Claims for Patent: 10,722,667

Summary for Patent: 10,722,667

Title:	Nasal administration
Abstract:	A delivery device for and method of delivering a powdered substance, in particular a triptan, such as sumatriptan, to the posterior region of a nasal cavity of a subject, in particular for the treatment of headaches, for example, cluster headaches and migraine, and neuropathic pain, the delivery device comprising: a nosepiece for insertion into a nasal cavity of a subject through which the powdered substance is delivered to the posterior region of the nasal cavity of the subject, in particular the upper posterior two thirds of the nasal cavity; and a substance supply unit which is operable to deliver the powdered substance through the nosepiece.
Inventor(s):	Djupesland; Per Gisle (Oslo, NO), Hafner; Roderick Peter (Swindon, GB)
Assignee:	OptiNose AS (Oslo, NO)
Application Number:	15/481,975
Patent Claims:	1. A device for delivering a powdered sumatriptan substance to a nasal cavity of a subject, comprising: a nosepiece configured to be fitted to a nostril of the subject, wherein the nosepiece is configured to extend into the nostril of the subject and expand at least a portion of a nasal valve of the subject; and a substance containing unit connected to the nosepiece, the substance containing unit containing the powdered sumatriptan substance to be delivered to the nasal cavity of the subject, the powdered sumatriptan substance comprising a particle size distribution in which at least 10% of the particles are less than about 20 .mu.m, at least 50% of the particles are less than about 50 .mu.m, at least 50% of the particles are greater than about 30 .mu.m, and at least 90% of the particles are less than about 150 .mu.m; and a trap disposed between the substance containing unit and the nosepiece; wherein the device is configured such that, when the nosepiece is fitted to the nostril of the subject, oral exhalation by the subject through the substance containing unit and the nosepiece acts to close the oropharyngeal velum of the subject and produce an exhalation flow passing into one nasal passage of the subject and out of the other nasal passage of the subject, thereby achieving a bi-directional exhalation flow for delivering the powdered sumatriptan substance to a portion of the nasal cavity of the subject. 2. The device of claim 1, wherein the powdered sumatriptan substance comprises a sumatriptan base or sumatriptan succinate. 3. The device of claim 1, wherein the powdered sumatriptan substance contains only sumatriptan succinate and no introduced excipients or adjuvants. 4. The device of claim 1, wherein the powdered sumatriptan substance to be delivered to the nasal cavity of the subject is disposed in a substance container. 5. The device of claim 4, wherein the substance container is a capsule. 6. The device of claim 4, wherein the substance container contains a 10 mg dose of the powdered sumatriptan substance. 7. The device of claim 1, wherein the powdered sumatriptan substance to be delivered to the nasal cavity of the subject is disposed in a capsule. 8. The device of claim 1, wherein the powdered sumatriptan substance has a particle size distribution in which at least 10% of the particles are less than about 10 .mu.m and at least 90% of the particles are less than about 90 .mu.m. 9. A device for delivering powdered sumatriptan substance to a nasal cavity of a subject, comprising: a mouthpiece configured to be fitted to an oral cavity of the subject; a nosepiece configured to be fitted to a nostril of the subject, wherein the nosepiece is configured to extend into the nostril of the subject and expand at least a portion of a nasal valve of the subject; a substance containing unit connected to the nosepiece, the substance containing unit containing the powdered sumatriptan substance to be delivered to the nasal cavity of the subject, the powdered sumatriptan substance comprising a particle size distribution in which at least 10% of the particles are less than about 20 .mu.m, at least 50% of the particles are less than about 50 .mu.m, at least 50% of the particles are greater than about 30 .mu.m, and at least 90% of the particles are less than about 150 .mu.m; and a trap disposed between the substance containing unit and the nosepiece; wherein the device is configured such that, when the nosepiece is fitted to the nostril of the subject and the mouthpiece is fitted to the oral cavity of the subject, oral exhalation by the subject through the mouthpiece, through the substance containing unit, and through the nosepiece acts to close the oropharyngeal velum of the subject and produce an exhalation flow passing into one nasal passage of the subject and out of the other nasal passage of the subject, thereby achieving a bi-directional exhalation flow for delivering the powdered sumatriptan substance to a portion of the nasal cavity of the subject. 10. The device of claim 9, wherein the powdered sumatriptan substance comprises a sumatriptan base or sumatriptan succinate. 11. The device of claim 9, wherein the powdered sumatriptan substance contains only sumatriptan succinate and no introduced excipients or adjuvants. 12. The device of claim 9, wherein the powdered sumatriptan substance to be delivered to the nasal cavity of the subject is disposed in a substance container. 13. The device of claim 12, wherein the substance container is a capsule. 14. The device of claim 12, wherein the substance container contains a 10 mg dose of the powdered sumatriptan substance. 15. The device of claim 9, wherein the powdered sumatriptan substance to be delivered to the nasal cavity of the subject is disposed in a capsule. 16. The device of claim 9, wherein the powdered sumatriptan substance has a particle size distribution in which at least 10% of the particles are less than about 10 .mu.m and at least 90% of the particles are less than about 90 .mu.m. 17. The device of claim 9, further including a labyrinthine structure disposed between the mouthpiece and the substance containing unit.