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      STOP 301: A Phase 3, open‐label study of safety, tolerability, and exploratory efficacy of INP104, Precision Olfactory Delivery (POD ®) of dihydroergotamine mesylate, over 24/52 weeks in acute treatment of migraine attacks in adult patients

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          Abstract

          Objective

          To report the safety, tolerability, exploratory efficacy, and patient acceptability of INP104 for the acute treatment of migraine from the Phase 3 STOP 301 trial.

          Background

          Dihydroergotamine (DHE) has long been used to treat migraine, but intravenous administration is invasive, frequently associated with adverse events (AEs), and not suitable for at‐home administration. INP104 is an investigational drug device that delivers DHE mesylate to the upper nasal space using a Precision Olfactory Delivery technology and was developed to overcome the shortcomings of available DHE products.

          Methods

          STOP 301 was an open‐label, 24‐week safety study, with a 28‐week extension period. After a 28‐day screening period where patients used their “best usual care” to treat migraine attacks, patients were given INP104 (1.45 mg) to self‐administer nasally with self‐recognized attacks. The primary objective of this study was to assess safety and tolerability, with a specific focus on nasal mucosa and olfactory function. Exploratory objectives included efficacy assessments of migraine measures and a patient acceptability questionnaire.

          Results

          A total of 360 patients entered the 24‐week treatment period, with 354 patients dosing at least once. INP104‐related treatment‐emergent AEs were reported by 36.7% (130/354) of patients, and 6.8% (24/354) discontinued treatment due to AEs over 24 weeks. No new safety signals were observed following delivery to the upper nasal space. Pain freedom, the most bothersome symptom freedom, and pain relief at 2 h post‐INP104 were self‐reported by 38.0% (126/332), 52.1% (173/332), and 66.3% (167/252) of patients, respectively. A low recurrence rate at 24 and 48 h was observed (7.1% [9/126] and 14.3% [18/126], respectively). Most patients found INP104 easy to use and preferred it over their current therapy.

          Conclusions

          INP104 has the potential to deliver rapid symptom relief, without injection, that is well tolerated and suitable for outpatient use. Results suggest INP104 may be a promising treatment for patients with migraine.

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          Most cited references49

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          Prevalence and Burden of Migraine in the United States: Data From the American Migraine Study II

          To describe the prevalence, sociodemographic profile, and the burden of migraine in the United States in 1999 and to compare results with the original American Migraine Study, a 1989 population-based study employing identical methods.
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            The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies.

            The study aims to provide an updated assessment of the evidence for individual pharmacological therapies for acute migraine treatment. Pharmacological therapy is frequently required for acutely treating migraine attacks. The American Academy of Neurology Guidelines published in 2000 summarized the available evidence relating to the efficacy of acute migraine medications. This review, conducted by the members of the Guidelines Section of the American Headache Society, is an updated assessment of evidence for the migraine acute medications. A standardized literature search was performed to identify articles related to acute migraine treatment that were published between 1998 and 2013. The American Academy of Neurology Guidelines Development procedures were followed. Two authors reviewed each abstract resulting from the search and determined whether the full manuscript qualified for review. Two reviewers studied each qualifying full manuscript for its level of evidence. Level A evidence requires at least 2 Class I studies, and Level B evidence requires 1 Class I or 2 Class II studies. The specific medications - triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan [oral, nasal spray, injectable, transcutaneous patch], zolmitriptan [oral and nasal spray]) and dihydroergotamine (nasal spray, inhaler) are effective (Level A). Ergotamine and other forms of dihydroergotamine are probably effective (Level B). Effective nonspecific medications include acetaminophen, nonsteroidal anti-inflammatory drugs (aspirin, diclofenac, ibuprofen, and naproxen), opioids (butorphanol nasal spray), sumatriptan/naproxen, and the combination of acetaminophen/aspirin/caffeine (Level A). Ketoprofen, intravenous and intramuscular ketorolac, flurbiprofen, intravenous magnesium (in migraine with aura), and the combination of isometheptene compounds, codeine/acetaminophen and tramadol/acetaminophen are probably effective (Level B). The antiemetics prochlorperazine, droperidol, chlorpromazine, and metoclopramide are probably effective (Level B). There is inadequate evidence for butalbital and butalbital combinations, phenazone, intravenous tramadol, methadone, butorphanol or meperidine injections, intranasal lidocaine, and corticosteroids, including dexamethasone (Level C). Octreotide is probably not effective (Level B). There is inadequate evidence to refute the efficacy of ketorolac nasal spray, intravenous acetaminophen, chlorpromazine injection, and intravenous granisetron (Level C). There are many acute migraine treatments for which evidence supports efficacy. Clinicians must consider medication efficacy, potential side effects, and potential medication-related adverse events when prescribing acute medications for migraine. Although opioids, such as butorphanol, codeine/acetaminophen, and tramadol/acetaminophen, are probably effective, they are not recommended for regular use.
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              University of Pennsylvania Smell Identification Test: a rapid quantitative olfactory function test for the clinic.

              Despite the fact that clinical otolaryngologists are often presented with complaints of olfactory dysfunction, they have limited means to diagnose these problems. A major reason has been the lack of a clinically-useful and reliable quantitative test of olfactory function. Recent work at our Clinical Research Center has resulted in the development of such a test. This test--the University of Pennsylvania Smell Identification Test (UPSIT)--can be self-administered and uses microencapsulated odorants which are released by scratching standardized odor-impregnated test booklets. As indicated in this paper, studies have demonstrated that the UPSIT can identify most malingerers and is sensitive to age, gender, smoking habits, and a wide variety of olfactory disorders. A description of this new test, along with some of its applications, is presented.
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                Author and article information

                Contributors
                saurora@impelnp.com
                Journal
                Headache
                Headache
                10.1111/(ISSN)1526-4610
                HEAD
                Headache
                John Wiley and Sons Inc. (Hoboken )
                0017-8748
                1526-4610
                07 August 2021
                September 2021
                : 61
                : 8 ( doiID: 10.1111/head.v61.8 )
                : 1214-1226
                Affiliations
                [ 1 ] Department of Research StudyMetrix Research St. Peters MO USA
                [ 2 ] Palm Beach Headache Center West Palm Beach FL USA
                [ 3 ] Medical Affairs Impel NeuroPharma Seattle WA USA
                Author notes
                [*] [* ] Correspondence

                Sheena K. Aurora, Impel NeuroPharma, 201 Elliott Avenue West, Suite 260, Seattle, WA 98119, USA.

                Email: saurora@ 123456impelnp.com

                Article
                HEAD14184
                10.1111/head.14184
                9292844
                34363701
                85dd02d9-a251-4620-9e0a-b695d736271c
                © 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                Page count
                Figures: 6, Tables: 3, Pages: 13, Words: 8620
                Product
                Funding
                Funded by: Impel NeuroPharma
                Categories
                Research Submissions
                Research Submissions
                Custom metadata
                2.0
                September 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:18.07.2022

                dihydroergotamine,efficacy,migraine,precision olfactory delivery,safety/tolerability,upper nasal space

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