Title:
The gel in a gradual release testosterone nasal cavity, method, and two or more times dosage pre fill applicator system for nasal administration
Document Type and Number:
Japanese Patent JP6152092
Kind Code:
B2
Abstract:
The present invention relates to intranasal testosterone gels for the controlled release of testosterone into the systemic circulation of males and females for providing constant effective testosterone blood levels, without inducing undesired testosterone spike in blood levels, following pernasal administration. The intranasal testosterone gels of the present invention are safe, convenient to use, well tolerated, stable and easily and reproducibly manufactured on scale up. Moreover, because supra- normal and sub-normal testosterone blood levels are believed to be essentially kept to a minimum or avoided and the testosterone serum levels are believed to remain essentially constant during dose life, i.e., the intranasal testosterone gels of the present invention mimic or restore testosterone blood levels to normal physiologic daily rhythmic testosterone levels, the novel intranasal testosterone gels of the present invention are uniquely suited for testosterone replacement or supplemental therapy and effective for treating males diagnosed with, for example, male testosterone deficiency, such as, low sexual libido, low sexual drive, low sexual activity, low fertility, low spermatogenesis, aspermatogenesis, depression and/or hypogonadism, and females who are diagnosed with, for example, female sexual dysfunction, such as, low sexual libido, low sexual drive, low sexual activity, low amygdala reactivity, low sexual stimulation, hypoactive sexual desire disease ("HSDD"), female sexual arousal disorder and/or anorgasmia. The present invention also relates to methods and pre- filled multi-dose airless applicator systems for pernasal administration of the nasal testosterone gels of the present invention.
Inventors:
Kleppner, Wayne
Fogarty, Chevron
Obergar, Warner
Mae, paul, jose, pierre, marie
Fogarty, Chevron
Obergar, Warner
Mae, paul, jose, pierre, marie
Application Number:
JP2014510901A
Publication Date:
June 28, 2017
Filing Date:
May 15, 2012
Export Citation:
Assignee:
Aceras Pharmaceuticals Corporation
International Classes:
A61K31/568; A61K9/06; A61K47/04; A61K47/08; A61K47/10; A61K47/14; A61K47/22; A61K47/32; A61K47/38; A61K47/44; A61M11/00; A61P5/26; A61P15/08; A61P15/10; A61P25/24
Domestic Patent References:
| JP2007524589A | ||||
| JP53079020A |
Foreign References:
| US20100311707 |
Other References:
The Aging Male,2008年,vol.11, no.4,p.171-178,DOI:10.1080/13685530802351974
Attorney, Agent or Firm:
Ryoichi Takaoka
Nao Oda
Kaoru Takahashi
Nao Oda
Kaoru Takahashi
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