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Abstract Details

Pharmacokinetics, Safety, and Tolerability of Ubrogepant for the Acute Treatment of Migraine Following Coadministration With Preventive Monoclonal Antibody Treatment
Headache
Headache Posters (7:00 AM-5:00 PM)
010

Ubrogepant, an approved acute treatment for migraine in adults, is used to treat breakthrough attacks in patients receiving preventive treatment.

To examine pharmacokinetics (PK), safety, and tolerability of ubrogepant following coadministration with monoclonal antibody (mAb) preventive treatments, erenumab or galcanezumab.

This open-label, multicenter trial enrolled adults diagnosed for ≥1 year with migraine not on preventive treatment. Participants were assigned to an erenumab arm or galcanezumab arm. In each arm, participants received ubrogepant 100mg on day 1 (without a mAb). On day 8, participants received the assigned mAb: single subcutaneous (SC) erenumab 140mg injection or galcanezumab 240mg (2 SC 120mg injections). Ubrogepant 100mg was administered once daily on days 12–15. PK parameters of ubrogepant were assessed on days 1 and 12. Participants were followed for 30 days. 

Forty participants enrolled (20 per arm). Ubrogepant peak plasma concentration (Cmax), area under the concentration-time curve from time 0 to t (AUC0-t), and to infinity (AUC0-∞) were minimally elevated after erenumab administration. With/without erenumab, median ubrogepant time to Cmax (tmax) was 1.5 h; apparent terminal half-life (t1/2) was similar with (5.3 h) and without (4.6 h) erenumab. With galcanezumab coadministration, ubrogepant Cmax was unchanged while AUC0-t and AUC0-∞ were 5% higher. Ubrogepant tmax was 1.5 h; t1/2 was similar with (5.0 h) and without (4.6 h) galcanezumab. No serious adverse events (AEs) or AEs leading to discontinuation were reported. In the erenumab arm, treatment-emergent AEs (TEAEs) were reported by 7/20 participants receiving ubrogepant alone, 8/19 with erenumab, and 7/19 with ubrogepant+erenumab. In the galcanezumab arm, TEAEs were reported by 2/20 participants receiving ubrogepant alone, 3/20 with galcanezumab, and 4/19 with ubrogepant+galcanezumab. No clinically relevant changes in laboratory parameters, vital signs, or electrocardiogram values were observed.

Ubrogepant PK was unchanged when coadministered with erenumab or galcanezumab. No safety concerns were identified.

Authors/Disclosures
Janette Contreras-De Lama
PRESENTER
Janette Contreras-De Lama has received personal compensation for serving as an employee of AbbVie. Janette Contreras-De Lama has stock in AbbVie.
Abhijeet Jakate, PhD (Allergan Plc) No disclosure on file
Andrew M. Blumenfeld, MD, FAAN (The Los Angeles Headache Center) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck.
Ramesh *use 388303 Boinpally Ramesh Boinpally has received personal compensation for serving as an employee of Allergan/Abbvie. Ramesh Boinpally has stock in Abbvie. Ramesh Boinpally has stock in Allergan. Ramesh Boinpally has received intellectual property interests from a discovery or technology relating to health care.
Matthew Butler Matthew Butler has received personal compensation for serving as an employee of Allergan / Abbvie. Matthew Butler has received stock or an ownership interest from Allergan/Abbvie.
Lisa Borbridge (AbbVie) Lisa Borbridge has received personal compensation for serving as an employee of AbbVie. Lisa Borbridge has received stock or an ownership interest from AbbVie.
Danielle McGeeney Danielle McGeeney has received personal compensation for serving as an employee of AbbVie. Danielle McGeeney has received stock or an ownership interest from AbbVie.
Antonia Periclou Antonia Periclou has received personal compensation for serving as an employee of Allergan/AbbVie. Antonia Periclou has received stock or an ownership interest from Allergan/AbbVie.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine) Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has stock in Biohaven. Dr. Lipton has stock in Manistee. Dr. Lipton has stock in Axon. Dr. Lipton has stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.