CN1853619A - 阿戈美拉汀在获得用于治疗双相性精神障碍的药物中的用途 - Google Patents
阿戈美拉汀在获得用于治疗双相性精神障碍的药物中的用途 Download PDFInfo
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Abstract
本发明涉及阿戈美拉汀或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺独自或组合在获得药物中的用途,所述的药物用于治疗双相性精神障碍、特别是I型和II型双相性精神障碍、更特别是I型双相性精神障碍。
Description
技术领域
本发明涉及阿戈美拉汀(agomelatine)或式(I)的N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺以及其水合物、晶形和与可药用酸或碱的加成盐独自或组合在获得药物中的用途,
所述的药物用于治疗双相性精神障碍、特别是I型和II型双相性精神障碍、更特别是I型双相性精神障碍。
背景技术
阿戈美拉汀,或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺,拥有双重的特性,一方面它是褪黑激素能系统受体的激动剂,另一方面,它又是5-HT2C受体的拮抗剂。这些性质使得它在中枢神经系统中有活性,更特别是在治疗重症抑郁、季节性情感障碍、睡眠障碍、心血管疾病、消化系统疾病、时差导致的失眠和疲惫、食欲障碍和肥胖中有活性。
阿戈美拉汀、其制备及在治疗上的用途已经公开在欧洲专利说明书EP0 447 285和EP 1 564 202中。
发明内容
申请人现已发现,阿戈美拉汀或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺以及它的水合物、晶形和与可药用酸或碱的加成盐独自或组合使用具有有价值的性质,这使得它们可用于治疗双相性精神障碍,特别是I型和II型双相性精神障碍,更特别是I型双相性精神障碍。
双相性精神障碍是一种对患者的生活有严重影响的精神病理性病症,这种影响既表现在社会和家庭上也表现在职业上。其特征在于通常反复出现抑郁、躁狂、轻度躁狂或混合性发作,这些发作间隔着一段患者未受重症心理功能障碍影响的时期。换句话来说,双相性精神障碍患者以对情绪反复出现显著波动的易感性为特征。发作的特性和它们随时间的发展使得区别出几种临床形式:I型双相性精神障碍是最典型的,其特征是一次或多次躁狂或混合性发作,通常伴随有重症抑郁发作;对II型双相性精神障碍而言,它包括至少一次重症抑郁发作和轻度躁狂发作(躁狂的一种缓和形式)的组合。双相性精神障碍患者的自杀风险很高,25%至50%的患者至少有一次自杀企图。
目前尚没有满意的、公认的双相性精神障碍治疗方法。一线治疗通常是情绪稳定剂或情感调节剂(thymoregulators),但这些治疗通常不能减轻抑郁症状(J.Clin.Psychiatry,2004,65(4),569-579)。虽然通常采用同服抗抑郁药,但这是一种引起激烈争论的行为,因为抗抑郁药可引发或加剧躁狂状态和混合状态,当躁狂发作出现时必须停药。抗抑郁药特别被认为可导致或加速情感增盛周期,并两至三倍地促进躁狂或轻度躁狂过程的出现,最后,它们的长期使用似乎可增加抑郁和躁狂发作的次数。
申请人现已令人惊奇地发现,阿戈美拉汀独自或组合可用于治疗双相性精神障碍,特别是I型和II型双相性精神障碍,更特别是I型双相性精神障碍。
正是由于其在抑郁中有活性这一事实,使用阿戈美拉汀治疗双相性精神障碍、更特别是I型双相性精神障碍的预期效果与文献中报道的抗抑郁药如帕罗西汀的效果相同。
令人惊奇地的是,阿戈美拉汀的行为不象常规的抗抑郁药,这一点已从在I型双相性精神障碍患者中进行的临床研究中观察到。这些结果使得考虑其在双相性精神障碍、特别是I型和II型双相性精神障碍、更特别是在I型双相性精神障碍中的使用、甚至是长期使用成为可能。
因此,本发明涉及阿戈美拉汀以及其水合物、晶形和与可药用酸或碱的加成盐独自或组合在获得药物组合物中的用途,所述的药物组合物用于治疗双相性精神障碍,特别是I型和II型双相性精神障碍,更特别是I型双相性精神障碍。
本发明还涉及阿戈美拉汀与情绪稳定剂或情感调节剂的组合,用于获得可用于治疗双相性精神障碍、特别是I型和II型双相性精神障碍、更特别是I型双相性精神障碍的药物组合物。本发明的情绪稳定剂或情感调节剂涉及锂和抗癫痫药如卡马西平、丙戊酸类和拉莫三嗪等等。更特别地,本发明的组合的情绪稳定剂或情感调节剂为锂或丙戊酸类。当阿戈美拉汀与情绪稳定剂组合时,可以在情绪稳定剂之前、同时或之后施用,条件是两次给药之间的时间间隔可使得在中枢神经系统获得预期的协同作用。如果本发明的组合的两种组分同时给药,则优选给予包含阿戈美拉汀和情绪稳定剂以及一种或多种可药用赋形剂的药物组合物。
药物组合物以适宜于通过口服、胃肠道外、经皮、鼻腔、直肠或含化途径给药的形式存在,特别是以注射剂、片剂、舌下片、glossettes、明胶胶囊、胶囊、锭剂、栓剂、乳膏、软膏、皮肤用凝胶等等的形式存在。
除了阿戈美拉汀和任选与之组合的情绪稳定剂外,本发明的药物组合物还包含一种或多种选自稀释剂、润滑剂、粘合剂、崩解剂、吸收剂、着色剂、甜味剂等的赋形剂或载体。
通过非限制实例,可能提到的有:
◆稀释剂:乳糖、葡萄糖、蔗糖、甘露醇、山梨醇、纤维素、甘油;
◆润滑剂:二氧化硅、滑石粉、硬脂酸及其镁盐和钙盐、聚乙二醇;
◆粘合剂:硅酸铝和硅酸镁、淀粉、明胶、西黄蓍胶、甲基纤维素、羧甲基纤维素钠和聚乙烯吡咯烷酮;
◆崩解剂:琼脂、藻酸及其钠盐、泡腾混合物。
有用剂量根据患者的性别、年龄和体重、给药途径、疾病的性质和任何伴随的治疗而不同,阿戈美拉汀的有用剂量为1mg至50mg/24小时。
阿戈美拉汀的日剂量优选为25mg/天。
具体实施方式
药物组合物:
每片含有25mg活性成分的1000片制剂的处方:
N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺 25g
乳糖一水合物 62g
硬脂酸镁 1.3g
聚维酮 9g
无水胶体二氧化硅 0.3g
纤维素羟乙酸钠 30g
硬脂酸 2.6g
临床研究:
本研究在21名患有I型双相性精神障碍的患者中进行,用锂(n=14)或丙戊酸(n=7)治疗至少6个月。用阿戈美拉汀(25毫克/天)治疗6周。在这些患者中,19名患者在6周急性治疗后继续治疗,这些继续治疗的患者中有11名治疗达1年。获得的结果表明:81%的患者对治疗有阳性反应,约50%的患者在仅一周治疗的末期有阳性反应。在6周治疗后只观察到3次躁狂或轻度躁狂发作,其水平完全相当于用情绪稳定剂治疗的患者,该结果清楚地表明,阿戈美拉汀在I型双相性精神障碍患者中的阳性作用不伴随有躁狂和/或轻度躁狂发作的发生率提高,甚至在长期治疗后亦如此。
Claims (12)
1.阿戈美拉汀或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺以及其水合物、晶形和与可药用酸或碱的加成盐在获得药物中的用途,所述的药物用于治疗双相性精神障碍。
2.阿戈美拉汀或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺以及其水合物、晶形和与可药用酸或碱的加成盐在获得药物中的用途,所述的药物用于治疗I型双相性精神障碍。
3.用于制备治疗双相性精神障碍的药物组合物,该组合物仅包含阿戈美拉汀或其水合物、晶形和与可药用酸或碱的加成盐,或者还包含一种或多种可药用赋形剂。
4.用于制备治疗I型双相性精神障碍的药物组合物,该组合物仅包含阿戈美拉汀或其水合物、晶形和与可药用酸或碱的加成盐,或者还包含一种或多种可药用赋形剂。
5.组合,包含阿戈美拉汀或其水合物、晶形和与可药用酸或碱的加成盐以及情感调节剂。
6.权利要求5的组合,其中情感调节剂为锂。
7.权利要求5的组合,其中情感调节剂为丙戊酸类。
8.药物组合物,该组合物仅包含权利要求5至7中的一项所述的组合,或者还包含一种或多种可药用赋形剂。
9.权利要求8的药物组合物,用于生产治疗双相性精神障碍的药物。
10.权利要求8的药物组合物,用于生产治疗I型双相性精神障碍的药物。
11.权利要求5至7中的一项所述的组合在获得药物组合物中的用途,所述的药物组合物用于治疗双相性精神障碍。
12.权利要求5至7中的一项所述的组合在获得药物组合物中的用途,所述的药物组合物用于治疗I型双相性精神障碍。
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FR0503937 | 2005-04-20 | ||
FR0503937A FR2884714B1 (fr) | 2005-04-20 | 2005-04-20 | Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement des troubles bipolaires |
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FR2890563B1 (fr) * | 2005-09-09 | 2007-10-19 | Servier Lab | Nouvelle association entre l'agomelatine et un agent thymoregulateur et les compositions pharmaceutiques qui la contiennent |
AU2008247805A1 (en) * | 2007-05-01 | 2008-11-13 | Concert Pharmaceuticals Inc. | Naphthyl(ethyl) acetamides |
FR2978916B1 (fr) * | 2011-08-10 | 2013-07-26 | Servier Lab | Composition pharmaceutique solide pour administration buccale d'agomelatine |
EP2856934A1 (en) * | 2013-10-04 | 2015-04-08 | Les Laboratoires Servier | Biomarkers for the prediction of long term remission in depression |
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FR2658818B1 (fr) * | 1990-02-27 | 1993-12-31 | Adir Cie | Nouveaux derives a structure naphtalenique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent. |
US5585118A (en) * | 1995-06-02 | 1996-12-17 | Brigham And Women's Hospital | Choline in the treatment of bipolar disorder |
NZ527989A (en) * | 2001-02-27 | 2005-12-23 | Ortho Mcneil Pharm Inc | Use of a halogenated 2-phenyl-1,2-ethanediol dicarbamate enantiomer or enantiomeric mixture wherein one enantiomer predominates for preventing or treating bipolar disorder |
FR2834890B1 (fr) * | 2002-01-23 | 2004-02-27 | Servier Lab | Composition pharmaceutique orodispersible d'agomelatine |
AR047553A1 (es) * | 2003-07-04 | 2006-01-25 | Lundbeck & Co As H | La combinacion de un inhibidor de reabsorcion de serotonina y agomelatina |
US20050164987A1 (en) * | 2003-12-24 | 2005-07-28 | Barberich Timothy J. | Melatonin combination therapy for improving sleep quality |
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