Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study

Sagar Munjal, Alix Bennett Promius Pharma, Princeton, NJ, USA Background: The objective of this proof-of-concept study was to assess the safety, efficacy, and potential for dose response of a new oral liquid formulation of celecoxib, DFN-15, in adults with migraine. Variability in patient-identifi...

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Autores principales:	Munjal S, Bennett A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Episodic migraine acute treatment efficacy safety celecoxib Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/70f2c652911a4bf585949cbdd4bd9334
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spelling	oai:doaj.org-article:70f2c652911a4bf585949cbdd4bd93342021-12-02T07:28:51ZEfficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study1178-2021https://doaj.org/article/70f2c652911a4bf585949cbdd4bd93342017-11-01T00:00:00Zhttps://www.dovepress.com/efficacy-and-safety-of-dfn-15-an-oral-liquid-formulation-of-celecoxib--peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Sagar Munjal, Alix Bennett Promius Pharma, Princeton, NJ, USA Background: The objective of this proof-of-concept study was to assess the safety, efficacy, and potential for dose response of a new oral liquid formulation of celecoxib, DFN-15, in adults with migraine. Variability in patient-identified most bothersome symptom (MBS) across 3 migraine attacks was also evaluated. Methods: This was a randomized, placebo-controlled, double-blind, 3-treatment, 6-sequence, 3-period, crossover study of 3 treatments (DFN-15 120 mg, DFN-15 240 mg, and placebo) administered at the onset of moderate to severe headache. Results: Of 63 randomized subjects, 56 (89%) took single doses of DFN-15 120 mg and 240 mg and completed all 3 treatment periods. Most subjects were female (75.0%) and white (86.7%), with a mean age of 43.6 years. Both doses of DFN-15 achieved a higher 2-hour pain-free response than placebo (29.1% for 120 mg, 26.1% for 240 mg, and 17.6% for placebo), but the differences were not statistically significant. Photophobia was most commonly reported as the MBS, but for 53% of subjects (27/51), their identified MBS varied across the 3 studied attacks. The most common treatment-emergent adverse events with DFN-15 were dysgeusia (≤11.8%) and nausea (≤5.9%). Conclusion: Both doses of DFN-15 outperformed placebo for the 2-hour pain-free end point, but due to a carryover effect with placebo, the differences were not statistically significant. Since response to both doses was similar, DFN-15 120 mg is being further developed for the management of acute migraine. Further study is needed to determine whether the current findings are altered by larger or different trial designs (ClinicalTrials.gov identifier: NCT02472418). Keywords: episodic migraine, acute treatment, efficacy, safety, celecoxib Munjal SBennett ADove Medical PressarticleEpisodic migraineacute treatmentefficacysafetycelecoxibNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 2797-2802 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Episodic migraine acute treatment efficacy safety celecoxib Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Episodic migraine acute treatment efficacy safety celecoxib Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Munjal S Bennett A Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study
description	Sagar Munjal, Alix Bennett Promius Pharma, Princeton, NJ, USA Background: The objective of this proof-of-concept study was to assess the safety, efficacy, and potential for dose response of a new oral liquid formulation of celecoxib, DFN-15, in adults with migraine. Variability in patient-identified most bothersome symptom (MBS) across 3 migraine attacks was also evaluated. Methods: This was a randomized, placebo-controlled, double-blind, 3-treatment, 6-sequence, 3-period, crossover study of 3 treatments (DFN-15 120 mg, DFN-15 240 mg, and placebo) administered at the onset of moderate to severe headache. Results: Of 63 randomized subjects, 56 (89%) took single doses of DFN-15 120 mg and 240 mg and completed all 3 treatment periods. Most subjects were female (75.0%) and white (86.7%), with a mean age of 43.6 years. Both doses of DFN-15 achieved a higher 2-hour pain-free response than placebo (29.1% for 120 mg, 26.1% for 240 mg, and 17.6% for placebo), but the differences were not statistically significant. Photophobia was most commonly reported as the MBS, but for 53% of subjects (27/51), their identified MBS varied across the 3 studied attacks. The most common treatment-emergent adverse events with DFN-15 were dysgeusia (≤11.8%) and nausea (≤5.9%). Conclusion: Both doses of DFN-15 outperformed placebo for the 2-hour pain-free end point, but due to a carryover effect with placebo, the differences were not statistically significant. Since response to both doses was similar, DFN-15 120 mg is being further developed for the management of acute migraine. Further study is needed to determine whether the current findings are altered by larger or different trial designs (ClinicalTrials.gov identifier: NCT02472418). Keywords: episodic migraine, acute treatment, efficacy, safety, celecoxib
format	article
author	Munjal S Bennett A
author_facet	Munjal S Bennett A
author_sort	Munjal S
title	Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study
title_short	Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study
title_full	Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study
title_fullStr	Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study
title_full_unstemmed	Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study
title_sort	efficacy and safety of dfn-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/70f2c652911a4bf585949cbdd4bd9334
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Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study

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