Abstract Details

Title Rimegepant 75 mg Exposure, Safety, and Tolerability are Similar in Elderly and Nonelderly Adults: a Phase 1, Open-Label, Parallel-Group, Single-Dose Study

Topic Headache

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)

Poster/Presentation
Number 7-012

Objective The objective of this study was to evaluate the pharmacokinetics (PK), safety, and tolerability of rimegepant in elderly and nonelderly adults.

Background Treatment of elderly persons with migraine can be challenging due to comorbid conditions and a greater probability of adverse events (AEs). Rimegepant is an orally administered small molecule CGRP receptor antagonist with demonstrated efficacy and safety in the acute treatment of migraine. The effects of age on its PK, safety, and tolerability have not been assessed.

Design/Methods This was a single center, Phase 1, open-label, 2-group, single-dose, parallel PK study in elderly and nonelderly healthy volunteers. Elderly subjects with stable chronic illness (same medication for ≥3 months; no dosage change within 14 days predose) were eligible. Adult nonsmokers aged ≥18 and ≤45 years (non-elderly) or ≥65 years of age (elderly), with BMI ≥18.5 and ≤30.0 kg/m2; weight ≥50.0 kg (males) and ≥45.0 kg (females); and a score of 0 on the Sheehan Suicidality Tracking Scale (S-STS) were given a single 75 mg oral dose of rimegepant on Day 1 under fasting conditions.

Results Of the 42 subjects enrolled, 28 were treated, completed the study, and analyzed for safety and PK (14 elderly, 14 non-elderly). Compared with nonelderly subjects, elderly subjects had small (<5%) increases in AUC and decreases in Cmax. No adverse events (AEs) were serious or led to discontinuation. Eight (28.6%) subjects (4 elderly, 4 non-elderly) experienced at least 1 treatment-emergent AE (TEAE). The only event TEAE reported in >1 subject was headache, which was reported in 2 (7.1%) subjects (1 elderly, 1 non-elderly). All TEAEs were mild; no clinically meaningful changes from baseline in laboratory values, vital signs, ECGs, or the S-STS were identified.

Conclusions Exposure, safety, and tolerability following a single oral 75 mg dose of rimegepant was similar in elderly and nonelderly subjects.

Authors/Disclosures
PRESENTER	No disclosure on file
	No disclosure on file
Vladimir Coric	Vladimir Coric has received personal compensation for serving as an employee of Biohaven. Vladimir Coric has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Bioahven. Vladimir Coric has stock in Biohaven. Vladimir Coric has received intellectual property interests from a discovery or technology relating to health care.
Robert Croop, MD	Dr. Croop has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc. Dr. Croop has received personal compensation for serving as an employee of Pfizer Inc.. Dr. Croop has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Collima LLC. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has stock in Biohaven Ltd.. Dr. Croop has stock in Actio Biosciences, Inc. . Dr. Croop has received research support from Pfizer Inc. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.