Abstract Details

Title Milk and Plasma Pharmacokinetics of Single-Dose Atogepant in Healthy Lactating Women

Topic Headache

Presentation(s) P9 - Poster Session 9 (11:45 AM-12:45 PM)

Poster/Presentation
Number 12-001

Objective To evaluate milk and plasma pharmacokinetics (PK) and relative infant dose (RID) of atogepant following single-dose administration to healthy lactating women.

Background Atogepant is an orally active CGRP receptor antagonist approved for the prophylaxis of migraine in adults.

Design/Methods In a Phase 1, open-label study, 12 healthy lactating women, one to six months post-partum, were administered 60mg single dose atogepant. Milk and plasma samples were collected for 24 hours, atogepant concentrations determined using LC-MS/MS, and PK parameters calculated. The safety and tolerability of atogepant were evaluated by assessing adverse events, physical examinations, 12-lead ECGs, laboratory tests (hematology, serum chemistry, and urinalysis), and vital sign measurements.

Results Atogepant milk concentrations were much lower than plasma concentrations and were below the LLOQ beyond 16 hours in the majority participants. The average milk:plasma concentration ratio was 0.076, and the RID was 0.188%. Mean cumulative amount of atogepant excreted in breast milk after a 60 mg dose was 0.015 mg, representing the actual infant dose should the infant drink all the milk produced. There were 2 mild adverse events, one abdominal pain upper and one dyspepsia, and no serious adverse events, clinically relevant changes in clinical labs, vital signs, or ECGs.

Conclusions Atogepant average milk:plasma concentration ratio was 0.076 following a 60mg dose in lactating women. Based on lack of atogepant accumulation upon daily dosing, the low cumulative amount of atogepant excreted in breast milk and the low RID of 0.188%, atogepant may be considered, for the preventive treatment of migraine in lactating women.

Authors/Disclosures
Ramesh R. Boinpally (Abbvie) PRESENTER	Dr. Boinpally has received personal compensation for serving as an employee of Abbvie. Dr. Boinpally has stock in Abbvie. Dr. Boinpally has received intellectual property interests from a discovery or technology relating to health care.
Jonathan H. Smith, MD (AbbVie)	Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.
Rosa De Abreu Ferreira	Rosa De Abreu Ferreira has nothing to disclose.
Joel M. Trugman, MD, FAAN	Dr. Trugman has received personal compensation for serving as an employee of AbbVie. Dr. Trugman has stock in AbbVie.

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