Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate) Nasal Spray Receives the US FDA’s Approval for the Treatment of Migraine

September 7, 2021 Auto Bot approval, FDA, Migraine, regulatory 0

Shots:

  • The approval is based on the P-III STOP 301 trial evaluates Trudhesa (0.725 mg/spray) in 5650+ patients with migraine with or without aura for 24 or 52 wks.
  • The exploratory efficacy results showed that nasal spray provides rapid, sustained, and consistent symptom relief. The therapy is well-tolerated & no serious TEAEs were observed
  • Trudhesa is the first and only therapeutic to use Impel’s pod technology to deliver DHE to the vascular-rich upper nasal space. The product is expected to launch in early Oct’21 & will be available through Trudhesa Direct and the copay program

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: PR Newswire

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