Publications
Migraine Manuscripts
- Shrewsbury, S., Kori, S., Miller, D., Pedinoff, A. and Weinstein, S. "Randomized, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of MAP0004 (orally-inhaled DHE) in adult asthmatics" Curr Med Res Opin 2008; 24(7):1977-1985.
- Shrewsbury, S., Cook, R., Taylor, G., Edwards, C., Ramadan, N. "Safety and Pharmacokinetics of Dihydroergotamine Mesylate Administered Via a Novel (TEMPO®) Inhaler" Headache 2008, 48:355-367.
- Shrewsbury, S.B., Stonerook, M., Okikawa, J. K. "Intrapulmonary and intravenous administrations of DHE have similar CV effects in the conscious dog" Br J Pharmacol. PMID - 18289809 2008 May 26; 154(6):1254-1265.
Migraine Presentations
- A Long-Term Open-Label Study Assessing the Safety and Tolerability of LEVADEX® Orally Inhaled Dihydroergotamine in Adult Migraineurs [482KB]
As presented at the 15th Congress of the International Headache Society (IHC), June 2011 - A Thorough QT Study Comparing Supratherapeutic Dose of Orally Inhaled DHE, Moxifloxacin, and Placebo on the QT Interval in Healthy Volunteers [464KB]
As presented at the 15th Congress of the International Headache Society (IHC), June 2011 - A Drug Interaction Study Assessing the Effects of CYP3A4 Inhibition on the Pharmacokinetics of LEVADEX® (MAP0004, Orally Inhaled DHE) in Healthy Volunteers [492KB]
As presented at the 15th Congress of the International Headache Society (IHC), June 2011 - Assessment of the Consistency of Pharmacokinetic Parameters of LEVADEX® (MAP0004, Orally Inhaled DHE) in Healthy Volunteers - Results from 3 Clinical Studies [368KB]
As presented at the 15th Congress of the International Headache Society (IHC), June 2011 - Nausea Associated with Dihydroergotamine (DHE) Is a Function of Maximum Concentration and Not Route of Administration [205KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - A Long-Term, Open-Label Study Assessing the Safety and Tolerability of LEVADEX® Orally Inhaled Dihydroergotamine in Adult Migraineurs [525KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - Assessment of Cardiac Safety of LEVADEX® Orally Inhaled Dihydroergotamine (DHE) [436KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - A Thorough QT Study Comparing Supratherapeutic Dose of MAP0004 (Orally Inhaled DHE, 3.0 mg nominal dose), Moxifloxacin (400 mg), and Placebo on the QT Interval in Healthy Volunteers [487KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - A Drug Interaction Study Assessing the Effects of CYP3A4 Inhibition on the Pharmacokinetics of LEVADEX® (MAP0004, orally inhaled DHE) in Healthy Volunteers [524KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - Assessment of the Consistency of Pharmacokinetic Parameters of LEVADEX® (MAP0004, orally inhaled DHE) in Healthy Volunteers - Results from Three Clinical Studies [392KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - An Open-Label, Two-Period Crossover Study Comparing the Pharmacokinetics and Tolerability of LEVADEX® (MAP0004, orally inhaled DHE) and Intravenous DHE (DHE45®) in Smoking and Non-Smoking Adult Volunteers [416KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - A Randomized, Double-Blind, Placebo-Controlled, Three-Period Crossover Study Comparing the Acute Effects of LEVADEX® (MAP0004, orally inhaled DHE) and Intravenous DHE on Pulmonary Arterial Systolic Pressure [633KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - Migraine Recurrence Rates: Case for Standardizing the Definition [421KB]
As presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011 - Observational Study of the Appropriate Use of the MAP0004 Inhaler and Comprehension of the Accompanying Instructions for Use [628KB]
As presented at Respiratory Drug Delivery Europe 2011 (RDD), May 2011 - Utility of LEVADEX™ in Situations Where Early Intervention Paradigm is Impractical [184KB]
As presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN), April 2011 - The Major Metabolite of Dihydroergotamine (DHE) after Oral Inhalation and IV Administration Does Not Significantly Contribute to the Pharmacologic Activity [431KB]
As presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN), April 2011 - The Efficacy and Tolerability of LEVADEX™ (Orally Inhaled DHE) for the Treatment of Migraine in Subjects with Concomitant Asthma - A Subgroup Analysis [261KB]
As presented at the 52nd Annual Scientific Meeting of the American Headache Society (AHS), June 2010 - Evaluation of Safety and Efficacy of MAP0004 in Treating Acute Menstrual Migraine [348KB]
As presented at the American Academy of Neurology (AAN) 62nd Annual Meeting, April 2010 - Evaluation of Efficacy and Safety of LEVADEX™ in Treating Migraine with and without Allodynia and Reversing Allodynia, a Marker of Central Sensitization [161KB]
As presented at the American Academy of Neurology (AAN) 62nd Annual Meeting, April 2010 - The Timing of Gastric Stasis in an Acute Migraine Attack and its Impact on Treatment [102KB]
As presented at the American Academy of Neurology (AAN) 62nd Annual Meeting, April 2010 - Efficacy and tolerability of MAP0004, a novel inhaled therapy, in treating acute migraine [2.2MB]
As presented at the 14th Congress of the International Headache Society, September 2009 - Efficacy evaluation of LEVADEX™ (previously MAP0004) in treating resistant migraine including migraine with allodynia, migraine treated late in its cycle, morning migraine and disabling migraine [695KB]
As presented at the 14th Congress of the International Headache Society, September 2009 - Efficacy evaluation of LEVADEX™ (previously MAP0004) in treating a broad spectrum of acute migraine attacks including patients using triptans and patients not using triptans [2.1MB]
As presented at the 14th Congress of the International Headache Society, September 2009 - Efficacy and Tolerability of MAP0004, Featuring a Novel Delivery System, In Treating Acute Migraine [105KB]
As presented at the European Headache and Migraine Trust International Congress (EHMTIC), September 2008 - Precise Pulmonary Delivery of Dihydroergotamine and Mechanism for Reduced Adverse Effect Profile [246KB]
As presented at the European Headache and Migraine Trust International Congress (EHMTIC), September 2008 - Sustained Pain Relief in Migraine is Not Necessarily Dependent on the PK of a Drug and Does Not Have to be at the Cost of Rapid Onset of Relief [74KB]
As presented at the European Headache and Migraine Trust International Congress (EHMTIC), September 2008 - MAP0004, an Orally Inhaled Formulation of DHE, Delivers Faster and More Consistent Blood Levels of the Drug Compared to Traditional Oral, Subcutaneous, Intramuscular, and Intranasal Formulations of DHE [88KB]
As presented at the American Headache Society (AHS) 50th Annual Headache Symposium, June 2008 - Pharmacological Profiling of Dihydroergotamine and its Relevance to Systemic Delivery via the Respiratory Tract [142KB]
As presented at the American Headache Society (AHS) 50th Annual Headache Symposium, June 2008 - Newer Acute Migraine Specific Drugs May Provide Improved Sustained Relief and Freedom over 24 and 48 Hours Post Dosing [68KB]
As presented at the American Headache Society (AHS) 50th Annual Headache Symposium, June 2008 - Systemic Pharmacokinetics of DHE When Delivered Via the Lung to Asthmatics by the Tempo® Inhaler [108KB]
As presented at the American Headache Society (AHS) 50th Annual Headache Symposium, June 2008 - Assessment of QTc Effect of DHE When Delivered Via the Lung by the Tempo® Inhaler [79KB]
As presented at the American Headache Society (AHS) 50th Annual Headache Symposium, June 2008 - Chronic Inhalation Toxicity Assessment of Dihydroergotamine in Dogs [142KB]
As presented at the American Headache Society (AHS) 50th Annual Headache Symposium, June 2008 - Dihydroergotamine Mesylate Monohydrate Solid State Characterization for Inhalation Formulation: Polymorph Screening and Determination of Amorphous Content [362KB]
As presented at the Respiratory Drug Delivery Conference (RDD), May 2008 - Precision Dosing of Dihydroergotamine (DHE) by Inhalation [603KB PDF]
As presented at the 13th Congress of the International Headache Society, June 2007 - Rapid and Sustained Clinical Efficacy and Safety of Inhaled Dihydroergotamine Mesylate via a Novel Inhaler (Tempo® Inhaler) [1067KB PDF]
As presented at the American Headache Society (AHS) 49th Annual Headache Symposium, June 2007 - Clinical Safety of Inhaled Dihydroergotamine Mesylate via a Novel System (Tempo® Inhaler) [3746KB PDF]
As presented at the American Headache Society (AHS) 49th Annual Headache Symposium, June 2007 - Comparative Clinical Pharmacokinetics of Parent Drug and Metabolites Following Inhaled Dosing with Dihydroergotamine Mesylate via a Novel System (Tempo® Inhaler) [3937KB PDF]
As presented at the American Headache Society (AHS) 49th Annual Headache Symposium, June 2007 - Delivery Performance of Dihydroergotamine Mesylate (DHE) Using the Breath Synchronized, Plume Controlled Tempo® Inhaler [455KB PDF]
As presented at the Respiratory Drug Delivery (RDD X) Conference, April 2006 - Intra-pulmonary Artery as Compared to Peripheral Venous Dosing of Dihydroergotamine (DHE) in Telemeterized, Awake Dogs [219KB PDF]
As presented at the American Academy of Neurology (AAN) 58th Annual Meeting, April 2006