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.
瑞士臨牀階段生物製藥公司NLS製藥有限公司(納斯達克市場代碼：NLSP)(以下簡稱“NLS”或“公司”)今天宣佈，它已經為特發性睡眠過多(IH)患者推出了一項付費命名患者計劃。NLS已經與Caligor Coghlan Pharma Services建立了合作伙伴關係，Caligor Coghlan Pharma Services是一家全球活躍的製藥公司，專門從事命名患者、擴大訪問、早期訪問和同情使用計劃。NPP將提供使用Mazindol ER治療IH的途徑，在某些國家，這種藥物將無法用於這種適應症。IH的NPP本週在英國啟動，預計將在未來幾周和幾個月內擴展到其他國家。
"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首席執行官亞歷克斯·茲懷爾説，經過幾個月的準備，我們很高興能為目前沒有獲得批准的治療方案的特發性高睡眠症患者推出一項NPP。我們對促進IH新療法的監管機構以及醫學專家深表感謝，並期待着迅速努力，使Mazindol ER儘快提供給這一計劃下的患者。
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是一種慢性神經系統疾病，其特徵是過度嗜睡、無法控制的睡眠需求或白天嗜睡，即使夜間睡眠充足或延長，這種嗜睡也會持續至少三個月。在歐洲聯盟(歐盟)，大約每10,000人中就有3人受到感染。這相當於總共約15.6萬人。到今天為止，歐盟還沒有批准用於治療IH的療法。IH患者通常會收到關於改變生活方式的建議，以幫助調整他們的睡眠模式。NLS的Mazindol ER是一種替代治療選擇，歷史上一直被用於治療多種疾病。它正在進行發作性睡病和其他睡眠障礙的臨牀試驗。該NPP將允許醫生在標籤外開出用於治療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，美國食品和藥物管理局(FDA)批准了用於治療IH的Mazindol ER的孤兒藥物名稱(ODD)。此前，Mazindol ER於2022年7月21日在歐洲獲得了IH的ODD。
譯文內容由第三人軟體翻譯。