1. Pink Sheet

Polarizing Fight Looms As US FDA Seeks Comment On Abuse-Deterrent Stimulants

 
• By Michael Cipriano

Abuse-deterrent formulations have been polarizing in the opioid space; now the US FDA wants feedback on developing the formulations for central nervous system stimulants, such as ADHD drugs, which could renew debate about the value of the formulations and how the agency should weigh public health considerations when deciding whether to approve an individual product.

Two wild goats play-fight on the edge of a rock cliff with horns interlocked.
Will the fight over abuse-deterrent formulations spill into the stimulant arena?

A polarizing fight could be on the horizon following a US Food and Drug Administration announcement about exploring the development of abuse-deterrent formulations (ADFs) of central nervous system stimulants, raising the prospect that the agency will again have to wrestle with broader public health considerations as it decides whether to approve individual products, much as it has with opioids.

The FDA announced in a 20 September Federal Registernotice that it is seeking stakeholder feedback about whether and to...

More from R&D

More from Pink Sheet

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.