Collegium Targets Remoxy ER Through Citizen Petition Process – Again

 
• By Michael Cipriano
  
Generate a summary of this article
Listen to this article
Beta

Citizen petition resembles July 2016 petition targeting extended-release oxycodone products, but this time names the products it's worries about.

Vertical stack of multicolor office binders with Statements tags 3D rendering

Collegium Pharmaceutical Inc. is arguing for FDA to apply robust standards in its review of Pain Therapeutics Inc.' Remoxy ER (oxycodone controlled-release) in a citizen petition calling for the agency to only approve the drug and other extended-release (ER) oxycodone products if their abuse-deterrent properties are as strong as those of Xtampza ER (oxycodone, extended-release), in what appears to be the drugmaker's second petition targeting Remoxy.

The April 9 petition, written by Hyman, Phelps & McNamara attorney Kurt Karst on behalf of Collegium, calls for...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Drug Safety

UK MHRA First-Half New Drug Approvals Show Overwhelming Use Of EU Reliance Procedures

 
• By Ian Schofield

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

EMA Probe Prompts New Safety Measures For Decades-Old Drug Metamizole

 
• By Neena Brizmohun

The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.

Overcoming The Challenges Of Developing Hearing Loss Therapies

 
• By Ian Schofield

Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.

More from Pink Sheet

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
• By Sue Sutter

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Nancy Tests New Podcast Template

 
• By Derrick Gingery

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

PinkSheet-R&D-Free: ‘Ranking’ article that includes different Composer content

 
• By Nabil, Olga Zviezdicheva, Reed Miller, Mary Jo Laffler, Ian Schofield, João Andrés-Ruíz de la Fontaine-LeBlanc, Chloë Anastasía-Stojanović del Castillo-Ribeirão, and Nabil

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.