Ketamine Hydrochloride

The Drug Enforcement Administration on Wednesday issued a long-awaited proposed rule that would create a permanent process for clinicians to more easily prescribe controlled drugs online. The proposal would create a special registration process allowing telehealth doctors and mid-level practitioners to prescribe potentially addictive controlled substances without seeing a patient in person first, as federal law typically requires. Prescribing online without an initial in-person evaluation has been permitted by the DEA since the start of the Covid-19 public health emergency, thanks to several temporary extensions. A number of venture-backed telehealth companies grew rapidly as a result. Most recently, in November, the agency extended this flexibility until the end of 2025, after industry groups sounded the alarm that patients were poised to lose access to needed treatments. The proposed rule would essentially set that flexibility in stone for certain clinicians and add new requirements the DEA says are meant to expand access to care while allowing the agency better oversight. But some industry groups representing health systems, telehealth companies and other organizations that provide online care said the proposed rule may be too restrictive. In a statement, Kyle Zebley, senior vice president of public policy for the American Telemedicine Association, said that the proposed rule looks to contain “elements that represent significant operational challenges.” “All stakeholders need time to carefully review this important proposal, which appears to incorporate valuable elements and other potentially unworkable restrictions that focus on maintaining compliance with patient verification, electronic recordkeeping, and ongoing monitoring,” Zebley said. Meanwhile, the Alliance for Connected Care said it’s concerned that the proposal places limits on what portion of patient care can be offered through telemedicine and the geographies in which telemedicine can be offered. Comments on the rule are due in 60 days. Separately, the DEA and several other federal agencies finalized a rule Wednesday that allows DEA-registered clinicians to prescribe a six-month supply of buprenorphine, a controlled drug used to treat opioid use disorder, without seeing the patient in person. Those clinicians could write the buprenorphine prescription without having a special registration. Notably, the proposed rule discusses the challenges and risks associated with the recent rise of direct-to-consumer, prescription-writing telemedicine platforms. It proposes requiring companies that act as intermediaries in dispensing controlled substances to register with the DEA just like clinicians. “Although the telemedicine flexibilities during the PHE allowing practitioners to prescribe controlled substances without prior in-person medical evaluations were necessary to prevent lapses of care amid a global pandemic, it also facilitated the emergence of concerning business models engaged in the widespread diversion of controlled substances, taking advantage of the flexibilities established during the COVID-19 PHE,” the rule states. Though it doesn’t name any companies in the rule, the DEA last year fined mental health startup Cerebral for encouraging prescriptions of ADHD medications and other controlled drugs. The founder and head clinician of another startup, Done Global, were arrested and charged in June for inappropriate stimulant prescribing, according to the Justice Department. The proposed rule would create three types of special registrations: one for clinicians prescribing Schedule III through V controlled substances , which include anything from testosterone and ketamine to benzodiazepines like Xanax; another for specialized clinicians, such as psychiatrists and hospice care doctors, prescribing those and Schedule II drugs, such as stimulants and pain medication that have a higher risk of addiction and abuse; and one for telemedicine platforms dispensing Schedule II through V controlled substances. Each special registration would last for three years. In addition, the DEA would require clinicians to obtain from the agency another “state telemedicine registration” for every state in which they plan to prescribe controlled substances online. The proposed rule states that clinicians would also be subject to heightened requirements for prescriptions. For example, clinicians would need to check prescription drug monitoring programs (PDMPs) in all 50 states before writing a controlled substance prescription, though that requirement would go into effect three years after the rule is finalized. Before then, clinicians would be required to conduct a more limited PDMP check. The DEA also proposes placing limits on prescriptions for Schedule II controlled substances. It would require that the clinician with a special registration be physically located in the same state as the patient being treated. The proposed rule would also require that the clinician prescribe less than 50% of their average number of monthly prescriptions for Schedule II controlled substances through telemedicine. “Limiting the proportion of Schedule II prescriptions issued through telemedicine would help to manage the risks associated with the prescribing of Schedule II controlled substances by ensuring that a significant portion of these prescriptions are issued following in-person medical evaluations, which can provide a more comprehensive assessment of the patient’s medical history and condition than can be done remotely,” the proposed rule states. (This story is from our Health Tech newsletter. If you’d like to sign up, just click here. )

1月13日，JPMorgan大会召开之际，强生宣布了一个大消息：将以146亿美元收购一家开发中枢神经治疗药物的企业Intra-cellular。 这一金额超过了强生自己创下的2024年全球医药企业收购金额记录。去年4月，强生花费131亿美元收购Shockwave医疗，不到一年再度出手，剑指一款抗抑郁“神药”卢美哌隆。 Intra-cellular是诺贝尔奖得主Paul Greengard在2001年创立的公司，2014年在纳斯达克上市。卢美哌隆在2019年上市，到2023年销售额就达到了4.6亿美元，去年销售额有望接近7亿美元。 强生雷厉风行。周日晚对外散布正在收购谈判的消息，然后两家公司高管在JPMorgan大会上碰面，迅速敲定了这笔交易。按照Intra-cellular上周五的收盘价计算，这笔收购溢价39%。强生表示将以现金和债务结合的方式筹措资金，预计将在今年完成收购。 JPMorgan大会向来以撮合交易闻名，今年会上交易热情明显较往年升温，短短几天内至少有4笔交易消息，包括GSK出手收购IDRx，礼来提议收购Scorpion Therapeutics、Biogen“抄底”神经科学领域公司Sage Therapeutics等。 股价一路高升 卢美哌隆销售表现非常好，过去一年里Intra-Cellular股价涨幅超过30%。上周五收盘时，Intra-Cellular市值超过100亿美元，达到上市以来最高点。 强生选择在这个时候溢价收购，看来是非常看好这款精神药物。 卢美哌隆是Intra-Cellular从BMS引进的品种，2019年上市，用于治疗成人精神分裂症。2021年末，卢美哌隆斩获第二个适应症——成人双相抑郁。两大适应症支撑下，卢美哌隆展现出不俗的商业化成绩。 Intra-Cellular财报显示，2023年，卢美哌隆销售额已经达到4.62亿美元，同比增长86%；2024年，卢美哌隆继续快速放量，前三季度销售额达4.82亿美元，预计全年销售额最高可达6.85亿美元。 卢美哌隆还有更大的想象空间——抑郁症的辅助治疗。根据Intra-Cellular统计，美国抑郁症辅助治疗市场约有2100万患者，是精神分裂症的8倍，是双向情感障碍的2倍。如果能拿下这一适应症，卢美哌隆可能成为最常见抑郁症的标准治疗方法，也将成为15年来首个同时获批三种抑郁症的治疗药物。 Intra-Cellular正在加紧研发，已经开展的两项3期临床试验Study501和study502均取得了成功。上个月，公司已经向FDA提交了抑郁症辅助治疗的补充新药申请。 值得一提的是，上周五，Intra-Cellular刚与山德士达成专利和解，将卢美哌隆的专利期推迟了6年，进一步拔高了销售预期。Intra-Cellular预计，未来十年，卢美哌隆的销售峰值将达到50亿美元。 向神经科学领域倾斜 强生现金储备丰富，因此近期开展大额收购频繁，被投资银行称作并购火力最强的公司。仅2024年强生就完成了约75项收购，但大部分都是小规模交易。 一直以来，强生的强势领域都是血液瘤与自免，2023年，乌司奴单抗年销售首次越过百亿美元大关，古塞奇尤单抗更是在当打之年，合作CAR-T产品西达基奥仑赛则是肿瘤领域冉冉上升的新星。近年来，强生大部分制药领域的收购和引进也都在持续加强这两个领域，例如去年JPM大会上出手20亿美元收购ADC制药公司Ambrx。 神经科学不是强生的强项。2019年上市的抗抑郁鼻喷剂Ketamine是强生神经科学部门的主要品种，2024年前三季度，强生神经科学产品销售额53.4亿美元，远不及肿瘤和自免领域。 这次天价收购背后，预示着强生开发策略将重新向神经科学领域倾斜。 精神类药物不少已经数十年没有更新，存在巨大未被满足的临床需求，尤其在精神障碍类疾病上。大多药物起效慢，症状改善不明显，副作用又大，而新近上市的药品也存在各种局限性。 卢美哌隆独具优势。临床数据显示，卢美哌隆在体重变化、代谢影响和锥体外系症状方面与安慰剂相似，不良反应较轻。而且卢美哌隆无需剂量滴定，只需患者在家口服吃药即可。 实际上，众多跨国药企已经投入到神经科学领域交易中。例如艾伯维87亿美元收购Cerevel，BMS140亿美元收购Karuna，均为大额交易。强生这次天价收购将进一步带动神经科学市场热情。 撰稿丨李傲 编辑丨江芸 贾亭 运营｜山谷 插图｜视觉中国 声明：健识局原创内容，未经许可请勿转载 创新药新年大利好！医保丙类目录要来了 互联网医疗的最后一次进化：蚂蚁集团拿下好大夫 2024第五届论健·年度星榜“年度卓越领军人物”揭晓！