Delving into the Latest Updates on Epinastine Hydrochloride with Synapse

主要研究目的：以长春海悦药业股份有限公司生产的盐酸依匹斯汀片为受试制剂，以Nippon Boehringer Ingelheim Co., Ltd.持证的盐酸依匹斯汀片（商品名：Alesion，20 mg）为参比制剂，通过单中心、随机、开放、单次给药、两序列、两周期、双交叉临床研究来评价两种制剂在空腹和餐后条件下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study was to use Epinastine Hydrochloride Tablets produced by Changchun Haiyue Pharmaceutical Co., Ltd. as the test preparation and Epinastine Hydrochloride Tablets (trade name: Alesion, 20 mg) certified by Nippon Boehringer Ingelheim Co., Ltd. as the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed conditions through a single-center, randomized, open, single-dose, two-sequence, two-period, double-crossover clinical study. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date07 Nov 2024

Sponsor / Collaborator

Changchun Haiyue Pharmaceutical Co., Ltd

CTR20234212

/ CompletedPhase 3

0.1%STN1011403滴眼液治疗过敏性结膜炎的多中心随机评价者盲态阳性对照试验

[Translation] A multicenter randomized evaluator-blind positive controlled trial of 0.1% STN1011403 eye drops in the treatment of allergic conjunctivitis

以中国过敏性结膜炎患者为对象，验证0.1% STN1011403 滴眼液的有效性非劣于Alesion® LX 滴眼液0.1%以及0.1%盐酸奥洛他定滴眼液，并确认安全性。

[Translation]

The efficacy of 0.1% STN1011403 eye drops was verified to be non-inferior to Alesion® LX eye drops 0.1% and 0.1% olopatadine hydrochloride eye drops in Chinese patients with allergic conjunctivitis, and the safety was confirmed.

Start Date05 Mar 2024

Sponsor / Collaborator

Santen Pharmaceutical (China) Co. Ltd.

CTR20231572

/ CompletedPhase 3

0.05%盐酸依匹斯汀滴眼液治疗中国过敏性结膜炎患者的有效性和安全性的随机、双盲、阳性药平行对照、多中心临床研究

[Translation] A randomized, double-blind, positive-drug parallel-controlled, multicenter clinical study on the efficacy and safety of 0.05% epinastine hydrochloride eye drops in the treatment of allergic conjunctivitis in Chinese patients

主要目的：以富马酸依美斯汀滴眼液为对照，评价0.05%盐酸依匹斯汀滴眼液治疗过敏性结膜炎的有效性。次要目的：评价0.05%盐酸依匹斯汀滴眼液治疗过敏性结膜炎的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of 0.05% epinastine hydrochloride eye drops in the treatment of allergic conjunctivitis, using emedastine fumarate eye drops as a control. Secondary objective: To evaluate the safety of 0.05% epinastine hydrochloride eye drops in the treatment of allergic conjunctivitis.

Start Date22 May 2023

Sponsor / Collaborator

Runer Ophthalmic Drugs (Guangzhou) Co., Ltd.

100 Clinical Results associated with Epinastine Hydrochloride

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100 Translational Medicine associated with Epinastine Hydrochloride

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100 Patents (Medical) associated with Epinastine Hydrochloride

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216

Literatures (Medical) associated with Epinastine Hydrochloride

22 Nov 2024·Cureus

Efficacy of Epinastine Eyelid Cream in Pediatric Vernal Keratoconjunctivitis: A Case Report

Article

Author: Hashida, Noriyasu ; Mamoto, Yukinori ; Shiozaki, Daiki ; Hirose, Rina

Allergic conjunctivitis (AC) is characterized by inflammatory responses in the conjunctiva and is often complicated by atopic dermatitis and mechanical irritation. Vernal keratoconjunctivitis (VKC), a severe subtype of AC, presents unique challenges in its diagnosis and management, particularly in pediatric patients. This case report describes an eight-year-old girl with VKC who exhibited poor adherence to a prescribed regimen of 0.05% epinastine ophthalmic solution and corticosteroid eye drops, resulting in persistent symptoms. Despite initial treatment, the patient's condition included giant papillae and thickened tarsal conjunctivae that were resistant to standard therapies. Upon transitioning to 0.5% epinastine eyelid cream, the patient showed improved adherence and partial symptom resolution. However, new limbal lesions, including Horner-Trantas dots, were observed following the cessation of steroid therapy. The reintroduction of steroids led to significant improvements in conjunctival lesions and complete resolution of limbal gelatinous hyperplasia. This case underscores the potential of epinastine eyelid cream in managing VKC, particularly in patients with adherence issues, and highlights the need for careful monitoring and combination therapy in severe cases. Further studies are needed to evaluate the long-term efficacy and safety of epinastine eyelid cream. However, once-daily application of eyelid cream may serve as a viable treatment and management option for pediatric patients with VKC.

01 Nov 2024·Japanese Journal of Ophthalmology

Safety and efficacy of a novel 0.5% epinastine topical eyelid cream in allergic conjunctivitis: a phase 3 trial

Article

Author: Fujishima, Hiroshi ; Shoji, Jun

AbstractPurposeThe high prevalence of allergic conjunctivitis in Japan necessitates novel, easy-to-use treatment options for prophylactic use. We evaluated the safety and efficacy of a newly-developed 0.5% epinastine topical eyelid cream to prevent the development of allergic conjunctivitis.Study designThis was a phase 3, single-centre, double-masked, intra-patient randomised trial in asymptomatic adults (aged 20–65 years) with seasonal allergic conjunctivitis in Japan.MethodsThe left and right eyes of eligible patients were randomised to receive a topical application of either 0.5% epinastine cream (~ 30 mg per dose) to one eye or placebo cream to the other (on the outer skin of the upper and lower eyelids) after a conjunctival antigen challenge (CAC) test. Symptom severity was assessed up to 24 h post-treatment. Primary efficacy endpoints were mean ocular itching and conjunctival hyperaemia severity scores in each eye; safety endpoints included adverse events (AEs) and adverse drug reaction (ADRs).ResultsIn total, 30 patients (60 eyes) were included in the study. The 0.5% epinastine topical eyelid cream reduced mean ocular itching scores (difference in least squares means ± standard error, − 1.12 ± 0.214; p < 0.0001) and mean conjunctival hyperaemia scores (− 0.54 ± 0.197; p = 0.0097) 24 h after treatment versus placebo. The 0.5% epinastine topical eyelid cream was well tolerated, with no AEs or ADRs reported.ConclusionWith its novel route of administration, 0.5% epinastine topical eyelid cream may be considered a unique, easy-to-use, once-daily treatment option to prevent the onset of seasonal allergic conjunctivitis.

01 Aug 2024·Hospital Pharmacy

Cost-effectiveness Analysis of Second-Generation Antihistamine 1 Receptor Blockers and Japanese Kampo Shoseiryuto for Treating Perennial Allergic Rhinitis in Outpatient Settings in Japan

Article

Author: Kashiwabara, Masami ; Egawa, Kei ; Nakagawa, Naoto ; Sasaki, Ayaka

Objectives: Perennial allergic rhinitis (PAR) is common in Japan. Second-generation antihistamines (SGAs) are commonly used for its treatment; however, it remains unclear which SGA is the most cost-effective. Additionally, the pharmacoeconomics of Japanese Kampo shoseiryuto (which was traditionally prescribed to treat PAR in Japan) remains poorly understood. In this study, we aimed to investigate the effectiveness of various SGAs and shoseiryuto for the treatment of PAR in Japanese outpatients, from the healthcare payer’s perspective. Methods: The most cost- and clinically effective SGAs were determined from a list of 6 SGAs (bepotastine, 10 mg; cetirizine, 10 mg; ebastine, 10 mg; epinastine, 20 mg; loratadine, 10 mg; and olopatadine, 5 mg) together with shoseiryuto, using the overall improvement rate through a model-based analysis. The time horizon was 28 days. Costs were determined based on the Medical Fee Index in 2020. Deterministic and probabilistic sensitivity analyses were conducted to address the uncertainty of the base-case results. Results: Overall, bepotastine (10 mg) and ebastine (10 mg) were cost-effective. Shoseiryuto was less cost-effective than ebastine (10 mg) (dominated). Ebastine (10 mg) was the most cost-effective option based on deterministic and probabilistic sensitivity analyses. Conclusions: Ebastine (10 mg) was the most cost-effective treatment strategy for PAR among the agents evaluated in this study. This insight could aid in establishing an appropriate formulary for treating PAR in hospitals and communities.

100 Deals associated with Epinastine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D01713	Epinastine Hydrochloride	R06AX24 S01GX10	DB00751

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Conjunctivitis, Allergic	JP	Santen Pharmaceutical Co., Ltd.	20 Sep 2013
Seasonal allergic conjunctivitis	SE	Allergan Pharmaceuticals Ireland ULC	04 Mar 2003
Psoriasis	CN	Nippon Boehringer Ingelheim Co., Ltd.	16 Jun 2000
Asthma	JP	Nippon Boehringer Ingelheim Co., Ltd.	01 Apr 1994
Dermatitis	JP	Nippon Boehringer Ingelheim Co., Ltd.	01 Apr 1994
Eczema	JP	Nippon Boehringer Ingelheim Co., Ltd.	01 Apr 1994
Prurigo	JP	Nippon Boehringer Ingelheim Co., Ltd.	01 Apr 1994
Pruritus	JP	Nippon Boehringer Ingelheim Co., Ltd.	01 Apr 1994
Rhinitis, Allergic	JP	Nippon Boehringer Ingelheim Co., Ltd.	01 Apr 1994
Urticaria	JP	Nippon Boehringer Ingelheim Co., Ltd.	01 Apr 1994

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Conjunctivitis, Allergic	Phase 3	CN	Runer Ophthalmic Drugs (Guangzhou) Co., Ltd.	22 May 2023
Seasonal allergic conjunctivitis	Phase 3	CN	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	10 Mar 2023
Rhinitis, Allergic, Seasonal	Phase 2	-	Merck Sharp & Dohme Corp.	18 Dec 2007
Dermatitis, Atopic	Phase 2	-	Boehringer Ingelheim GmbH	01 Jun 2001
Rhinitis, Allergic, Perennial	Phase 2	-	Boehringer Ingelheim GmbH	01 May 2000

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Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01363713 (CTgov)	Phase 3	Conjunctivitis, Allergic	130	DE-114	yullqdwqrl(cdcifogvqj) = cxkzfikeqm bvlrwfkrtz (bhwqbntcbn, mjrwnngxdu - ivxgykwrby) View more	-	23 Sep 2014
NCT00534794 (CTgov)	Phase 4	Conjunctivitis, Allergic	79	Elestat (Elestat)	ealoxiaroo(evufbwelkb) = ljzoekdpif ybusjtgwro (fnlbwxbetk, uzgilyaeeq - qotivkwthf) View more	-	27 May 2009
NCT00534794 (CTgov)	Phase 4	Conjunctivitis, Allergic	79	Pataday (Pataday)	ealoxiaroo(evufbwelkb) = stmrophxjr ybusjtgwro (fnlbwxbetk, xhlzjrdmyn - qqxkybatri) View more	-	27 May 2009
ARVO2003	Not Applicable	Conjunctivitis, Allergic	14	Epinastine hydrochloride 0.05%	(qaqpsanylb) = No adverse events nor any clinically relevant changes in visual acuity, biomicroscopy, ophthalmoscopy, vital signs, physical examination, or laboratory parameters were observed during the study ccovgjoaqk (rkcisxwbuk )	Positive	01 May 2003