Early Onset of Efficacy and Consistency of Response Across Multiple Migraine Attacks From the Randomized COMPASS Study: AVP‐825 Breath Powered<sup>®</sup>Exhalation Delivery System (Sumatriptan Nasal Powder) vs Oral Sumatriptan

Silberstein, Stephen D.; Winner, Paul; McAllister, Peter; Tepper, Stewart J.; Halker, Rashmi B.; Mahmoud, Ramy; Siffert, João

doi:10.1111/head.13105

Cited by 21 publications

(23 citation statements)

References 24 publications

(69 reference statements)

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“…A significantly greater reduction in migraine pain intensity occurred with AVP-825 treatment vs sumatriptan oral in the 30 minutes postdose, as assessed by summed pain intensity differences (SPID-30, 10.80 vs 7.41, P <0.001, primary end point), and this was true regardless of whether attacks were treated when pain was mild or moderate/severe. 34 As early as 15 minutes postdose, rates of pain freedom (7.2% vs 3.7%, P =0.008) and pain relief (27.9% vs 20.9%, P =0.007) were significantly greater with AVP-825 vs sumatriptan oral, and significant differences in favor of AVP-825 continued through every time point up to and including 90 minutes postdose. Sustained efficacy was similar between treatments, as measured by rates of sustained pain relief and sustained pain freedom from 120 minutes up to 48 hours.…”

Section: Introductionmentioning

confidence: 91%

“…The most common AEs in all trials related to the site of administration were predominantly mild in severity, and AEs related to abnormal taste did not lead to any discontinuations. 34 There was only one case of a mild atypical sensation (paresthesia) in the single-attack Phase II and III placebo-controlled trials, and in the multiattack Phase III COMPASS trial, atypical sensations occurred at a significantly lower rate with AVP-825 vs 100 mg sumatriptan oral tablet.…”

Section: Introductionmentioning

confidence: 96%

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Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine

Tepper¹,

Johnstone²

2018

MDER

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There is a need for fast-acting, non-oral medication options for migraine because some attacks develop rapidly and some are accompanied by nausea, vomiting, and gastroparesis, which can hinder oral medication uptake and absorption. The most commonly prescribed migraine medications are oral triptans, with sumatriptan as the most common. However, oral triptans are associated with adverse events (AEs) of atypical sensations that may be problematic for patients. Subcutaneous (SC) injectable sumatriptan and conventional liquid triptan nasal spray formulations are also available, but the frequency of atypical sensations is the highest with SC sumatriptan, and the intense bitter taste of conventional liquid triptan nasal spray discourages use. AVP-825 (ONZETRA® Xsail®) is an intranasal medication delivery system containing 22 mg sumatriptan nasal powder that is now available in the USA for the acute treatment of migraine with or without aura in adults. The objective of this review is to summarize the development of AVP-825, which utilizes unique features of nasal anatomy to achieve efficient absorption and reduced systemic exposure. Literature searches for “sumatriptan nasal powder”, “AVP-825”, and “sumatriptan intranasal” were conducted. Review articles and pharmacokinetic, Phase II and Phase III studies were evaluated. AVP-825 demonstrates an earlier onset of efficacy and lower rate of atypical sensations than the oral standard of care, which can be attributed to its fast absorption and low systemic exposure. AEs of abnormal taste are predominantly mild. These results confirm the initial design concept for AVP-825, which aligned pharmacokinetics, anatomy, and drug presentation in a novel device to achieve optimal outcomes for the acute treatment of migraine.

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Section: Introductionmentioning

confidence: 91%

Section: Introductionmentioning

confidence: 96%

Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine

Tepper¹,

Johnstone²

2018

MDER

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“…Eine weitere neue und innovative nasale Applikationsform für Sumatriptan ist ONZETRA Xsail™, welches mittels Ausatemluft Sumatriptan als Pulver in den hinteren oberen Nasenabschnitt zerstäubt. Daten aus der COMPASS-Studie und einer sekundär/retrospektiven Analyse [19] dieser multizentrischen, randomisierten, doppelblinden, Doppel-Dummy-Crossover-Studie, in der 100 mg orales Sumatriptan gegen eine neue nasale Applikationsform geprüft wurde, sind positiv bezüglich des primären Endpunktes (Summe der Schmerzintensitätsdifferenzen innerhalb der ersten 30 Minuten [SPID-30]) für sowohl milde als auch für moderate bis schwere Attacken. Für die ersten 1,5 Stunden war das Pulver der Tablette in Bezug auf die "totale Migränefreiheit" überlegen.…”

Section: Applikationsform Der Triptantherapieunclassified

Kopfschmerzen – Update 2018

Diener¹,

Gaul²,

Holle-Lee³

et al. 2019

Laryngo-Rhino-Otol

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ZusammenfassungDie Kopfschmerzforschung macht Fortschritte. Dies zeigt sich an der großen Zahl von Publikationen zur Epidemiologie, Pathophysiologie, Akuttherapie und Prophylaxe von Kopfschmerzen. Die vorliegende Übersicht referiert die wichtigsten Studien zu Kopfschmerzen aus dem Zeitraum 2017 bis Juni 2018. Die Auswahl der referierten Studien ist subjektiv und erfolgte nach der Einschätzung der Autoren.

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“…Na ovaj način se povećava deo doze koja se apsorbuje preko sluzokože nosa, a smanjuje deo apsorbovan iz GIT-a, u poređenju sa sprejevima za nos. Klinička ispitivanja su ukazala da se postiže brzo ublažavanje migrenoznog bola slično supkutanoj injekciji sumatriptana (46,47). Još uvek nema dovoljno podatka o podnošljivosti na mestu primene sumatriptan praška za nos.…”

Section: Savremeni Farmaceutski Oblici Triptanaunclassified

Novel pharmaceutical dosage forms of analgesics

Djekić¹,

Primorac²

2018

Arhiv za farmaciju

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Među savremenim farmaceutskim oblicima analgetika, čiji se broj i raznovrsnost kontinuirano povećavaju tokom poslednje dve decenije, od posebnog značaja su transdermalni flasteri opioidnih analgetika (fentanil, buprenorfin) za terapiju hroničnog bola, jontoforetski transdermalni terapijski sistem fentanila za suzbijanje akutnog postoperativnog bola, kao i komprimovana lozenga, bukalna tableta i film, sublingvalna tableta i sprejevi za nos za tretman probojnog kancerskog bola fentanilom. U cilju poboljšanja efikasnosti terapije migrenoznog bola, u odnosu na čvrste farmaceutske oblike (tableta) triptana, za tretman migrenoznog bola razvijeni su i komercijalizovani farmaceutski preparati sumatriptana u obliku rastvora za supkutanu injekciju, spreja za nos i praška za nos, kao i zolmitriptan orodisperzibilna tableta i sprej za nos. Prednosti ovih farmaceutskih preparata su minimalna invazivnost i mogućnost prilagođavanja individualnim terapijskim potrebama pacijenata, u pogledu početka i dužine trajanja dejstva i isporučene doze aktivne supstance. U poslednjih nekoliko godina Evropska agencija za lekove (European Medicines Agency, EMA) i Agencija za hranu i lekove SAD (Food and Drug Administration, FDA) upozorile su na fatalne greške pri upotrebi i zloupotrebi transdermalnih flastera fentanila i ukazale na značaj edukacije zdravstvenih radnika i pacijenata o potencijalnim rizicima. Takođe, savremeni farmaceutski oblici fentanila za terapiju akutnog bola mogu se propisivati i upotrebljavati isključivo u okviru FDA programa za procenu rizika i strategije ograničavanja (Risk Evaluation and Mitigation Strategy, REMS) čiji je cilj obezbeđenje veće koristi od potencijalnih rizika. Još uvek nisu formirani precizni stavovi o značaju skoro odobrenih farmaceutskih proizvoda analgetika, a neophodne su i kliničke procene njihove relativne efikasnosti i podnošljivosti na mestu primene. Ključne reči: opioidni analgetici; triptani; transdermalni terapijski sistemi; transmukozni preparati; REMS program.

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Early Onset of Efficacy and Consistency of Response Across Multiple Migraine Attacks From the Randomized COMPASS Study: AVP‐825 Breath Powered^®Exhalation Delivery System (Sumatriptan Nasal Powder) vs Oral Sumatriptan

Cited by 21 publications

References 24 publications

Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine

Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine

Kopfschmerzen – Update 2018

Novel pharmaceutical dosage forms of analgesics

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Early Onset of Efficacy and Consistency of Response Across Multiple Migraine Attacks From the Randomized COMPASS Study: AVP‐825 Breath Powered®Exhalation Delivery System (Sumatriptan Nasal Powder) vs Oral Sumatriptan

Cited by 21 publications

References 24 publications

Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine

Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine

Kopfschmerzen – Update 2018

Novel pharmaceutical dosage forms of analgesics

Contact Info

Product

Resources

About

Early Onset of Efficacy and Consistency of Response Across Multiple Migraine Attacks From the Randomized COMPASS Study: AVP‐825 Breath Powered^®Exhalation Delivery System (Sumatriptan Nasal Powder) vs Oral Sumatriptan