Intranasal DHE safe and effective option for migraine, finds clinical Trial

Delhi: Intranasal dihydroergotamine (DHE) that targets the upper nasal region is a well-tolerated and effective treatment for migraines, according to results from a phase 3 clinical trial. The results suggest that delivery to the upper nasal space may provide a safe and effective alternative to the intramuscular infusions or intravenous injections whilst providing the reliable efficiency, speed, and potency of the long-established DHE molecule. 

The study results were presented at the virtual annual meeting of the American Headache Society.

Migraine is a common, disabling headache disorder affecting 1 billion people globally. Despite the approval of several. novel abortive treatments, patients remain dissatisfied with their current therapies and there is a high unmet need for safe and effective migraine treatment options.

Due to its high response rate and sustained efficient DHE has been recommended for the treatment of migraine (since 1946). However, originally, this was available only by injection that could result in greater systemic side effects such as nausea and vomiting. Stephen Shrewsbury, chief medical officer of Impel NeuroPharma, and colleagues, reported the safety, tolerability, patient acceptability and efficacy of POD-DHE mesylate (INP104) over 24 weeks from the pivotal, phase 3 STOP 301 clinical trial.