Seasonal Affective Disorder

Pivotal Trial for Improving Overall Function and Quality of Life SALT LAKE CITY--(BUSINESS WIRE)-- PhotoPharmics, Inc. a pioneer in specialized phototherapy for neurodegenerative diseases, alongside the Center for Health + Technology (CHeT) at the University of Rochester Medical Center (URMC), today announced the initiation of a groundbreaking pivotal trial. The "Celeste Light for PD Trial" (found at lightforpd.com) represents a significant stride in Parkinson’s disease (PD) treatment, leveraging innovative Spectramax™ technology through the passive and non-invasive Celeste® phototherapy device. This pivotal trial will assess the efficacy of Celeste®, the company’s FDA Breakthrough phototherapy device to improve non-motor and motor function and quality of life in Parkinson’s disease (PD). The Celeste device builds on the company’s innovative Spectramax™ technology that has been successfully used in previous human research. This 300-patient phototherapy trial will be the largest trial of its kind. Kent Savage, President and CEO of PhotoPharmics, underlined the importance and anticipation surrounding the trial. "After overcoming funding challenges and delays caused by the global pandemic, we are thrilled to launch this trial, which holds immense promise for those affected by Parkinson's Disease," he stated. The trial follows the FDA’s Breakthrough Device Designation for the Celeste® device in April 2020, acknowledging its potential in treating PD. Dan Adams, Chief Science Officer at PhotoPharmics, reflected on the significant outcomes of the previous trials. "Our initial trials demonstrated remarkable improvements in both quality of life and non-motor symptoms for PD patients, offering a new horizon in PD treatment," Adams said. The MDS-UPDRS Parts 1+2 and the PDQ 39 showed very large clinical benefit, indicating substantial improvements in patients' day-to-day function and quality of life. The Celeste phototherapy device is based on the understanding that PD damages the retina and impacts the circadian system and various symptoms such as tremor to sleep, cognition, depression, and fatigue. Targeting photoreceptors in the eye responsible for circadian signaling, Celeste® offers a unique and non-invasive treatment approach. Dr. Ray Dorsey, Professor of Neurology at URMC and lead investigator, emphasized the trial's at-home, telemedicine-based format. "The convenience of assessing patients' progress at home makes this trial particularly relevant and accessible," he noted. This approach allows for broader participation, including individuals in remote locations. The six-month trial will involve 300 participants enjoying the Celeste® device daily during their usual evening activities. This non-invasive therapy complements current medical care, requiring no alteration to existing medical regimes. The telemedicine approach improves access to care by delivering an FDA breakthrough therapy to patients nationwide independent of their proximity to major clinics. The Celeste trial is poised to address the widespread, critical unmet needs such as sleep disturbances, fatigue, depression, anxiety, and cognition for which there are currently no FDA approved therapies. These symptoms are often more debilitating than motor symptoms and can significantly deteriorate the quality of life. “A pivotal trial for medical devices is similar to a phase 3 trial drug trial,” said Dan Adams, chief science officer. “As patients reported in our prior trial, this may be the only treatment that improves functional abilities in PD when administered on top of current medication. We recently presented our new trial design to the FDA with a favorable review.” Participating in the Trial People with Parkinson’s disease and their caregivers may apply to participate in the trial at . Qualified participants will receive up to $500. No additional pills, surgery, or even doctor’s visits are required. The entire study will be in the comfort of the participant’s home with Zoom video interactions with the medical team. Focus of the Trial Current treatments for PD primarily treat motor symptoms, and very few options exist for the debilitating non-motor problems that are also part of the disease. As Parkinson’s progresses, these non-motor issues become even more pronounced and are often the determining factors for quality of life and institutionalization.1 In fact, the Movement Disorders Society has identified these debilitating non-motor problems as a major unmet therapeutic need.2 The LIGHT-PD clinical trial represents a potentially monumental step in PD research and treatment. With its non-invasive approach, broad eligibility criteria, and telemedicine-based design, it stands as a beacon of hope for many. The collaboration between PhotoPharmics and CHeT underscores a commitment to pioneering research and a shared vision of improving the lives of those affected by Parkinson's Disease. About CHeT The Center for Health + Technology (CHeT) is a clinical research organization within the University of Rochester. Their team designs and conducts multi-center clinical trials with collaborators from across the globe to accelerate clinical research and advance the development of therapeutics, benefiting individuals in our community and beyond. Since its inception over three decades ago, CHeT has reshaped the conduct of clinical trials, from incorporating novel technologies into clinical trial design to modeling disease progression. Learn more at . About PhotoPharmics PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007). Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at . 1 Schapira, A., Chaudhuri, K. & Jenner, P. Non-motor features of Parkinson disease. Nat Rev Neurosci 18, 435–450 (2017). 2 Seppi K, Ray Chaudhuri K, Coelho M, Fox SH, Katzenschlager R, Perez Lloret S, Weintraub D, Sampaio C, collaborators of the Parkinson's Disease Update on Non‐Motor Symptoms Study Group on behalf of the Movement Disorders Society Evidence‐Based Medicine Committee, Chahine L, Hametner EM. Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review. Movement Disorders. 2019 Feb;34(2):180-98.

作者 | 可颂来源 | 米内网2023H1中国公立医疗机构终端抗抑郁药市场止跌回升，涨幅近8%，豪森首次登顶榜首，辉瑞跌出前三。01抗抑郁药“一哥”易主TOP20洗牌数据显示，抗抑郁药此前在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端销售额持续攀升，从2013年的超过41亿元增长至2019年的超过90亿元；随后受集采及疫情影响，市场进入调整期，2020年、2021年、2022年分别同比下滑2.35%、0.93%、5.35%；2023年上半年销售额超过45亿元，同比增长7.98%，市场止跌回升。中国公立医疗机构终端抗抑郁药销售情况（单位：万元）从厂家排名上看，江苏豪森药业集团、灵北、山东京卫制药、辉瑞、浙江华海药业依次位列前五。其中，江苏豪森药业集团首次登顶榜首，市场份额从2019年的不足2.96%上升至2023年上半年的8.49%；辉瑞自2013年至2021年均为抗抑郁药市场“销冠”厂家，受集采影响市场份额持续萎缩，2022年排名下滑至第三，2023年上半年跌出前三。2023H1中国公立医疗机构终端抗抑郁药TOP5厂家抗抑郁药产品TOP20中，草酸艾司西酞普兰片自2015年以来持续稳居榜首，以超过9亿元的销售额与第二名拉开差距；米氮平片、阿戈美拉汀片、盐酸舍曲林片分别位列第二、第三、第四，销售额均超过4亿元。2023H1中国公立医疗机构终端抗抑郁药产品TOP209个产品销售额涨逾10%，盐酸米那普仑片狂飙11857.89%、盐酸米安色林片大涨26.01%、阿戈美拉汀片大涨24.36%。5个产品销售额出现负增长，具体为草酸艾司西酞普兰片、盐酸帕罗西汀片、盐酸文拉法辛缓释片、盐酸氟西汀分散片、盐酸文拉法辛胶囊，其中盐酸文拉法辛胶囊大跌18.41%。抗抑郁药品牌TOP20中，15个品牌2023年上半年销售额超过1亿元，豪森药业的阿戈美拉汀片首次登顶榜首，山东京卫制药的草酸艾司西酞普兰片位列第二；2个品种草酸艾司西酞普兰片、米氮平片各有4家企业上榜；国产品牌有12个，进口品牌有8个，辉瑞、华海药业各有2个品牌上榜。2023H1中国公立医疗机构终端抗抑郁药品牌TOP2002石药斩获首仿复星、康弘、华海领跑过评榜在过去的2023年，国内共有18家企业的抗抑郁药（涉及13个品种）获批生产，并视同通过一致性评价。其中，石药集团的琥珀酸去甲文拉法辛缓释片、安徽新世纪药业的盐酸氟西汀口服溶液为国内首仿；3个品种为国产第2家，包括四川科瑞德制药的盐酸米那普仑片、浙江国镜药业的草酸艾司西酞普兰口服溶液、江西施美药业的盐酸氟西汀分散片。2023年获批上市的国产抗抑郁药截至目前，抗抑郁药已有26个品种通过或视同通过一致性评价。其中，复星医药（含重庆药友、洞庭药业）以5个过评品种领跑，康弘药业、华海药业各有4个品种过评，科伦药业、石药集团、福元医药、上海医药等4家企业各有3个品种过评。抗抑郁药过评情况7个品种过评企业达5家及以上，草酸艾司西酞普兰片过评企业多达15家，作为抗抑郁药市场销售TOP1产品，2023年该药再有3家企业获得批文，市场竞争日趋激烈；此外，盐酸度洛西汀肠溶胶囊有12家企业过评，氢溴酸伏硫西汀片有9家企业过评，盐酸舍曲林片有8家企业过评……7个品种为独家过评，包括莹硕生技的盐酸米那普仑胶囊、石药集团的琥珀酸去甲文拉法辛缓释片、科伦药业的氢溴酸西酞普兰胶囊、上海医药的盐酸度洛西汀肠溶片、丽珠集团的马来酸氟伏沙明片、安徽新世纪药业的盐酸氟西汀口服溶液、豪森药业的阿戈美拉汀片。039款抗抑郁药已纳入集采2大品种备战在已落地执行的八批九轮化药集采中，抗抑郁药合计有9个通用名药品被纳入，其中7个为口服常释剂型，2个为缓释控释剂型。抗抑郁药国家集采品种除去已纳入国家集采的品种，目前抗抑郁药还有2个品种满足集采门槛，符合申报资格企业数达5家及以上，具体为伏硫西汀口服常释剂型、安非他酮缓释控释剂型。伏硫西汀是一款多靶点作用机制的新型抗抑郁剂，同时具有5-HT转运体(SERT)抑制作用、5-羟色胺(5-HT1A)受体激动作用以及5-HT3受体拮抗作用，尚未进入国家医保药品目录。数据显示，近年来伏硫西汀在中国公立医疗机构终端市场持续扩容，2021年突破1亿元，2022年、2023年上半年分别同比增长13.61%、6.46%。中国公立医疗机构终端伏硫西汀销售情况（单位：万元）1月16日，石四药公告称，其以仿制4类报产的氢溴酸伏硫西汀片获批生产并视同过评。目前，氢溴酸伏硫西汀片已有9家企业过评，包括正大天晴、豪森药业、石药集团、倍特药业、扬子江药业、石四药等。该药原为第八批拟集采品种，后在正式目录中被剔除，会否纳入第十批集采值得关注。伏硫西汀口服常释剂型过评企业盐酸安非他酮缓释片适用于治疗中重度抑郁症以及季节性情感障碍。数据显示，2022年中国公立医疗机构终端安非他酮缓释控释剂型销售额超过7000万元，同比增长超27%。目前，安非他酮缓释控释剂型已有5家企业过评，包括人福医药、普洛药业、迪沙药业、宣泰医药、安必生制药。END医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入

精彩内容近日，慧谷医药的盐酸文拉法辛缓释片获批上市，为国产第4家。米内网数据显示，2023H1中国公立医疗机构终端抗抑郁药市场止跌回升，涨幅近8%；豪森首次登顶榜首，辉瑞跌出前三；产品TOP20草酸艾司西酞普兰片蝉联榜一，品牌TOP20豪森的阿戈美拉汀片夺冠。26个抗抑郁药品种已过评，9个通用名药品已纳入国采，2个药品备战第十批集采。抗抑郁药“一哥”易主！TOP20洗牌米内网数据显示，抗抑郁药此前在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端销售额持续攀升，从2013年的超过41亿元增长至2019年的超过90亿元；随后受集采及疫情影响，市场进入调整期，2020年、2021年、2022年分别同比下滑2.35%、0.93%、5.35%；2023年上半年销售额超过45亿元，同比增长7.98%，市场止跌回升。中国公立医疗机构终端抗抑郁药销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局从厂家排名上看，江苏豪森药业集团、灵北、山东京卫制药、辉瑞、浙江华海药业依次位列前五。其中，江苏豪森药业集团首次登顶榜首，公司市场份额从2019年的不足2.96%上升至2023年上半年的8.49%；辉瑞自2013年至2021年均为抗抑郁药市场“销冠”厂家，受集采影响市场份额持续萎缩，2022年排名下滑至第三，2023年上半年跌出前三。2023H1中国公立医疗机构终端抗抑郁药TOP5厂家来源：米内网中国公立医疗机构药品终端竞争格局抗抑郁药产品TOP20中，草酸艾司西酞普兰片自2015年以来持续稳居榜首，以超过9亿元的销售额与第二名拉开差距；米氮平片、阿戈美拉汀片、盐酸舍曲林片分别位列第二、第三、第四，销售额均超过4亿元。2023H1中国公立医疗机构终端抗抑郁药产品TOP20来源：米内网中国公立医疗机构药品终端竞争格局9个产品销售额涨逾10%，盐酸米那普仑片狂飙11857.89%、盐酸米安色林片大涨26.01%、阿戈美拉汀片大涨24.36%。5个产品销售额出现负增长，具体为草酸艾司西酞普兰片、盐酸帕罗西汀片、盐酸文拉法辛缓释片、盐酸氟西汀分散片、盐酸文拉法辛胶囊，其中盐酸文拉法辛胶囊大跌18.41%。抗抑郁药品牌TOP20中，15个品牌2023年上半年销售额超过1亿元，豪森药业的阿戈美拉汀片首次登顶榜首，山东京卫制药的草酸艾司西酞普兰片位列第二；2个品种草酸艾司西酞普兰片、米氮平片各有4家企业上榜；国产品牌有12个，进口品牌有8个，辉瑞、华海药业各有2个品牌上榜。2023H1中国公立医疗机构终端抗抑郁药品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局石药斩获首仿！复星、康弘、华海领跑过评榜在过去的2023年，国内共有18家企业的抗抑郁药（涉及13个品种）获批生产，并视同通过一致性评价。其中，石药集团的琥珀酸去甲文拉法辛缓释片、安徽新世纪药业的盐酸氟西汀口服溶液为国内首仿；3个品种为国产第2家，包括四川科瑞德制药的盐酸米那普仑片、浙江国镜药业的草酸艾司西酞普兰口服溶液、江西施美药业的盐酸氟西汀分散片。2023年获批上市的国产抗抑郁药截至目前，抗抑郁药已有26个品种通过或视同通过一致性评价。其中，复星医药（含重庆药友、洞庭药业）以5个过评品种领跑，康弘药业、华海药业各有4个品种过评，科伦药业、石药集团、福元医药、上海医药等4家企业各有3个品种过评。抗抑郁药过评情况7个品种过评企业达5家及以上，草酸艾司西酞普兰片过评企业多达15家，作为抗抑郁药市场销售TOP1产品，2023年该药再有3家企业获得批文，市场竞争日趋激烈；此外，盐酸度洛西汀肠溶胶囊有12家企业过评，氢溴酸伏硫西汀片有9家企业过评，盐酸舍曲林片有8家企业过评……7个品种为独家过评，包括莹硕生技的盐酸米那普仑胶囊、石药集团的琥珀酸去甲文拉法辛缓释片、科伦药业的氢溴酸西酞普兰胶囊、上海医药的盐酸度洛西汀肠溶片、丽珠集团的马来酸氟伏沙明片、安徽新世纪药业的盐酸氟西汀口服溶液、豪森药业的阿戈美拉汀片。9款抗抑郁药已纳入集采，2大品种备战在已落地执行的八批九轮化药集采中，抗抑郁药合计有9个通用名药品被纳入，其中7个为口服常释剂型，2个为缓释控释剂型。抗抑郁药国家集采品种除去已纳入国家集采的品种，目前抗抑郁药还有2个品种满足集采门槛，符合申报资格企业数达5家及以上，具体为伏硫西汀口服常释剂型、安非他酮缓释控释剂型。伏硫西汀是一款多靶点作用机制的新型抗抑郁剂，同时具有5-HT转运体(SERT)抑制作用、5-羟色胺(5-HT1A)受体激动作用以及5-HT3受体拮抗作用，尚未进入国家医保药品目录。米内网数据显示，近年来伏硫西汀在中国公立医疗机构终端市场持续扩容，2021年突破1亿元，2022年、2023年上半年分别同比增长13.61%、6.46%。中国公立医疗机构终端伏硫西汀销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局1月16日，石四药公告称，公司以仿制4类报产的氢溴酸伏硫西汀片获批生产并视同过评。目前，氢溴酸伏硫西汀片已有9家企业过评，包括正大天晴、豪森药业、石药集团、倍特药业、扬子江药业、石四药等。该药原为第八批拟集采品种，后在正式目录中被剔除，会否纳入第十批集采值得关注。伏硫西汀口服常释剂型过评企业来源：米内网一致性评价进度数据库盐酸安非他酮缓释片适用于治疗中重度抑郁症以及季节性情感障碍。米内网数据显示，2022年中国公立医疗机构终端安非他酮缓释控释剂型销售额超过7000万元，同比增长超27%。目前，安非他酮缓释控释剂型已有5家企业过评，包括人福医药、普洛药业、迪沙药业、宣泰医药、安必生制药。数据来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦