Sofpironium Bromide

▎药明康德内容团队编辑 Botanix Pharmaceuticals公司今日宣布，美国FDA已经批准Sofdra（sofpironium）凝胶（12.45%）上市，用于治疗9岁以上的儿童和成人原发性腋窝多汗症患者。新闻稿指出，这是FDA批准治疗这一症状的首款新分子实体。 FDA的批准得到两项关键性3期临床试验结果的支持，包括701名原发性腋窝多汗症患者。试验结果显示，约85%患者在使用sofpironium凝胶后病情出现具临床意义的改善。两项3期临床试验均达到了所有主要终点和关键性次要终点。 Sofpironium是一种抗胆碱能/抗毒蕈碱药物，通过与受体结合阻断出汗信号，从而抑制腺体出汗。该疗法设计为使用专有涂抹器将sofpironium以凝胶制剂的形式递送至腋下，使患者避免直接接触手上的药物。 多汗症患者分泌超过调节体温所需的汗液，这是一种对患者生活质量产生深远影响的症状，它可能影响患者的工作生产力、精神健康、个人关系和日常活动。在粉刺和特应性皮炎之后，多汗症是第三大皮肤症状，仅在美国，就有约1000万患者受到原发性腋窝多汗症的困扰。 了解更多FDA获批新药 请点击下图访问我们的小程序 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] FDA approval of Sofdra – the first new drug for primary axillary hyperhidrosis. Retrieved June 20, 2024, from https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

Hyperhidrosis is the third largest dermatology market behind acne and atopic dermatitis, according to Botanix. Everybody sweats, but for the 10 million people in the U.S. living with primary axillary hyperhidrosis, sweating can take on a whole new meaning. The condition is hallmarked by sweating beyond the level necessary to regulate body temperature. Primary axillary hyperhidrosis specifically refers to the underarms and has major effects on quality of life, potentially impacting patients' work productivity, social interactions and emotional well-being. It’s been years since a new treatment hit the market in this condition. With an FDA approval in hand, Botanix hopes its topical gel Sofdra can change the game. The drug won FDA approval to treat primary axillary hyperhidrosis in patients ages 9 and older. It’s the first and only new chemical entity cleared for the condition, Botanix said in a press release. Current treatment options include AbbVie’s Botox injections and different formulations of glycopyrrolate. Many of the marketed therapies aren’t as targeted as Sofdra so they can dry out other fluids, such as tears, saliva and even cause urinary retention, Botanix’s founder and board executive director, Matt Callahan, said in a recent interview. In two phase 3 studies that enrolled a total of 701 patients, the gel helped patients achieve clinically and statistically meaningful improvements from baseline levels in the Gravimetric Sweat Production scale and the Hyperhidrosis Disease Severity Measure-Axillary score, according to the company's release. Reaching the roughly 10 million U.S. patients with primary axillary hyperhidrosis will require a unique commercial approach for Botanix, especially considering that fewer than half of patients have an official diagnosis, according to the company. Bearing in mind the social challenges the condition presents, many patients may be actively searching online to find a treatment, as opposed to visiting the dermatologist’s office, Callahan said. Botanix will reach these patients through a “very strong digital approach” that includes a telemedicine component. “This is kind of one of those areas where people don't like to talk about it much and dermatologists don't seem to know much about it,” Callahan explained. “So we're trying to solve that problem with a telemedicine approach to provide a better service and a better fulfillment option to these patients.” Still, the large patient population makes for a “massive opportunity” for Botanix, the executive said. Sofrda is the Australia-based company’s first commercial product. It will come with a price tag “on par” with other treatments on the market, but the key difference, Callahan said. Prescription wipe Qbrexza has an average retail price of $771, according to GoodRx.   Considering 90% of those with hyperhidrosis also suffer from excessive sweating in other areas of the body, there is “lots of future potential” from a label expansion perspective, Callahan noted. Callahan says Botanix is something of a “hidden gem” on the Australian Stock Exchange, but the drugmaker plans to become “the next big dermatology company in the U.S.," he added. Its U.S. operations are based in Pennsylvania and Arizona, and the company is also working on treatments for acne and rosacea. The approval makes for a “transformative event” for the company as it transitions “from a development stage to a revenue-generating dermatology company,” CEO Howie McKibbon, M.D., added in Botanix's release. The drugmaker will roll out initial doses through an early patient experience program during this year’s third quarter. The wider launch is expected to take off during the fourth quarter.