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Abstract Details

Onset of Action of a Zolmitriptan Microneedle System (M207, Qtrypta™) for Migraine: Comparison with Recent Early Time to Onset Recommendations, Pain Relief Results and Placebo Response
Headache
Headache Posters (7:00 AM-5:00 PM)
113

Rapid elimination of pain is a much-desired attribute in the acute treatment of migraine. Recently-proposed criteria define early onset of action for migraine treatments as  a therapeutic gain (TG [active drug minus placebo]) of ≥5% for pain freedom (PF) within 30 minutes post-dose. Administering zolmitriptan using M207, a microneedle-based system, results in rapid drug absorption. In the pivotal ZOTRIP study (N = 365), M207 3.8 mg resulted in a 27% TG for pain freedom at 2 hours.

To determine if M207 meets newly proposed criteria for early time-to-onset

We retrospectively evaluated data from ZOTRIP to determine TG at various timepoints post-treatment. We also determined the proportion of participants with PF or pain relief (PR) at 30 minutes who also had PF at 2 hours.

At 30 minutes, 45 minutes, and 60 minutes post-dose, placebo responses for PF were 3%, 5%, and 10%, respectively. Corresponding TGs were 5%, 12%, and 16%. Placebo responses for pain relief (PR) were 34%, 46%, and 53%, and TGs were 13%, 11%, and 15%.

All 6 participants who applied M207 and reported PF at 30 minutes were PF at 2 hours (83% were both PF and MBS free).  Two placebo participants reported PF at 30 minutes; 1 was PF at 2 hours. Among 38 M207-treated participants with PR at 30 minutes, 74% were PF at 2 hours (71% were both PF and MBS free). Nine of 26 (35%) placebo participants who reported PR at 30 minutes were PF at 2 hours.

M207 met the TG criteria for “early time-to-onset” in the ZOTRIP trial.  PF at 30 minutes was always associated with PF at 2 hours in the M207 group; PR at 30 minutes was associated with 2 hour PF in the majority in M207 mg group, but not the placebo group.

Authors/Disclosures
Deborah I. Friedman, MD, MPH, FAAN
PRESENTER
Dr. Friedman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Friedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Friedman has received personal compensation in the range of $0-$499 for serving as a Consultant for Satsuma. Dr. Friedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Friedman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Friedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome. Dr. Friedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Friedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Impel. Dr. Friedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Friedman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Reviews. Dr. Friedman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MedLink Neurology . The institution of Dr. Friedman has received research support from Spinal CSF Leak Foundation. Dr. Friedman has a non-compensated relationship as a Program Co-Chair, Scottsdale Headache Symposium with American Headache Society that is relevant to AAN interests or activities. Dr. Friedman has a non-compensated relationship as a Medical Advisor with Spinal CSF Leak Foundation that is relevant to AAN interests or activities. Dr. Friedman has a non-compensated relationship as a Treasurer, Board of Directors with Southern Headache Society that is relevant to AAN interests or activities.
Egilius L H Spierings, MD,PhD (MEDVADIS RESEARCH) Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Manistee. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Jean Engels (Zosano Pharma) Jean Engels has received personal compensation for serving as an employee of Zosano Pharma. Jean Engels has received stock or an ownership interest from Zosano Pharma.
Donald Kellerman (Zosano) No disclosure on file
Stewart J. Tepper, MD (The New England Institute for Neurology and Headache) Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aruene. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Atheneum. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Becker Pharmaceutical Consulting. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cleaview Healhcare Partners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CoolTech. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CRG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Decision Resources. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Defined Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DRG. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ExpertConnect. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FCB Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fenix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GLG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Advances. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Science Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HMP Communications. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Impel. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for InteractiveForums. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Keyquest. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Krog and Partners. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Magnolia Innovation. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MJH Holdings. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurolief. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for P Value Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pain Insights Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Palion Medical. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pulmatrix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Putnam Associates. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SAI MedPartners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Slingshot Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spherix Global Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Strategy Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for System Medical Comm. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Taylor and Francis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Trinity Partners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UnityHA. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for XOC. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Click Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Miravo. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurofront Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rehaler. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communications. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alphasights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Perfood. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Scilex. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communication. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tegus. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ClickTherapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CoolTech. Dr. Tepper 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. Tepper 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. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Miravo Healthcare. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pulmatrix. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Pfizer. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Scilex. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with Diamond Headache Clinic. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical Learning Institute Peerview. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical Education Speakers Network. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with Miller Medical Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Physicians' Education Resource. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with WebMD/Medscape. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with American Headache Society. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with Vindico Medical Education. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with HMP Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CMe speaker with Medical Learning Institute Peerview.