics, plus Madrigal Pharmaceuticals acquires chief medical officer from Novartis.