The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without aura, in adult patients.
The US regulator has issued a complete response letter to Satsuma – a subsidiary of Japan’s Shin Nippon Biomedical Laboratories (SNBL) – citing chemistry, manufacturing, and controls (CMC) issues as the main reasons for the rejection.
