A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine

• Published in: Journal of headache and pain Vol. 18; no. 1; pp. 31 - 8
• Main Authors: Munjal, Sagar, Brand-Schieber, Elimor, Allenby, Kent, Spierings, Egilius L.H., Cady, Roger K., Rapoport, Alan M.
• Format: Journal Article
• Language: English
• Published: Milan Springer Milan 01.12.2017; Springer Nature B.V
• Subjects: Administration, Intranasal; Adult; Drug Combinations; Drug therapy; Female; Humans; Internal Medicine; Male; Maltose - administration & dosage; Maltose - adverse effects; Maltose - analogs & derivatives; Maltose - pharmacology; Medicine; Medicine & Public Health; Middle Aged; Migraine; Migraine Disorders - drug therapy; Nasal Sprays; Neurology; Pain Medicine; Research Article; Safety; Studies; Sumatriptan - administration & dosage; Sumatriptan - adverse effects; Sumatriptan - pharmacology; Treatment Outcome; Vasoconstrictor Agents - administration & dosage; Vasoconstrictor Agents - adverse effects; Vasoconstrictor Agents - pharmacology; Young Adult; Acute treatment; Intranasal sumatriptan; Long-term safety; Episodic migraine; DDM; Sumatriptan

Background DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and a permeation-enhancing excipient comprised of 0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM). This composition of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation and exhibit pharm...