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BioDelivery hopes modified REMS will put cancer pain drug Onsolis in retail pharmacies

This article was originally published in Scrip

Executive Summary

BioDelivery Sciences International reported that discussions with the US FDA on a modified risk evaluation and mitigation strategy (REMS) programme for its currently marketed drug for breakthrough cancer pain, Onsolis (fentanyl buccal soluble film), focus on "a few remaining components". The company is hopeful that modifying the REMS, among other changes, will allow for dispensing of Onsolis from retail pharmacies.



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