BI-44370 TA / Boehringer Ingelheim - LARVOL DELTA

Safety evaluation of oral calcitonin-gene-related peptide receptor antagonists in patients with acute migraine: a systematic review and meta-analysis. (PubMed, Eur J Clin Pharmacol) - "Despite oral CGRP receptor antagonists posing a significantly higher risk of AEs when compared to placebo, CGRP receptor antagonists have a favorable safety profile compared to triptans. Our findings inform strategies to enhance safety and tolerability in the treatment of acute migraine."

Journal • Retrospective data • Review • CNS Disorders • Fatigue • Migraine • Pain • Xerostomia

Gepants for abortive treatment of migraine: A network meta-analysis. (PubMed, Brain Behav) - "Gepants were effective for abortive treatment of migraine. The most effective treatment of gepants for migraine might be olcegepant which were administrated transvenously. And all of gepants were safe for migraine treatment with single dose."

Journal • Retrospective data • CNS Disorders • Migraine • Pain

Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses of BI 44370 BS Solution in Healthy Male Volunteers (clinicaltrials.gov) - P1; N=23; Completed; Sponsor: Boehringer Ingelheim

New P1 trial • Biosimilar

Pharmacokinetics of the CGRP-receptor antagonist BI44370 during and between migraine attacks (IHC 2011) - P1, N=19; The lag time (tlag) of BI44370 was delayed by 15min & tmax was prolonged by 0.5hr vs. migraine-free period; Cmax was achieved within 1hr in 14 pts (87.5%) when given during a migraine-free period vs. 11 (61.1%) during migraine headache; AUC0-2 was reduced by 45% during migraine attack; The reductions of Cmax (24%) & AUC0-∞ (16%) were not statistically significant; Terminal elimination half-life was not affected

Migraine