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    ONE-AND TWO-POINT TITRATION METHODS TO DETERMINE DAILY TREATMENT REGIMENS TO TREAT HYPOGONADISM OR MALE TESTOSTERONE DEFICIENCY WITH AN INTRANASAL TESTOSTERONE BIO-ADHESIVE GEL, AND PRIMARY AND SECONDARY EFFICACY AND SAFETY ENDPOINTS
    1.
    发明申请
    ONE-AND TWO-POINT TITRATION METHODS TO DETERMINE DAILY TREATMENT REGIMENS TO TREAT HYPOGONADISM OR MALE TESTOSTERONE DEFICIENCY WITH AN INTRANASAL TESTOSTERONE BIO-ADHESIVE GEL, AND PRIMARY AND SECONDARY EFFICACY AND SAFETY ENDPOINTS 审中-公开
    一次和两点测定方法，用于确定每日治疗方案，以治疗原发性静脉内皮细胞生长抑制凝胶，以及主要和次要效力和安全终点

    公开(公告)号：WO2014080282A2

    公开(公告)日：2014-05-30

    申请号：PCT/IB2013/002920

    申请日：2013-11-22

    Applicant: TRIMEL BIOPHARMA SRL

    Inventor： MAES, Paul, Jose, Pierre, Marie ,  KREPPNER, Wayne ,  DICKSTEIN, Jodi, Beth ,  TKACHENKO, Natalia

    IPC: A61K31/5685

    CPC classification number: A61K31/568

    Abstract: The present invention relates to 4.0% and 4.5% intranasal testosterone bio- adhesive gels for providing sustained intranasal delivery of testosterone to a male and intranasal treatment methods for safely providing sustained release testosterone to treat males with hypogonadism. In particular, the present invention relates to improved testosterone replacement therapy (TRT) and sustained intranasal testosterone gel formulations for treating male hypogonadism. The 4.0% and 4.5% intranasal testosterone bio-adhesive gels are effective, are statistically significant regarding improvement in effect on erectile function and mood, provide for favourable trends for effect on body composition and bone mineral density and have safety measures after 360 days of treatment that are consistent with currently marketed topical testosterone products. The present invention also relates to a system for dispensing intranasally a precise dosage amount of such gels in smaller volumes at an optimal anatomical location within each nostril of the male, so that an effective amount of testosterone is deposited within each nostril at the optimal anatomical location for TRT, including to effectively treat testosterone deficiency in male subjects, such as hypogonadism. The present invention is also concerned with a novel titration method to determine the appropriate daily treatment regimen, i.e., a BID or TID treatment regimen, to administer the intranasal gels of the present invention to treat hypogonadism or TRT. The present invention is also concerned with novel titrations method to determine the appropriate daily treatment regimen, i.e., a QD, BID or TID treatment regimen, to administer the intranasal gels of the present invention to treat hypogonadism or TRT in males. In particular, the present testosterone therapy remains effective for treating hypogonadism when an allergic rhinitis event occurs in the male or when the male subject uses a topical nasal vasoconstrictor or a topical intranasal decongestant during the hypogonadism treatment. Further, the present invention relates to a novel method of preventing the occurrence of an allergic rhinitis event in a male, who is undergoing a hypogonadism treatment with an intranasal testosterone bio-adhesive gel formulation. In certain embodiments, the intranasal testosterone bio-adhesive gel formulation according to the invention comprises 4.0% and 4.5% testosterone.

    Abstract translation: 本发明涉及4.0％和4.5％的鼻内睾丸激素生物粘合凝胶，用于向男性和鼻内治疗方法提供持续的鼻内递送睾酮，以安全地提供持续释放的睾酮以治疗性腺机能减退的男性。 特别地，本发明涉及改善的睾酮替代疗法（TRT）和用于治疗男性性腺功能减退症的持续性鼻内睾酮凝胶制剂。 4.0％和4.5％的鼻内睾丸激素生物粘附凝胶是有效的，对勃起功能和心情的改善有统计学意义，为身体组成和骨矿物质密度的影响提供有利的趋势，并在治疗360天后采取安全措施 这与目前市售的局部睾丸激素产品是一致的。 本发明还涉及一种用于在男性的每个鼻孔内的最佳解剖学位置以较小体积鼻内分配精确剂量的这种凝胶的系统，使得有效量的睾酮沉积在每个鼻孔内的最佳解剖位置 用于TRT，包括有效治疗男性受试者的睾酮缺乏症，如性腺机能减退等。 本发明还涉及一种新颖的滴定方法来确定适当的每日治疗方案，即BID或TID治疗方案，以施用本发明的鼻内凝胶来治疗性腺机能减退或TRT。 本发明还涉及用于确定适当的日常治疗方案（即QD，BID或TID治疗方案）的新滴定方法，以施用本发明的鼻内凝胶来治疗男性性腺机能减退或TRT。 特别地，当男性发生过敏性鼻炎事件时，或男性受试者在性腺机能减退治疗期间使用局部鼻腔血管收缩剂或局部鼻内减充血药时，目前的睾丸激素治疗仍然有效治疗性腺机能减退症。 此外，本发明涉及一种在用鼻内睾丸激素生物粘附凝胶制剂进行性腺机能减退治疗的男性中预防过敏性鼻炎事件发生的新方法。 在某些实施方案中，根据本发明的鼻内睾酮生物粘合凝胶制剂包含4.0％和4.5％的睾酮。

    CONTROLLED RELEASE TOPICAL TESTOSTERONE FORMULATIONS AND METHODS
    2.
    发明申请
    CONTROLLED RELEASE TOPICAL TESTOSTERONE FORMULATIONS AND METHODS 审中-公开
    控制释放主题的TESTOSTERONE配方和方法

    公开(公告)号：WO2014076569A3

    公开(公告)日：2014-07-17

    申请号：PCT/IB2013002913

    申请日：2013-11-14

    Applicant: TRIMEL BIOPHARMA SRL

    Inventor： OBEREGGER WERNER ,  MAES PAUL JOSE PIERRE MARIE

    IPC: A61K31/56

    CPC classification number: A61K31/568 ,  A61K9/0014 ,  A61K9/0043 ,  A61K47/02 ,  A61K47/10 ,  A61K47/14 ,  A61K47/22 ,  A61K47/26 ,  A61K47/32 ,  A61K47/38 ,  A61K47/44 ,  A61M35/003

    Abstract: The present invention relates to testosterone topical formulations, especially high testosterone concentration formulations, such as between about 6% to about 15% w/w or higher, 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 or testosterone transference, following topical administration. 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

    Abstract translation: 本发明涉及睾酮局部制剂，特别是高睾酮浓度制剂，例如约6％至约15％w / w或更高，用于将睾酮控制释放到男性和女性的全身循环中，以提供恒定的有效睾丸激素 血液水平，在局部给药后，不引起血液水平或睾丸激素转移期间的不期望的睾酮峰值。 本发明还涉及本发明的鼻睾酮凝胶的鼻内给药的方法和预填充多剂量无空气给药系统

    CONTROLLED RELEASE TOPICAL TESTOSTERONE FORMULATIONS AND METHODS
    6.
    发明申请
    CONTROLLED RELEASE TOPICAL TESTOSTERONE FORMULATIONS AND METHODS 审中-公开
    控制释放主题的TESTOSTERONE配方和方法

    公开(公告)号：WO2014076569A2

    公开(公告)日：2014-05-22

    申请号：PCT/IB2013/002913

    申请日：2013-11-14

    Applicant: TRIMEL BIOPHARMA SRL

    Inventor： OBEREGGER, Werner ,  MAES, Paul, Jose, Pierre, Marie

    IPC: A61K31/5685

    CPC classification number: A61K31/568 ,  A61K9/0014 ,  A61K9/0043 ,  A61K47/02 ,  A61K47/10 ,  A61K47/14 ,  A61K47/22 ,  A61K47/26 ,  A61K47/32 ,  A61K47/38 ,  A61K47/44 ,  A61M35/003

    Abstract: The present invention relates to testosterone topical formulations, especially high testosterone concentration formulations, such as between about 6% to about 15% w/w or higher, 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 or testosterone transference, following topical administration. The testosterone topical formulations 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 testosterone topical formulation of the present invention mimic or restore testosterone blood levels to normal physiologic daily rhythmic testosterone levels, the novel testosterone topical formulation 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.

    Abstract translation: 本发明涉及睾酮局部制剂，特别是高睾酮浓度制剂，例如约6％至约15％w / w或更高，用于将睾酮控制释放到男性和女性的全身循环中，以提供恒定的有效睾丸激素 血液水平，在局部给药后，不引起血液水平或睾丸激素转移期间的不期望的睾酮峰值。 本发明的睾酮局部制剂安全，使用方便，耐受性良好，稳定且容易且可重复地按比例制造。 此外，因为认为超正常和亚正常的睾酮血液水平基本上保持在最小或避免，并且认为睾酮血清水平在剂量寿命期间基本上保持不变，即本发明的睾酮局部制剂模拟 或将睾酮血液水平恢复至正常的生理日常韵律睾酮水平，本发明的新型睾酮局部制剂独特地适用于睾酮替代或补充治疗，并且有效治疗诊断患有例如男性睾酮缺乏症的男性，例如低 性欲低下，性行为低，性活动低，生育能力低，精子发生，精子发生，抑郁和/或性腺机能减退等症状，以及被诊断患有女性性功能障碍的女性，如性欲低下，性欲低下， 低性活动，低杏仁体反应性，低性刺激，性欲低下 疾病（“HSDD”），女性性唤醒障碍和/或恶病质。 本发明还涉及本发明的鼻睾酮凝胶的鼻内给药的方法和预填充多剂量无空气涂抹器系统。

    MALE TESTOSTERONE TITRATION METHODS, INTRANASAL TESTOSTERONE BIO-ADHESIVE GEL FORMULATIONS AND TREATMENT OF HYPOGONADISM AND TRT
    7.
    发明申请
    MALE TESTOSTERONE TITRATION METHODS, INTRANASAL TESTOSTERONE BIO-ADHESIVE GEL FORMULATIONS AND TREATMENT OF HYPOGONADISM AND TRT 审中-公开
    男性TESTOSTERONE TITRATION METHODS，INTRANASAT TESTOSTERONE BIO-ADHESIVE GEL FORMULATIONS AND TREATMENT OF HYPOGONADISM AND TRT

    公开(公告)号：WO2014080283A3

    公开(公告)日：2014-11-13

    申请号：PCT/IB2013002925

    申请日：2013-11-21

    Applicant: TRIMEL BIOPHARMA SRL

    Inventor： KREPPNER WAYNE ,  MAES PAUL JOSE PIERRE MARIE

    IPC: A61K31/568 ,  A61K9/06 ,  A61P5/26 ,  A61P15/00 ,  A61P15/10 ,  A61P15/12

    CPC classification number: A61K31/568 ,  A61K9/0043 ,  A61K9/06 ,  A61K47/02 ,  A61K47/14 ,  A61K47/44 ,  G01N33/743 ,  G06F19/3456

    Abstract: The present invention relates to pernasal testosterone bio-adhesive gel formulations for intranasal administration and testosterone replacement treatment methods for using the pernasal testosterone bio-adhesive gel formulations for providing sustained intranasal delivery of testosterone to testosterone deficient males to treat, for example, male subjects diagnosed with hypogonadism. The present invention is also concerned with a novel titration method to determine the appropriate daily treatment regimen, i.e., a BID or TID treatment regimen, to administer the intranasal gels of the present invention to treat hypogonadism or TRT.

    Abstract translation: 本发明涉及用于鼻内给药的经鼻睾酮生物粘合剂凝胶制剂和用于使用经鼻睾酮生物粘合凝胶制剂的睾酮替代治疗方法，用于向睾酮缺乏的男性提供持续的鼻内递送睾酮以治疗例如被诊断的男性受试者 伴有性腺功能减退症。 本发明还涉及一种新颖的滴定方法来确定适当的每日治疗方案，即BID或TID治疗方案，以施用本发明的鼻内凝胶来治疗性腺机能减退或TRT。

    ONE- AND TWO-POINT TITRATION METHODS TO DETERMINE DAILY TREATMENT REGIMENS TO TREAT HYPOGONADISM OR TESTOSTERONE DEFICIENCY
    8.
    发明申请
    ONE- AND TWO-POINT TITRATION METHODS TO DETERMINE DAILY TREATMENT REGIMENS TO TREAT HYPOGONADISM OR TESTOSTERONE DEFICIENCY 审中-公开
    用于确定每日治疗方案的单一和两点倾斜方法治疗高血糖或维生素D缺乏症

    公开(公告)号：WO2014080282A3

    公开(公告)日：2014-11-06

    申请号：PCT/IB2013002920

    申请日：2013-11-22

    Applicant: TRIMEL BIOPHARMA SRL

    Inventor： MAES PAUL JOSE PIERRE MARIE ,  KREPPNER WAYNE ,  DICKSTEIN JODI BETH ,  TKACHENKO NATALIA

    IPC: A61K31/568 ,  A61K9/06 ,  A61P5/26 ,  A61P15/00 ,  A61P15/10 ,  A61P15/12

    CPC classification number: A61K31/568

    Abstract: The present invention relates to 4.0% and 4.5 % intranasal testosterone bioadhesive gels for providing sustained intranasal delivery of testosterone to a male and intranasal treatment methods for safely providing sustained release testosterone to treat males with hypogonadism. The present invention also relates to a system for dispensing intranasally a precise dosage amount of such gels in smaller volumes at an optimal anatomical location within each nostril of the male, so that an effective amount of testosterone is deposited within each nostril at the optimal anatomical location for TRT, including to effectively treat testosterone deficiency in male subjects, such as hypogonadism. The present invention is also concerned with a novel titration method to determine the appropriate daily treatment regimen, i.e., a BID or TIO treatment regimen. Further, the present invention relates to a novel method of preventing the occurrence of an allergic rhinitis event in a male.

    Abstract translation: 本发明涉及4.0％和4.5％的鼻内睾酮生物粘附凝胶，用于向男性和鼻内治疗方法提供持续的鼻内递送睾丸激素以安全地提供持续释放的睾酮以治疗性腺机能减退的男性。 本发明还涉及一种用于在男性的每个鼻孔内的最佳解剖学位置以较小体积鼻内分配精确剂量的这种凝胶的系统，使得有效量的睾酮沉积在每个鼻孔内的最佳解剖位置 用于TRT，包括有效治疗男性受试者的睾酮缺乏症，如性腺机能减退等。 本发明还涉及一种新的滴定法来确定适当的日常治疗方案，即BID或TIO治疗方案。 此外，本发明涉及一种预防男性变应性鼻炎事件发生的新方法。

    MALE TESTOSTERONE TITRATION METHODS, MALE INTRANASAL TESTOSTERONE BIO-ADHESIVE GEL FORMULATIONS AND USE THEREOF FOR TREATING HYPOGONADISM AND TRT
    9.
    发明申请
    MALE TESTOSTERONE TITRATION METHODS, MALE INTRANASAL TESTOSTERONE BIO-ADHESIVE GEL FORMULATIONS AND USE THEREOF FOR TREATING HYPOGONADISM AND TRT 审中-公开
    男性TESTOSTERONE TITRATION方法，男性西药试验机生物胶粘剂制剂及其用于治疗高血压和TRT的用途

    公开(公告)号：WO2014080283A2

    公开(公告)日：2014-05-30

    申请号：PCT/IB2013/002925

    申请日：2013-11-21

    Applicant: TRIMEL BIOPHARMA SRL

    Inventor： KREPPNER, Wayne ,  MAES, Paul, Jose, Pierre, Marie

    IPC: A61K31/5685

    CPC classification number: A61K31/568 ,  A61K9/0043 ,  A61K9/06 ,  A61K47/02 ,  A61K47/14 ,  A61K47/44 ,  G01N33/743 ,  G06F19/3456

    Abstract: The present invention relates to pernasal testosterone bio-adhesive gel formulations for intranasal administration and testosterone replacement treatment methods for using the pernasal testosterone bio-adhesive gel formulations for providing sustained intranasal delivery of testosterone to testosterone deficient males to treat, for example, male subjects diagnosed with hypogonadism. The present invention is also concerned with a novel titration method to determine the appropriate daily treatment regimen, i.e., a BID or TID treatment regimen, to administer the intranasal gels of the present invention to treat hypogonadism or TRT.

    Abstract translation: 本发明涉及用于鼻内给药的经鼻睾酮生物粘合剂凝胶制剂和用于使用经鼻睾酮生物粘合凝胶制剂的睾酮替代治疗方法，用于向睾酮缺乏的男性提供持续的鼻内递送睾酮以治疗例如被诊断的男性受试者 伴有性腺功能减退症。 本发明还涉及一种新颖的滴定方法来确定适当的每日治疗方案，即BID或TID治疗方案，以施用本发明的鼻内凝胶来治疗性腺机能减退或TRT。

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