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出自识林

2016-04-30 Lachman CONSULTANTS

4月12日，FDA药品审评与研究中心（CDER）监管项目副主任Douglas Throckmorton在国际植物药科学会议/美国生药学会（ICSB/ASP）联合会议上作了题为“FDA对大麻的监管：过去的行动，未来的计划”的演讲（ppt）。相当有趣的是提到FDA在相当长的一段时间一直积极参与大麻产品的监管评估。例如，FDA已经批准两个产品，1985年批准Marinol（屈大麻酚）用于因化疗引起的恶心呕吐，和Cesamet（大麻隆）（1985年批准，2006年批准新适应症）用于恶心和神经性疼痛。目前Marinol已有仿制药获批，但Cesamet还没有。

报告概述了FDA支持大麻来源产品科学研发的目标。由于社区公开表明大麻的优点，FDA还有责任确保进入州际贸易声明含有大麻素的产品得到适当监管和没有虚假宣传；因此，FDA对非法产品和声明未经证实内容（即使是自称含有大麻成分，但实际上并不含）的产品具有很强的执法立场。

科学研究仍在继续，有其它新产品在研，并且有一些已在欧洲获得批准。报告指出，美国有23个州认可“医用大麻”，4个州（阿拉斯加、科罗拉多、俄勒冈、华盛顿）和哥伦比亚特区已经批准娱乐性使用大麻，13个州认可大麻素用于医疗用途。

尽管国家法律相对宽松，大麻仍是I类管制药物（没有认可医疗用途），并且从联邦法律角度来看是非法的。

根据美国缉毒局（DEA）对I类管制药物的定义，“I类管制药物、成分或化学品是指目前不被接受作为医疗用途，并具有高滥用可能性的药物。I类管制药物是所有管制药物中最危险的药物，具有潜在严重心理或生理依赖。I类管制药物举例如下：海洛因、麦角酰二乙胺（LSD）、大麻（大麻类）、3,4-亚甲二氧基（摇头丸）、安眠酮和佩奥特掌。”（参考来源：DEA官网）

医学界和制药界对大麻产品有很大兴趣。在许多方面有很高预期，但是在治疗方法被广泛使用之前，科学家们必须给出临床益处。有一些有趣的事情正在显现，例如，在小儿癫痫中的使用，用于癌症疼痛和痉挛、婴儿痉挛症和其它许多病症。

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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Up in Smoke
By Bob Pollock | April 29, 2016

Well, not really-but on April 12, 2016 (my birthday), the FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER) gave a presentation (here) entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.” It is quite interesting to note that FDA has been actively involved in the regulatory assessment of cannabinoid products for quite some time. For instance, FDA has approved two products, Marinol (dronabinol) in 1985 for nausea from chemotherapy and Cesamet (nabilone) (in 1985 and new indication in 2006) for nausea and neuropathic pain. There are currently generics approved for Marinol, but none yet for Cesamet.

The presentation outlines FDA’s goal to support the scientific development of products sourced from cannabinoids. As the virtues of marijuana are professed by the community, FDA also has a duty to assure that products placed into interstate commerce that claim to contain cannabinoids are properly regulated and that no false claims are made; thus, they have a strong enforcement posture relative to illegal products and products that make unsubstantiated claims, even if they profess to contain such ingredients and, in fact, don’t.

Scientific study continues and there are other new products in development, as well as some approved in Europe. The presentation indicates that there are 23 states that have recognized “medical marijuana,” 4 states (AK, CO, OR, and WA) and the District of Columbia that have approved the recreational use of marijuana, and 13 states recognizing cannabidiol for medical use.

Despite the relative easing of state laws, marijuana is still a Schedule I drug (with no recognized medical use) and is illegal from a federal statutory perspective.

There is lots of interest in the medical community, as well in the pharmaceutical industry. There are “high” expectations from many, but the “budding” scientists must deliver on the clinical goods before there is widespread planting of this method of treatment in the community. There are interesting things on the horizon, such as use in pediatric epilepsy, for cancer pain and spasticity, infantile spasms, and many other conditions.