NLS Pharmaceutics Announces Launch Of Paid For Named Patient Program With Mazindol ER For Idiopathic Hypersomnia, A Serious Sleep Disorder With No Approved Treatment Options In Europe
NLS Pharmaceutics Announces Launch Of Paid For Named Patient Program With Mazindol ER For Idiopathic Hypersomnia, A Serious Sleep Disorder With No Approved Treatment Options In Europe
NLS Pharmaceutics Ltd. (NASDAQ:NLSP), (NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that it has launched a paid for Named Patient Program (NPP) for patients suffering from idiopathic hypersomnia (IH). NLS has partnered with Caligor Coghlan Pharma Services, a globally active pharmaceutical company specializing in named patient, expanded access, early access and compassionate use programs. The NPP will provide access to Mazindol ER for the treatment of IH where this medication would not otherwise be available for this indication in certain countries. The NPP for IH was launched in the United Kingdom this week and is expected to expand into other countries over the coming weeks and months.
瑞士临床阶段生物制药公司NLS制药有限公司(纳斯达克市场代码：NLSP)(以下简称“NLS”或“公司”)今天宣布，它已经为特发性睡眠过多(IH)患者推出了一项付费命名患者计划。NLS已经与Caligor Coghlan Pharma Services建立了合作伙伴关系，Caligor Coghlan Pharma Services是一家全球活跃的制药公司，专门从事命名患者、扩大访问、早期访问和同情使用计划。NPP将提供使用Mazindol ER治疗IH的途径，在某些国家，这种药物将无法用于这种适应症。IH的NPP本周在英国启动，预计将在未来几周和几个月内扩展到其他国家。
"After months of preparation we are excited to launch a NPP for people living with idiopathic hypersomnia who currently have no approved treatment options. We are deeply grateful to the regulatory bodies as well as medical experts who facilitate new therapies for IH, and look forward to working quickly to make Mazindol ER available to patients under this program as soon as possible", said Alex Zwyer, Chief Executive Officer of NLS.
NLS首席执行官亚历克斯·兹怀尔说，经过几个月的准备，我们很高兴能为目前没有获得批准的治疗方案的特发性高睡眠症患者推出一项NPP。我们对促进IH新疗法的监管机构以及医学专家深表感谢，并期待着迅速努力，使Mazindol ER尽快提供给这一计划下的患者。
IH is a chronic, neurological disorder that is characterized by excessive sleepiness, an uncontrollable need to sleep or daytime sleepiness that persists for at least three months even with adequate or prolonged night-time sleep. IH affects approximately three in 10,000 people in the European Union (EU). This is equivalent to a total of around 156,000 people. As of today, no therapies are authorised in the EU for the treatment of IH. Patients with IH usually receive advice on lifestyle changes to help regulate their sleeping pattern. NLS' Mazindol ER is an alternative therapeutic option that has been historically used to treat a number of conditions. It is undergoing clinical trials in narcolepsy and other sleep disorders. This NPP will allow physicians to prescribe Mazindol ER off-label for use in treating IH.
IH是一种慢性神经系统疾病，其特征是过度嗜睡、无法控制的睡眠需求或白天嗜睡，即使夜间睡眠充足或延长，这种嗜睡也会持续至少三个月。在欧洲联盟(欧盟)，大约每10,000人中就有3人受到感染。这相当于总共约15.6万人。到今天为止，欧盟还没有批准用于治疗IH的疗法。IH患者通常会收到关于改变生活方式的建议，以帮助调整他们的睡眠模式。NLS的Mazindol ER是一种替代治疗选择，历史上一直被用于治疗多种疾病。它正在进行发作性睡病和其他睡眠障碍的临床试验。该NPP将允许医生在标签外开出用于治疗IH的Mazindol ER。
On November 2,2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for Mazindol ER for the treatment of IH. Previously, Mazindol ER was granted ODD for IH in Europe on July 21, 2022.
2022年11月2日，美国食品和药物管理局(FDA)批准了用于治疗IH的Mazindol ER的孤儿药物名称(ODD)。此前，Mazindol ER于2022年7月21日在欧洲获得了IH的ODD。
译文内容由第三方软件翻译。