Abstract Details

Title Rescue Medication Use during MAP0004 Phase 3 Trial

Topic Headache

Presentation(s) P01 - (-)

Poster/Presentation
Number 087

Objective

Background Relief of pain can be measured by several endpoints, including sustained pain relief, recurrence and the extent of rescue medication use. Migraine patients use rescue medication when symptoms persist or recur after initial treatment. Rescue medication use is a good indication of the extent of relief provided by initial treatment. MAP0004 is an investigational product candidate that consists of dihydroergotamine (DHE) delivered via a TEMPO® breath-actuated inhaler. MAP0004 was effective in the acute treatment of migraine in a Phase 3 trial.

Design/Methods Subjects were instructed to refrain from taking rescue medications for at least 2 hr after study treatment administration. Subjects who did not respond to study treatment and subjects who had initial relief followed by pain recurrence were allowed to take rescue medication 2 hrs after study treatment administration. An electronic diary was used to collect rescue medication use information.

Results This post-hoc analysis included 794 patients randomized (1:1) to receive double-blind treatment with MAP0004 or placebo. Rescue medication use in the double-blind period was consistently lower with MAP0004 than with placebo at 2 hr (4% vs 8%, P=0.0261), 4 hr (19% vs 37%, P<0.0001), 24 hr (36% vs 54%, P<0.0001), and 48 hr (42% vs 59%, P<0.0001) after study-drug administration. Among patients who reported pain relief at 2 hr, MAP0004 patients had significantly lower rescue medication use at 4, 24, and 48 hr as compared to placebo-treated patients. No drug-related serious adverse events were reported.

Conclusions In this post-hoc analysis of the double-blind period of a Phase 3 trial, rescue medication use was significantly lower with MAP0004 recipients as compared to placebo.

Authors/Disclosures
Donald Kellerman (Zosano) PRESENTER	No disclosure on file
	No disclosure on file
Shashidhar Kori, MD	Dr. Kori has received personal compensation for serving as an employee of Novilla Pharma. Dr. Kori has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Satsuma Pharma. Dr. Kori has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Tonix Pharma. Dr. Kori has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Exalys Pharma. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Consultant for NewBio Pharma. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Consultant for Afsci Pharma. Dr. Kori has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Trigemina Inc. Dr. Kori has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Novilla Pharma. Dr. Kori has received stock or an ownership interest from Novilla Pharma. Dr. Kori has received stock or an ownership interest from NewBio Pharma. Dr. Kori has received stock or an ownership interest from Tonix Pharma. Dr. Kori has received intellectual property interests from a discovery or technology relating to health care. Dr. Kori has received intellectual property interests from a discovery or technology relating to health care. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Reviewer of grant applications with Department of Defense.
Biao Lu	No disclosure on file

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