Baidu
map

酗酒成瘾新疗法!FDA重新启动针对AD04研究性新药申请的审核

2020-10-22 Allan MedSci原创

酒精使用障碍(AUD)是一种精神障碍,具有多病因的慢性疾病,与多种的躯体和精神后遗症有关。耐受、戒断、饮酒行为的控制力受损以及不顾不良后果而持续饮酒是酒精依赖的一些重要常见特征。

酒精使用障碍(AUD)是一种精神障碍,具有多病因的慢性疾病,与多种的躯体和精神后遗症有关。耐受、戒断、饮酒行为的控制力受损以及不顾不良后果而持续饮酒是酒精依赖的一些重要常见特征。

生物制药公司Adial Pharmaceuticals今天宣布,美国食品药品管理局(FDA)已重新启动针对AD04研究性新药申请(IND)的审核,并允许开展AD04的临床试验。AD04是一款用于治疗酒精使用障碍(AUD)的基因靶向治疗剂。该公司将集中精力于ONWARD欧洲III期临床试验,在开始ONWARD验之前,已将制造数据并提交给了欧洲药品管理局(EMA),但是由于该试验尚未在美国进行,因此该数据尚未提交给FDA。

重新启动Adial的IND可使该公司继续追求AD04在美国的快速审查,并在美国启动I期药代动力学(PK)临床研究。

Adial Pharmaceuticals首席执行官William Stilley表示:“鉴于COVID-19大流行的长期性,酒精使用障碍(AUD)的危机将继续升级。因此,我们已向FDA申请对AD04进行快速审查”。

 

原始出处:

https://www.firstwordpharma.com/node/1767214?tsid=4

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1744218, encodeId=cdb61e44218d9, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Wed Jun 02 06:35:15 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=894069, encodeId=dd8b8940699a, content=酒是穿肠毒药, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Sat Oct 24 09:00:59 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1554590, encodeId=e73a15545904a, content=<a href='/topic/show?id=74e458559f5' target=_blank style='color:#2F92EE;'>#新疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58559, encryptionId=74e458559f5, topicName=新疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d03114536414, createdName=kcb074, createdTime=Sat Oct 24 00:35:15 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893858, encodeId=a8dd893858f7, content=这个药是什么机制的呢?, beContent=null, objectType=article, channel=null, level=null, likeNumber=164, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/94bc90bf9c1648a79219a35a6e3e71b4/cbaeac86de0341e9a4b8a5ac6e3c709e.jpg, createdBy=8b795288851, createdName=1485bc56m93暂无昵称, createdTime=Thu Oct 22 22:42:54 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893689, encodeId=c7b489368961, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/fa0e89977d944647ad9dfe2fe5557c1d/c6328f7060bb4e3685a6ff359c385dda.jpg, createdBy=c9002433942, createdName=123c118dm76暂无昵称, createdTime=Thu Oct 22 09:56:45 CST 2020, time=2020-10-22, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1744218, encodeId=cdb61e44218d9, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Wed Jun 02 06:35:15 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=894069, encodeId=dd8b8940699a, content=酒是穿肠毒药, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Sat Oct 24 09:00:59 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1554590, encodeId=e73a15545904a, content=<a href='/topic/show?id=74e458559f5' target=_blank style='color:#2F92EE;'>#新疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58559, encryptionId=74e458559f5, topicName=新疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d03114536414, createdName=kcb074, createdTime=Sat Oct 24 00:35:15 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893858, encodeId=a8dd893858f7, content=这个药是什么机制的呢?, beContent=null, objectType=article, channel=null, level=null, likeNumber=164, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/94bc90bf9c1648a79219a35a6e3e71b4/cbaeac86de0341e9a4b8a5ac6e3c709e.jpg, createdBy=8b795288851, createdName=1485bc56m93暂无昵称, createdTime=Thu Oct 22 22:42:54 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893689, encodeId=c7b489368961, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/fa0e89977d944647ad9dfe2fe5557c1d/c6328f7060bb4e3685a6ff359c385dda.jpg, createdBy=c9002433942, createdName=123c118dm76暂无昵称, createdTime=Thu Oct 22 09:56:45 CST 2020, time=2020-10-22, status=1, ipAttribution=)]
    2020-10-24 liyu7822

    酒是穿肠毒药

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1744218, encodeId=cdb61e44218d9, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Wed Jun 02 06:35:15 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=894069, encodeId=dd8b8940699a, content=酒是穿肠毒药, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Sat Oct 24 09:00:59 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1554590, encodeId=e73a15545904a, content=<a href='/topic/show?id=74e458559f5' target=_blank style='color:#2F92EE;'>#新疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58559, encryptionId=74e458559f5, topicName=新疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d03114536414, createdName=kcb074, createdTime=Sat Oct 24 00:35:15 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893858, encodeId=a8dd893858f7, content=这个药是什么机制的呢?, beContent=null, objectType=article, channel=null, level=null, likeNumber=164, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/94bc90bf9c1648a79219a35a6e3e71b4/cbaeac86de0341e9a4b8a5ac6e3c709e.jpg, createdBy=8b795288851, createdName=1485bc56m93暂无昵称, createdTime=Thu Oct 22 22:42:54 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893689, encodeId=c7b489368961, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/fa0e89977d944647ad9dfe2fe5557c1d/c6328f7060bb4e3685a6ff359c385dda.jpg, createdBy=c9002433942, createdName=123c118dm76暂无昵称, createdTime=Thu Oct 22 09:56:45 CST 2020, time=2020-10-22, status=1, ipAttribution=)]
    2020-10-24 kcb074
  4. [GetPortalCommentsPageByObjectIdResponse(id=1744218, encodeId=cdb61e44218d9, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Wed Jun 02 06:35:15 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=894069, encodeId=dd8b8940699a, content=酒是穿肠毒药, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Sat Oct 24 09:00:59 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1554590, encodeId=e73a15545904a, content=<a href='/topic/show?id=74e458559f5' target=_blank style='color:#2F92EE;'>#新疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58559, encryptionId=74e458559f5, topicName=新疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d03114536414, createdName=kcb074, createdTime=Sat Oct 24 00:35:15 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893858, encodeId=a8dd893858f7, content=这个药是什么机制的呢?, beContent=null, objectType=article, channel=null, level=null, likeNumber=164, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/94bc90bf9c1648a79219a35a6e3e71b4/cbaeac86de0341e9a4b8a5ac6e3c709e.jpg, createdBy=8b795288851, createdName=1485bc56m93暂无昵称, createdTime=Thu Oct 22 22:42:54 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893689, encodeId=c7b489368961, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/fa0e89977d944647ad9dfe2fe5557c1d/c6328f7060bb4e3685a6ff359c385dda.jpg, createdBy=c9002433942, createdName=123c118dm76暂无昵称, createdTime=Thu Oct 22 09:56:45 CST 2020, time=2020-10-22, status=1, ipAttribution=)]
    2020-10-22 1485bc56m93暂无昵称

    这个药是什么机制的呢?

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1744218, encodeId=cdb61e44218d9, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Wed Jun 02 06:35:15 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=894069, encodeId=dd8b8940699a, content=酒是穿肠毒药, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Sat Oct 24 09:00:59 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1554590, encodeId=e73a15545904a, content=<a href='/topic/show?id=74e458559f5' target=_blank style='color:#2F92EE;'>#新疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58559, encryptionId=74e458559f5, topicName=新疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d03114536414, createdName=kcb074, createdTime=Sat Oct 24 00:35:15 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893858, encodeId=a8dd893858f7, content=这个药是什么机制的呢?, beContent=null, objectType=article, channel=null, level=null, likeNumber=164, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/94bc90bf9c1648a79219a35a6e3e71b4/cbaeac86de0341e9a4b8a5ac6e3c709e.jpg, createdBy=8b795288851, createdName=1485bc56m93暂无昵称, createdTime=Thu Oct 22 22:42:54 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=893689, encodeId=c7b489368961, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201022/fa0e89977d944647ad9dfe2fe5557c1d/c6328f7060bb4e3685a6ff359c385dda.jpg, createdBy=c9002433942, createdName=123c118dm76暂无昵称, createdTime=Thu Oct 22 09:56:45 CST 2020, time=2020-10-22, status=1, ipAttribution=)]

相关资讯

Hepatology:酒精使用障碍和酒精性肝硬化,竟能使用粪便微生物群移植进行治疗?

酒桌文化在人类历史中源远流长,酒精也是目前使用最广泛的精神活性物质。据世卫组织统计,目前全球饮酒人数约有23亿,而其中约有2.37亿男性和4600万女性罹患有酒精使用障碍(AUD),其表现为对酒精作用

JAMA Intern Med:加巴喷丁用于治疗酒精使用障碍

加巴喷丁对酒精使用障碍患者具有积极作用

JAMA:减重手术可增加酒精使用障碍

  以往常有媒体报道减重手术可能增加酒精使用障碍(AUD)风险,但是缺乏严谨的科学研究加以证实。2012年6月20日《美国医学会杂志》(JAMA)在线发表的一篇文章表明,减重手术后2年AUD发生率较术前及术前1年增加,且与性别、年轻、术前情况(吸烟、饮酒量、AUD、娱乐性药物使用以及归属感低下)和接受Roux-en-Y 胃旁路手术相关。   该项前瞻性队列研究(减重手术纵向评估-2)2006~2

拓展阅读

Molecular Psychiatry:急性大麻二酚(CBD)给药减少酒精渴望及其引发的伏隔核激活:ICONIC双盲随机对照试验

急性CBD给药显著降低了酒精线索引发的伏隔核激活,并减少了酒精渴望。CBD组在酒精渴望评分上变化较小,且CBD血浆浓度与治疗效果呈负相关,显示出CBD在治疗酒精使用障碍中的潜在作用。

Translational Psychiatry:纳曲酮阻断酒精诱导的κ-阿片受体膜质效应

酒精和纳曲酮在κ-阿片受体膜质动态中的相互作用。酒精通过改变KOP受体与膜脂环境的相互作用来影响其功能,而纳曲酮不仅通过经典的KOP拮抗作用,还通过调节膜脂环境和KOP受体的聚集来抵抗酒精的影响。

常用降糖、减肥药,还能用于戒酒?JAMA子刊:这两种药作用更佳

近日,JAMA Psychiatry发表一项研究,结果以简短报告的形式发布,表明GLP-1 RA中的司美格鲁肽和利拉鲁肽有助于减少酒精使用障碍患者的饮酒量,降低住院风险。

Molecular Psychiatry:与酒精使用障碍相关的人脑基因表达差异

研究发现与酒精使用障碍相关的多个差异表达基因,揭示了NAc和DLPFC在成瘾中的潜在分子机制。Meta分析进一步验证了这些结果,并通过药物再利用分析提出了潜在的治疗靶点。

Molecular Psychiatry:中枢GHSR拮抗剂降低小鼠类暴饮暴食型饮酒行为

中枢GHSR拮抗剂能够有效减少小鼠的暴饮暴食型饮酒行为,且与外周ghrelin水平无关。即使在外周ghrelin水平显著降低的情况下,GHSR拮抗剂仍然表现出显著的饮酒抑制作用。

Nature Metabolism:NIH高斌教授团队揭示酒精代谢新概念:肝-肠轴调控解毒与饮酒行为

该项研究表明,肝-肠轴相较于单独的肝脏作用,能够协调作用促进系统AcH的清除和调控饮酒行为。

Baidu
map
Baidu
map
Baidu
map