Martindale brands PRAC methadone reformulation demand unfair
This article was originally published in Scrip
Executive Summary
Alleged misuse of an oral methadone formulation by Norwegian drug addicts has highlighted a new regulatory risk that pharma companies now face. It appears that though pharma companies have to show their drugs have more than a favorable risk:benefit ratio when used properly, they must also be formulated so as to mitigate risk of harm when taken inappropriately.