‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity

‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity

Source: 
RAPS.org
snippet: 

Thanks to the last user fee agreement, known as the FDA Reauthorization Act of 2017, the agency can now explain why a newly approved orphan drug is clinically superior to previously approved orphan drugs and therefore should be awarded seven years of orphan drug exclusivity.

Since 2017, FDA has only explained how five treatments can be considered clinically superior, with the latest coming last Friday for Neurelis Pharmaceuticals’ Valtoco (diazepam nasal spray). FDA explains how diazepam was previously approved as a gel administered rectally whereas Valtoco’s intranasal route of administration is easier to use.