A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain following Laparoscopic Colectomy

开始日期2021-07-20

申办/合作机构

Vivozon Pharmaceutical Co., Ltd.

NCT05764525

/ Completed临床3期

The purpose of this phase 3 study is to evaluate the efficacy and safety of VVZ-149 Injections for the treatment of postoperative pain following laparoscopic colectomy.

开始日期2021-07-19

申办/合作机构

Vivozon Pharmaceutical Co., Ltd.

100 项与 Opiranserin 相关的临床结果

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100 项与 Opiranserin 相关的转化医学

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100 项与 Opiranserin 相关的专利（医药）

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项与 Opiranserin 相关的文献（医药）

2025-02-01·JOURNAL OF CLINICAL ANESTHESIA

Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy

Article

作者: Cho, Sunyoung ; Bahk, Jae-Hyon ; Park, Mi-Hye ; Lee, Ho-Jin ; Kim, Jina ; Oh, Ah-Young ; Sim, Ji-Yeon ; Kim, Duk Kyung ; Park, Insun ; Moon, Young-Jin ; Nedeljkovic, Srdjan S ; Song, Inkyung ; Lee, Sang Rim ; Yoon, Seung Zhoo

STUDY OBJECTIVE:

VVZ-149 is a small molecule that inhibits the glycine transporter type 2 and the serotonin receptor 5-hydroxytryptamine 2 A. In this Phase 3 study, we investigated the efficacy and safety of VVZ-149 as a single-use injectable analgesic for treating moderate to severe postoperative pain after laparoscopic colectomy.

DESIGN:

Randomized, parallel group, double-blind, Phase 3 clinical trial (Trial no. NCT05764525).

SETTING:

5 tertiary referral centers in South Korea.

PATIENTS:

284 patients undergoing laparoscopic colectomy.

INTERVENTIONS:

A continuous 10-h intravenous infusion of VVZ-149 (n = 141) or placebo (n = 143) administered after emergence from anesthesia.

MEASUREMENTS:

Pain intensity was assessed using a numeric rating scale (NRS) from the start of infusion for 48 h. The primary efficacy measure was the Sum of Pain Intensity Difference (SPID) for the first 12 h after the start of drug infusion. Other efficacy measures included SPID at other time points, opioid consumption via on-demand patient-controlled analgesia (PCA) and rescue medication, and proportion of patients who did not require rescue opioids for 48 h post-dose.

MAIN RESULTS:

Pain relief as measured by SPID was significantly improved by 35 % in the VVZ-149 group compared to the placebo group at 6 h (p = 0.0193) and 12 h (p = 0.0047) after the start of infusion. Significantly lower pain intensity scores were observed between 4-10 h in the VVZ-149 group compared to the placebo group (p = 0.0007), reaching mild pain (mean NRS <4) at 8 h. VVZ-149 alleviated pain during the first 12 h post-dose with 30.8 % less opioid consumption and 60.2 % fewer PCA requests when compared with placebo. A higher proportion of patients receiving VVZ-149 were rescue opioid-free during 2-6 h (p = 0.0026) and 6-12 h (p = 0.0024) compared with the placebo group. VVZ-149 administration in post-colectomy patients was generally safe and well tolerated.

CONCLUSIONS:

When compared to placebo, VVZ-149 infusion demonstrated a significant reduction of pain within the first 12 h after surgery with a substantial decrease in opioid use. VVZ-149 rapidly lowers the pain intensity starting at as early as 4 h post-dose, allowing subjects to experience mild pain levels from 8 h through 48 h. Therefore, the analgesic effect of VVZ-149 was shown to effectively relieve pain and reduce opioid use for treating moderate to severe pain in the early postoperative care setting.

REGISTRATION NUMBER:

Trial Number NCT05764525.

2022-02-01·Journal of clinical anesthesia2区 · 医学

Exploratory study of VVZ-149, a novel analgesic molecule, in the affective component of acute postoperative pain after laparoscopic colorectal surgery

2区 · 医学

Article

作者: Zeballos, Jose L ; Ledley, Johanna S ; Correll, Darin J ; Cho, Sunyoung ; Song, Inkyung ; Bai, Xiang ; Bao, Xiaodong ; Lee, Sang Rim ; Zhang, Yi ; Bhandari, Ashish ; Nedeljkovic, Srdjan S

STUDY OBJECTIVE:

VVZ-149 is a small molecule that inhibits the glycine transporter type 2 and the serotonin receptor 5-hydroxytryptamine 2A. In the present study, we investigated the efficacy and safety of VVZ-149 as a single-use injectable analgesic for treating moderate to severe postoperative pain after colorectal surgery.

DESIGN:

Randomized, parallel group, double-blind Phase 2 clinical trial (NCT02489526).

SETTING:

3 academic institutions in the United States.

PATIENTS:

60 patients undergoing laparoscopic colorectal surgery.

INTERVENTIONS:

A continuous 8-h intravenous infusion of VVZ-149 Injections (n = 40) or placebo (n = 20) administered after emergence from anesthesia.

MEASUREMENTS:

The outcome measures included pain intensity (PI), opioid consumption via patient-controlled analgesia (PCA), and rescue dosing provided "as needed". Early rescue dosing with opioids postoperatively was associated with preoperative negative affect (anxiety, depression, and pain catastrophizing), enabling it to be used as an indirect measure of the affective component of pain. Efficacy outcomes were compared between treatment groups based on preoperative negative affect and early rescue dosing of opioids.

MAIN RESULTS:

Postoperative PI was non-significantly lower in patients receiving VVZ-149 compared to those receiving placebo. The VVZ-149 group had a 34.2% reduction in opioid consumption for 24 h post-dose, along with fewer PCA demands. Somnolence and headache was higher in the intervention group. For patients characterized by high levels of preoperative negative affect, the VVZ-149 group experienced a significant pain reduction and 40% less opioid use compared to the placebo group.

CONCLUSIONS:

VVZ-149 resulted in a non-significant reduction of postoperative pain during the first 8 h after surgery. Post hoc analysis indicates that VVZ-149 may benefit patients with negative affect who otherwise have higher postoperative opioid use. REGISTRATION NUMBER: www.clinicaltrials.gov, ID: NCT02489526.

2021-09-08·Pain medicine (Malden, Mass.)3区 · 医学

Role of VVZ-149, a Novel Analgesic Molecule, in the Affective Component of Pain: Results from an Exploratory Proof-of-Concept Study of Postoperative Pain following Laparoscopic and Robotic-Laparoscopic Gastrectomy

3区 · 医学

Article

作者: Cho, Sunyoung ; Kim, Jina ; Song, Inkyung ; Bai, Sun Joon ; Nedeljkovic, Srdjan S ; Lee, Sang Rim ; Lee, Chaewon

Abstract:

Objective:

VVZ-149 is a small molecule that both inhibits the glycine transporter type 2 and the serotonin receptor 5 hydroxytryptamine 2 A. In a randomized, parallel-group, and double-blind trial (NCT02844725), we investigated the analgesic efficacy and safety of VVZ-149 Injections, which is under clinical development as a single-use injectable product for treating moderate to severe postoperative pain.

Methods:

Sixty patients undergoing laparoscopic and robotic-laparoscopic gastrectomy were randomly assigned to receive a 10-hour intravenous infusion of VVZ-149 Injections or placebo, initiated approximately 1 hour before completion of surgical suturing. Major outcomes included pain intensity and opioid consumption via patient-controlled analgesia and rescue analgesia provided “as needed.” The treatment efficacy of VVZ-149 was further examined in a subpopulation requiring early rescue medication, previously associated with the presence of high levels of preoperative negative affect in a prior Phase 2 study (NCT02489526).

Results:

Pain intensity was lower in the VVZ-149 (n = 30) than the placebo group (n = 29), reaching statistical significance at 4 hours post-emergence (P < .05), with a 29.5% reduction in opioid consumption for 24 hours and fewer demands for patient-controlled analgesia. In the rescued subgroup, VVZ-149 further reduced pain intensity (P < .05) with 32.6% less opioid consumption for 24 hours compared to placebo patients.

Conclusions:

VVZ-149 demonstrated effective analgesia with reduced postoperative pain and opioid requirements. Consistent with the results from the previous Phase 2 study, patients with early rescue requirement had greater benefit from VVZ-149, supporting the hypothesis that VVZ-149 may alleviate the affective component of pain and mitigate excessive use of opioids postoperatively.

项与 Opiranserin 相关的新闻（医药）

2025-02-24

·凯莱英Asymchem

【服务赋能】凯莱英一站式服务助力Vivozon非麻醉性止痛药Unafra获韩国MFDS市场授权

近日，Vivozon宣布其非麻醉性止痛药Unafra正式获得韩国MFDS市场授权。这是Vivozon在疼痛管理领域的一个重要里程碑，也是凯莱英医药集团（股票代码：002821.SZ/6821.HK，以下简称“凯莱英”）一站式服务高质效赋能的又一重要成果。 Unafra是一种非麻醉性止痛药，其活性成分为opianserine。它是一种小分子药物，作为5-HT2A拮抗剂和GlyT2抑制剂。Unafra通过抑制大脑中的特定受体来减轻疼痛感，而不会像阿片类药物那样产生依赖性和副作用。它已经被开发用于治疗急性疼痛，并且已经获得了韩国MFDS（食品药品安全部）的市场授权，成为韩国第38种本土研发的新药。 Unafra的药理作用机制包括对2型甘氨酸转运蛋白(GlyT2)和5-羟色胺受体2A(5HT2A)的双重拮抗作用，IC50值分别为0.86和1.3μM。此外，它还对rP2X3受体有拮抗作用，IC50值为0.87μM。在临床研究中，Unafra显示出了良好的安全性和耐受性，并且在治疗术后疼痛方面具有潜在的疗效。在项目合作过程中，凯莱英对其重要的RSM筛选了新的反应条件，并成功进行放大生产，使整体收率提升超过2倍，极大降低了合成成本；同时，通过工艺和设备优化，凯莱英将其主路线主路线某步工艺转化率大幅提升，总收率提升约20%，并顺利完成验证生产工作；此外，在项目申报过程中，凯莱英凭借丰富经验对客户需求给予快速响应和支持，将某项重要资质申请审批时间从原本需要的3个月时间压缩到了1.5个月内，整体推进了该药物的上市进程。 Unafra的开发是疼痛管理领域的一大创新成果，尤其为对于那些寻求非阿片类止痛方案的患者提供了一种新的治疗选择。它的市场授权标志着Vivozon在疼痛管理领域的一个重要里程碑，也是韩国本土研发新药的又一重大成果！凯莱英医药集团再次致以衷心祝贺！未来，公司将以持续进化的一站式服务水平，高质量赋能全球创新药研发与生产，解决更多未满足的临床需求，赋能客户，惠及患者。关于Vivozon Vivozon, Inc.是一家位于韩国首尔的公司，专注于小分子/神经疼痛领域。公司通过使用其独特的离体筛查技术，采用创新方法快速鉴定先导化合物，专门从事小分子药物的发现、开发和商业化，以治疗未满足的中枢神经系统（CNS）医疗需求的患者。Vivozon致力于为患有手术、神经性疼痛、癌症疼痛等疾病的患者开发安全的非阿片类药物下一代止痛药。了解更多公司信息，请访问https://www.vivozon.com/ 关于凯莱英医药集团 ASYMCHEM 凯莱英医药集团（股票代码：002821.SZ/6821.HK）是一家全球领先、技术驱动型的医药外包一站式综合服务商。通过为国内外制药公司、生物技术公司提供药品全生命周期的一站式服务，高效和高质量产品以及服务可加快创新药的临床研究与商业化应用，并降低创新药的研发和生产成本，是创新药物全球产业链中不可或缺的一部分。公司凭借深耕行业超二十五年积累的行业洞察力、成熟的研发生产和服务能力以及良好的声誉，成为全球制药产业可靠的首选合作伙伴。公司依托在小分子CDMO领域积累的服务经验与技术积淀，并积极探索与布局化学大分子药、生物药、制剂、技术输出及合成生物技术等新业务领域。了解更多公司信息，请访问www.asymchem.com

临床研究申请上市

2025-02-18

·PRNewswire

VIVOZON Pharmaceutical Obtains MFDS Approval for UNAFRA Inj.: A Breakthrough Non-Opioid analgesic

SEOUL, South Korea, Feb. 18, 2025 /PRNewswire/ -- On February 17, VIVOZON Pharmaceutical announced that its non-opioid analgesic, UNAFRA Inj., was approved on December 12, 2024. (Active ingredient: Opiranserin HCl) has received approval from the Ministry of Food and Drug Safety (MFDS). With this milestone, UNAFRA Inj. has become the 38th innovative drug in Korea. Continue Reading CI UNAFRA Inj., discovered by using the company's proprietary multi-target drug development platform, is the world's first non-opioid, non-NSAIDS analgesic. It induces analgesic effect by simultaneously inhibiting Glycine Transporter Type 2 (GlyT2) and Serotonin Receptor 2a (5HT2a), thereby blocking pain signals and transmission synergistically across both the central and peripheral nervous systems. Previously, VIVOZON Pharmaceutical confirmed the safety and tolerance of the drug and secured statistical significance for efficacy in a domestic Phase 3 clinical trial and applied for new drug application (NDA) from MFDS in November 2023. The efficacy of the drug was confirmed through the primary endpoint Sum of Pain Intensity Difference over 12 Hours (SPID 12), and secondary endpoints including number of Patient-Controlled Analgesia (PCA) requests and opioid consumption over 12 Hours. This approval marks a breakthrough in the treatment landscape for moderate to severe pain, addressing the high unmet medical needs in a market that previously lacked alternatives to opioid analgesics. UNAFRA Inj. has been hailed as a game changer by the medical community, showing rapid pain relief with fewer side effects and zero risk of addiction compared to existing opioids with severe addiction. The company emphasized that UNAFRA Inj. stands apart from earlier domestically developed drugs, which were primarily "Best-in-Class" or "Me-Too" drugs mimicking existing treatments. In contrast, UNAFRA Inj. is Korea's first "First-in-Class" innovative new drug, demonstrating significant advancements in drug development complexity and originality. Spokesperson from the company states, "We are thrilled to share this groundbreaking approval with our shareholders and investors who have supported us over the years. This milestone will accelerate our plans for product launch and marketing activities." Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床3期申请上市

2025-02-17

·Pharmaindustrial

VIVOZON Pharmaceutical Secures MFDS Approval for UNAFRA Inj.

VIVOZON Pharmaceutical has announced that its non-opioid analgesic, UNAFRA as its active ingredient, Opiranserin HCl has received approval from the Ministry of Food and Drug Safety (MFDS). With this milestone, UNAFRA Inj. has become the 38th innovative drug in Korea. UNAFRA Inj., discovered by using the company's proprietary multi-target drug development platform, is the world's first non-opioid, non-NSAIDS analgesic. It induces analgesic effect by simultaneously inhibiting Glycine Transporter Type 2 (GlyT2) and Serotonin Receptor 2a (5HT2a), thereby blocking pain signals and transmission synergistically across both the central and peripheral nervous systems. Previously, VIVOZON Pharmaceutical confirmed the safety and tolerance of the drug and secured statistical significance for efficacy in a domestic Phase 3 clinical trial and applied for new drug application (NDA) from MFDS in November 2023. The efficacy of the drug was confirmed through the primary endpoint Sum of Pain Intensity Difference over 12 Hours (SPID 12), and secondary endpoints including number of Patient-Controlled Analgesia (PCA) requests and opioid consumption over 12 Hours. This approval marks a breakthrough in the treatment landscape for moderate to severe pain, addressing the high unmet medical needs in a market that previously lacked alternatives to opioid analgesics. UNAFRA Inj. has been hailed as a game changer by the medical community, showing rapid pain relief with fewer side effects and zero risk of addiction compared to existing opioids with severe addiction. The company emphasized that UNAFRA Inj. stands apart from earlier domestically developed drugs, which were primarily 'Best-in-Class' or 'Me-Too' drugs mimicking existing treatments. In contrast, UNAFRA Inj. is Korea's first 'First-in-Class' innovative new drug, demonstrating significant advancements in drug development complexity and originality. Spokesperson from the company stated, "We are thrilled to share this groundbreaking approval with our shareholders and investors who have supported us over the years. This milestone will accelerate our plans for product launch and marketing activities."

上市批准临床3期申请上市

100 项与 Opiranserin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Opiranserin	-	DB16271

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
术后疼痛	韩国	Vivozon Pharmaceutical Co., Ltd.	2024-12-12

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适应症	最高研发状态	国家/地区	公司	日期
急性疼痛	临床3期	美国	Vivozon Pharmaceutical Co., Ltd.	2021-07-19
疼痛	临床1期	-	Vivozon, Inc.	2014-07-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05764525 (CTgov)	临床3期	急性疼痛 \| 术后疼痛	285	VVZ-149 Injections (VVZ-149 Injections)	網蓋鹽鑰網艱繭製艱襯(膚艱膚淵蓋夢繭壓壓鏇) = 餘製衊餘夢鹽廠選選網齋顧鬱窪襯簾簾糧製構 (網願繭餘遞顧鹽遞衊獵, 1.73) 更多	-	2025-02-20
				Placebo (Placebo)	網蓋鹽鑰網艱繭製艱襯(膚艱膚淵蓋夢繭壓壓鏇) = 壓醖鹹夢遞範窪餘願網齋顧鬱窪襯簾簾糧製構 (網願繭餘遞顧鹽遞衊獵, 1.72) 更多
NCT05764525 (Pubmed) 人工标引	临床3期	术后疼痛	284	VVZ-149	鬱鬱鏇淵蓋獵願遞憲選(鑰憲鹽廠製襯窪艱齋築) = significantly improved by 35 % in the VVZ-149 group compared to the placebo group at 6 h (p = 0.0193) and 12 h (p = 0.0047) after the start of infusion. 窪膚遞鹽鏇鏇鬱醖顧餘 (餘膚網範繭觸壓築觸鹹 ) 更多	积极	2024-12-19
				Placebo
NCT02489526 (Pubmed) 人工标引	临床2期	术后疼痛	60	VVZ-149	繭鹹憲選壓鹽窪齋鑰顧(繭憲衊築憲廠築廠鹹憲) = non-significantly lower in patients receiving VVZ-149 compared to those receiving placebo 選窪蓋襯築遞築憲鏇襯 (積獵製築夢膚獵艱醖繭 ) 更多	积极	2021-11-15
				Placebo
NCT02844725 (Pubmed) 人工标引	临床2期	术后疼痛	59	VVZ-149	襯觸顧窪顧遞淵築築糧(廠鏇鏇願觸範蓋艱築製) = reaching statistical significance at 4 hours post-emergence 齋衊衊簾積廠糧簾淵簾 (鏇獵鏇餘膚醖顧網餘觸 ) 更多	积极	2021-09-08
				Placebo