Key clinical point: Self-administered single-dose subcutaneous (SC) injection of diclofenac sodium (50 mg/mL) complexed with hydroxypropyl-β-cyclodextrin (HPβCD) is safe and effective for the treatment of acute migraine attacks in patients with moderate-to-severe migraine pain.
Major finding: After 2 hours of injection, 46.7% of patients were pain-free in the 50 mg diclofenac/HPβCD group, with the percentage being significantly higher than that in the placebo group (16.1%; P = .01). Most treatment-emergent adverse events were mild.
Study details: The findings are from a multicenter, phase 2, dose-finding pilot study including 122 adult patients experiencing 2-8 migraine attacks/month with moderate-to-severe pain who were randomly assigned to receive diclofenac/HPβCD (25, 50, or 75 mg) or placebo.
Disclosures: The study was sponsored by IBSA Institut Biochimique S.A. (Switzerland). Some authors declared serving as advisory board members, consultants, or speakers, or receiving honoraria for clinical investigation studies, travel and research grants, or personal fees from various sources.
Source: Geppetti P et al. Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study. Cephalalgia. 2022 (Apr 26). Doi: 10.1177/03331024221093712