A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.

开始日期2026-01-01

申办/合作机构

RVL Pharmaceuticals, Inc.

NCT03565887 / Completed临床3期

A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis

Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.

开始日期2018-06-28

申办/合作机构

RVL Pharmaceuticals, Inc.

NCT03536949 / Completed临床3期

A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety of RVL-1201 in the Treatment of Acquired Blepharoptosis (Study RVL-1201-203)

Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.

开始日期2018-06-20

申办/合作机构

RVL Pharmaceuticals, Inc.

100 项与 RVL Pharmaceuticals, Inc. 相关的临床结果

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0 项与 RVL Pharmaceuticals, Inc. 相关的专利（医药）

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项与 RVL Pharmaceuticals, Inc. 相关的文献（医药）

2022-11-02·Brain communications

Arbaclofen extended-release tablets for spasticity in multiple sclerosis: randomized, controlled clinical trial

Article

作者: deVries, Tina ; Kantor, Daniel ; Jaros, Mark ; Hunter, Samuel ; Okuda, Darin T

Abstract:

Baclofen, a racemic GABA-B (GABAB) receptor agonist, is commonly used for the management of multiple sclerosis-related spasticity but is associated with frequent dosing and poor tolerability. Arbaclofen, the active R-enantiomer of baclofen, exhibits 100- to 1000-fold greater specificity for the GABAB receptor compared with the S-enantiomer and ∼5-fold greater potency compared with racemic baclofen. Arbaclofen extended-release tablets have a dosing interval of 12 hours and have shown a favourable safety and efficacy profile in early-phase clinical development. The current Phase 3 study was designed to evaluate the efficacy and safety of arbaclofen extended-release tablets in patients with multiple sclerosis-related spasticity. In this multicentre, double-blind, placebo-controlled study, adults with multiple sclerosis-related spasticity were randomized to arbaclofen extended-release 40 mg/day, arbaclofen extended-release 80 mg/day or placebo for 12 weeks. The co-primary end-points were the change from baseline to Week 12 in the Total Numeric-transformed Modified Ashworth Scale in the Most Affected Limb score and the Clinical Global Impression of Change score. A hierarchical testing procedure was used to evaluate the co-primary end-points; analyses for the 80 mg/day group were considered inferential only if the arbaclofen extended-release 40 mg/day and placebo groups demonstrated a statistically significant difference (P ≤ 0.05) for both end-points. Five hundred thirty-six patients were included in the study. At Week 12, the least squares mean change from baseline in Total Numeric-transformed Modified Ashworth Scale in the Most Affected Limb score was −1.67 (95% confidence interval: −1.97 to −1.36) and −1.28 (95% confidence interval: −1.57 to −0.99) in the arbaclofen extended-release 40 mg/day and placebo groups, respectively (least squares mean difference: −0.39; P < 0.048). Improvements were seen in the mean Clinical Global Impression of Change scores for both the arbaclofen extended-release 40 mg/day and placebo groups; however, no statistically significant difference was observed between them (least squares mean difference: −0.10; P = 0.43). Most adverse events were of mild-moderate severity. Arbaclofen extended-release 40 mg/day for 12 weeks significantly reduced multiple sclerosis-related spasticity compared with placebo and was safe and well tolerated over the 12-week treatment period. Although arbaclofen extended-release 40 mg/day improved Clinical Global Impression of Change scores, a significant difference from placebo was not observed.

项与 RVL Pharmaceuticals, Inc. 相关的新闻（医药）

2024-10-28

·参天公司

治疗获得性上睑下垂的STN1013800滴眼液中国lll期临床试验完成首例患者入组

►►► 2024年10月28日，上海 — 参天公司今天宣布，用于治疗获得性上睑下垂的STN1013800滴眼液（盐酸羟甲唑啉滴眼液）中国III期临床试验完成了首例患者入组，标志着国内获得性上睑下垂治疗领域迎来了重要进展。STN1013800滴眼液的成功研发将为获得性上睑下垂的患者提供新的治疗选择，填补国内药物治疗上睑下垂的空白。 STN1013800滴眼液是一种创新的专用于治疗获得性上睑下垂的药物，该药物通过直接作用于提升上眼睑的肌肉，使肌肉收缩和上睑提升从而改善患者上睑下垂的程度。本项III期临床试验由复旦大学附属眼耳鼻喉科医院孙兴怀教授主持，旨在评估 STN1013800滴眼液治疗获得性上睑下垂患者的有效性和安全性。上睑下垂主要表现为单侧或双侧上眼睑的异常下垂，分为先天性和获得性。获得性上睑下垂存在许多病因，其中腱膜性原因最为常见，主要是由于提肌腱膜的退行性改变或白内障手术、晶状体置换术期间腱膜拉伸或破裂，或者长期佩戴软硬接触镜所致[1,2]。获得性上睑下垂患者可能会报告视物模糊和上方视野缩小，这可能干扰患者的日常生活活动，并会导致生活质量下降。该疾病的治疗，一般以手术为主，但也有患者在确诊后无法接受手术，日常生活障碍未得到改善。目前FDA批准的用于治疗该疾病的药物为Upneeq®。2020年7月，参天制药与美国RVL Pharmaceuticals, Inc.达成合作，获得Upneeq®在日本，中国和其他亚洲国家以及欧洲、中东和非洲国家开发，注册和销售的独家许可[3]，该药物临床试验阶段的代号为STN1013800滴眼液。本项III期临床试验的主要研究者，复旦大学附属眼耳鼻喉科医院孙兴怀教授表示： STN1013800滴眼液的出现有望改善获得性上睑下垂患者的生活质量，其研发和临床试验意义深远，填补了中国在治疗获得性上睑下垂药物方面的空白，将为众多深受该病症困扰的患者带来新的希望。向宇博士参天公司中国区总裁我们非常高兴STN1013800滴眼液在临床试验阶段迈出了重要一步，这也是公司在眼科治疗领域不断探索和创新的里程碑。我们将继续努力，快速推进STN1013800滴眼液的临床研究和获批上市，惠及更多上睑下垂的患者。参天将持续研发和引进创新的解决方案，让更多人享受视觉所带来的美好生活。 END 参考： [1] W A van den Bosch, H G Lemij. Blepharoptosis induced by prolonged hard contact lens wear. Ophthalmology 1992;99(12):1759-65. [2] Reddy AK, Foroozan R, Arat YO, Edmond JC, Yen MT. Ptosis in young soft contact lens wearers. Ophthalmology. 2007 Dec;114(12):2370. [3] 参天公司和Osmotica制药旗下的RVL制药签约RVL-1201独家开发销售协议 | 参天公司 (santen-china.com.cn) 关于参天作为一家专注于视觉健康的公司，参天致力于通过为全球的患者、消费者以及医疗人士提供有价值的产品和服务，以实现参天的世界愿景“Happiness with Vision”。自创立之日起拥有超过130年的历史，公司始终坚持「天機に参与する」（意思是：“参悟天地万物之规律，为增进人类健康做贡献”）这一核心理念，致力于维护和改善人们的视觉健康。参天主要从事眼科药品的研发、生产、销售和推广活动，为全球60多个国家和地区约超过5000万人提供视觉健康的支持。公司的使命是利用我们在眼科医疗领域的专业知识，从患者的角度出发，提供各种产品和服务，持续不断地在眼部疾病预防、诊断和治疗等方面为患者和社会提供重要的价值。为了让更多的患者过上幸福美满的生活，参天致力于实现世界愿景“Happiness with Vision”—“通过创造最佳的视觉体验，让每个人拥有最幸福的生活”。如需了解更多信息，请访问参天公司的网站：http://www.santen-china.com.cn

临床3期申请上市

2023-11-27

·GlobeNewswire-Health Care

RVL Completes Financial Restructuring

Athyrium Provides Capital to Support Long-Term Growth and Exchanges Outstanding Debt into Equity of Certain Reorganized Entities RVL Pharmaceuticals plc Ordinary Shares Expected to be Cancelled in 2024 BRIDGEWATER, N.J., Nov. 27, 2023 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals, Inc. (“RVL” or the “Company”), a specialty pharmaceutical company focused on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or droopy eyelids, in adults, today announced that it and its wholly-owned U.S. operating subsidiary RVL Pharmacy, LLC (collectively, the “RVL Subsidiaries”), successfully emerged from their Chapter 11 cases on November 22, 2023 following the confirmation by the United States Bankruptcy Court for the District of Delaware of their Plan of Reorganization (“Plan”) on November 20, 2023. RevitaLid Pharmaceutical Corp., previously the direct parent company of RVL Pharmaceuticals, Inc, concurrently emerged from its Chapter 11 case, though will be wound down under the Plan. “Upon emergence, the RVL Subsidiaries are well-positioned to invest in UPNEEQ, drive their strategic initiatives, and continue to deliver high-quality, innovative ocular and aesthetic solutions for patients and healthcare partners,” said Brian Markison, Chief Executive Officer of the Company. The Plan was unanimously supported by the RVL Subsidiaries’ sole secured lender (funds managed by Athyrium Capital Management, LP (“Athyrium”)) and other key stakeholders. The Company will continue to operate and be supported as a privately held company under the ownership of Athyrium. It is expected the wind-down of the Company’s former public parent company, RVL Pharmaceuticals plc, and its subsidiaries other than the RVL Subsidiaries will promptly commence, and RVL Pharmaceuticals plc’s public equity is expected to be cancelled upon completion of its wind-down during 2024, resulting in no recovery to public shareholders. About the Company RVL Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or low-lying eyelid, in adults. UPNEEQ is the first non-surgical treatment option approved by the FDA for acquired blepharoptosis. For more information, please visit the Company’s website at www.rvlpharma.com. IMPORTANT SAFETY INFORMATION INDICATION UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, is indicated for the treatment of acquired blepharoptosis in adults. WARNINGS AND PRECAUTIONS Ptosis Association: Ptosis may be associated with neurologic or orbital diseases such as stroke, cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection, and orbital masses. Consider these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.Cardiovascular Impact: Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.Use with Caution: Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.Glaucoma Risk: UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.Container Safety: Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution. ADVERSE REACTIONS Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ include punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation, and headache. DRUG INTERACTIONS Blood Pressure: Alpha-adrenergic agonists, as a class, may impact blood pressure. Exercise caution when using drugs such as beta-blockers, anti-hypertensives, and/or cardiac glycosides.Metabolism: Caution is advised in patients taking monoamine oxidase inhibitors, which can affect the metabolism and uptake of circulating amines. For inquiries, please contact: Brian Markisonbrianmarkison@rvlpharma.com

2021-11-15

·BioSpace

Osmotica Pharmaceuticals plc to Present at Jefferies London Virtual Healthcare Conference 2021

BRIDGEWATER, N.J., Nov. 15, 2021 (GLOBE NEWSWIRE) -Osmotica Pharmaceutical (Nasdaq: OSMT) (“Osmotica” or the “Company”), a specialty pharmaceutical company, announced today that Brian Markison, Chief Executive Officer, James “JD” Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will present at the Jefferies London Virtual Healthcare Conference 2021 as follows: Date: Thursday, November 18, 2021 On Demand Time: 8:00AM GMT (3:00AM ET) Webcast: The presentation will be webcast on-demand and available for 30 days thereafter using the link provided above and via the Company’s website at under the “Investor & News” section. About Osmotica Pharmaceuticals plc Osmotica Pharmaceuticals plc (Nasdaq: OSMT) is a specialty pharmaceutical company focused on the development and commercialization of products that target markets with underserved patient populations. RVL Pharmaceuticals, Inc. is the Company’s ophthalmic subsidiary supporting UPNEEQ®. Osmotica has operations in the United States and Hungary. Investor and Media Relations for Osmotica Pharmaceuticals plc Lisa M. Wilson In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com

100 项与 RVL Pharmaceuticals, Inc. 相关的药物交易

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100 项与 RVL Pharmaceuticals, Inc. 相关的转化医学

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