[P7.184] Incidence of Adverse Events with MAP0004 Does Not Increase with Increased Frequency of Dosing: Results from a Long-Term Phase 3 Study
Paul Winner,1Sylvia Lucas,2Biao Lu,3Emilee Connors,4Frederick Freitag,5Shashidhar Kori4
1West Palm Beach, FL, USA, 2Seattle, WA, USA, 3Irvine, CA, USA, 4Mountain View, CA, USA, 5Milwaukee, WI, USA
OBJECTIVE: To evaluate the incidence of adverse events (AEs) after administration of 1, 2, or ≥3 MAP0004 doses/month over 1 year.
BACKGROUND: The efficacy and safety of MAP0004, a dihydroergotamine (DHE) delivered through the lung via a breath-synchronized, metered-dose inhaler (TEMPO®), have been demonstrated for acutely treating migraine in placebo-controlled, double-blind trials. DHE has a long half-life and prolonged binding to 5-HT1B and 5-HT1D receptors. This post hoc analysis assessed whether an increase in AEs would occur after repeated DHE administration, because of these pharmacokinetic and pharmacodynamic properties.
DESIGN/METHODS: This analysis used AE data from an open-label study to evaluate the safety and tolerability of MAP0004. Subject-reported AEs were recorded and mapped to organ systems and preferred terms using the Medical Dictionary for Regulatory Activities; this analysis counted only the population AE incidence by dose group, and did not track AE changes over time in individual patients. The incidence of AEs in subjects who administered 1 MAP0004 dose/month were compared with those who received 2 or ≥3 MAP0004 doses/month.
RESULTS: 288 subjects received ≥1 MAP0004 doses/month for 12 months. 77 subjects received 1 dose/month, 121 received 2 doses/month, and 90 received 3-6 doses/month of MAP0004. The incidence of AEs was similar across the 3 groups. The most common AEs were upper respiratory infections, with similar incidence across the 3 groups. Potential DHE-related AEs (eg, nausea, gastrointestinal symptoms, fatigue, chest symptoms) were comparable across all 3 groups. Incidence of individual AEs showed that most were comparable across groups, and none of the AEs were observed in clinically significant higher frequency with repeated use of MAP0004.
CONCLUSIONS: In this post-hoc analysis, repeated administration of up to 6 MAP0004 doses/month resulted in no increased incidence of drug-related AEs versus administration of 1 or 2 doses/month.
Study Supported by: Allergan, Inc.
Category - Headache: Therapeutics
Thursday, May 1, 2014 3:00 PM
P7: Poster Session VII: Headache: Treatment (3:00 PM-6:30 PM)