[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of betahistine mesylate tablets (6 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择卫材（中国）药业有限公司为持证商的甲磺酸倍他司汀片（商品名：敏使朗®，规格：6mg）为参比制剂，对兰西哈三联制药有限公司生产，北京哈三联科技有限责任公司提供的受试制剂甲磺酸倍他司汀片（规格：6mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂甲磺酸倍他司汀片和参比制剂甲磺酸倍他司汀片的安全性。

[Translation]

Main purpose of the study: According to the relevant provisions of bioequivalence tests, Betahistine Mesylate Tablets (trade name: Minshilang®, specification: 6mg) of which Eisai (China) Pharmaceutical Co., Ltd. is the licensee was selected as the reference preparation, and the test preparation Betahistine Mesylate Tablets (specification: 6mg) produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. and provided by Beijing Ha Sanlian Technology Co., Ltd. were subjected to human bioequivalence tests for fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose of the study: To observe the safety of oral administration of the test preparation Betahistine Mesylate Tablets and the reference preparation Betahistine Mesylate Tablets in healthy subjects.

Start Date29 Aug 2024

Sponsor / Collaborator

Harbin Medisan Pharmaceutical Co., Ltd.

CTR20241882

/ CompletedNot Applicable

甲磺酸倍他司汀片（6mg）在中国健康志愿者中空腹/餐后状态下的人体生物等效性试验

[Translation] Human bioequivalence study of betahistine mesylate tablets (6 mg) in Chinese healthy volunteers under fasting/fed conditions

主要目的：按有关生物等效性试验的规定，选择卫材（中国）药业有限公司为持证商的甲磺酸倍他司汀片（商品名：敏使朗®，规格：6mg）为参比制剂，对北京紫萌医药科技有限公司提供的受试制剂甲磺酸倍他司汀片（规格：6mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要目的：观察健康志愿受试者口服受试制剂甲磺酸倍他司汀片（规格：6mg）和参比制剂甲磺酸倍他司汀片（商品名：敏使朗®，规格：6mg）的安全性。

[Translation]

Main purpose: According to the relevant provisions of bioequivalence test, Betahistine Mesylate Tablets (trade name: Minshilang®, specification: 6mg) of which Eisai (China) Pharmaceutical Co., Ltd. is the licensee was selected as the reference preparation, and the test preparation Betahistine Mesylate Tablets (specification: 6mg) provided by Beijing Zimeng Pharmaceutical Technology Co., Ltd. was subjected to human bioequivalence test of fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose: To observe the safety of oral administration of the test preparation Betahistine Mesylate Tablets (specification: 6mg) and the reference preparation Betahistine Mesylate Tablets (trade name: Minshilang®, specification: 6mg) by healthy volunteers.

Start Date18 Jun 2024

Sponsor / Collaborator

Beijing Wista Pharma Co., Ltd.

CTR20241929

/ CompletedNot Applicable

甲磺酸倍他司汀片在健康受试者空腹和餐后状态下的随机、开放、单剂量、两制剂、两周期、两序列、交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, crossover bioequivalence study of betahistine mesylate tablets in healthy subjects under fasting and fed conditions

主要目的：比较空腹和餐后单次给药条件下，由浙江仙琚制药股份有限公司生产的甲磺酸倍他司汀片（规格：6mg，受试制剂）与卫材（中国）药业有限公司持证的甲磺酸倍他司汀片（规格：6mg，参比制剂）在健康受试者中吸收程度和速度的差异。次要目的：通过观察健康受试者单次口服受试制剂或参比制剂后的安全性指标，评价甲磺酸倍他司汀片的安全性。

[Translation]

Primary objective: To compare the differences in absorption extent and rate of Betahistine Mesylate Tablets (Specification: 6 mg, test preparation) produced by Zhejiang Xianju Pharmaceutical Co., Ltd. and Betahistine Mesylate Tablets (Specification: 6 mg, reference preparation) certified by Eisai (China) Pharmaceutical Co., Ltd. in healthy subjects under single-dose conditions of fasting and postprandial administration. Secondary objective: To evaluate the safety of Betahistine Mesylate Tablets by observing the safety indicators of healthy subjects after a single oral administration of the test preparation or the reference preparation.

Start Date04 Jun 2024

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Co., Ltd.

100 Clinical Results associated with Betahistine Mesilate

100 Translational Medicine associated with Betahistine Mesilate

100 Patents (Medical) associated with Betahistine Mesilate

176

Literatures (Medical) associated with Betahistine Mesilate

01 Dec 2024·Sleep Medicine

Signal detection of drugs associated with obstructive and central sleep apnoea

Article

Author: Joyeux-Faure, M ; Khouri, C. ; Joyeux-Faure, M. ; Pepin, J L ; Revol, B ; Hlavaty, A ; Pepin, J.L. ; Khouri, C ; Cracowski, J L ; Hlavaty, A. ; Borel, J C ; Jambon-Barbara, C ; Jambon-Barbara, C. ; Borel, J.C. ; Revol, B. ; Cracowski, J.L.

We aim to discover new safety signals of drug-induced sleep apnoea (SA), a global health problem affecting approximately 1 billion people worldwide. We first conducted a series of sequence symmetry analyses (SSA) in a cohort composed from all patients who received a first SA diagnosis or treatment between 2006 and 2018 in the Echantillon Généraliste des Bénéficaires (EGB), a random sample of the French healthcare database. We used two primary outcomes to estimate the sequence ratio (SR) for all drug classes available in France: a sensitive one (diagnosis or treatment of SA) and a specific one (Positive Airway Pressure (PAP) therapy). We then performed disproportionality analyses using the "Bayesian neural network method" on all cases of sleep apnoea (MedDRA high level term) reported up to November 2023 in the World Health Organisation (WHO) pharmacovigilance database. Among the 728,167 individuals, 46,193 had an incident diagnosis or treatment for SA and 17,080 had started an incident treatment by PAP therapy. Fifty-eight drug classes had a significant SR, with 7 considered highly plausible: opium alkaloids and derivatives, benzodiazepine derivatives, other centrally acting agents, other anxiolytics, carbamic acid esters, quinine and derivatives and antivertigo preparations; with consistent signals found for the first 3 drug classes in the disproportionality analysis. In this signal detection study, we found that opioids, benzodiazepines (but not Z-drugs) and myorelaxing agents are associated with the onset or aggravation of SA. Moreover, a new safety signal for antivertigo preparations such as betahistine emerged and needs to be further explored.

01 Nov 2024·Ear, Nose & Throat Journal

Which Canal BPPV Should be Checked for Residual Disease after 1 Week?

Article

Author: Öner, Fatih

Objectives: The study aimed to determine the residual disease rate due to the affected canal in patients diagnosed with benign paroxysmal positional vertigo (BPPV) and reveal the factors affecting the residual disease. Materials and Methods: A comprehensive investigation was conducted to determine the effect of the affected canal, sociodemographic data, body mass index, hospital admission time, systemic disease history, betahistine use, and previous otologic vertigo history on the residual BPPV rate. This investigation was carried out on 201 patients who underwent repositioning maneuvers with BPPV diagnosis and came for a follow-up 1 week later, ensuring a robust and reliable dataset. Results: Two hundred one patients were included in the study: 91 (45.3%) male and 110 (54.7%) female. The mean age of the patients was 60.44 + 13.83 (min = 23-max = 90) years. Residual disease was significantly higher in bilateral canal involvement ( P = .001), anterior canal involvement, and those presenting 72 hours after the onset of the vertigo attack ( P = .001). There was no significant difference between residual disease and those with successful initial maneuver results regarding age, gender, obesity, canalolithiasis, or cupulolithiasis. Conclusion: The most effective treatment for BPPV is canalith reposition maneuvers. We recommend that patients be called for follow-up after 1 week, especially in cases of anterior canal involvement and bilateral involvement. These findings provide valuable insights for the management of BPPV.

01 Oct 2024·Current Opinion in Otolaryngology & Head & Neck Surgery

Update on the pathophysiology, diagnosis and management of Ménière's disease

Review

Author: Perez-Carpena, Patricia ; Lopez-Escamez, Jose A.

Purpose of reviewThe aim of this work is to summarize the main advances on the pathophysiology, diagnosis, and treatment of Meniere's disease (MD).Recent findingsDifferent immune responses to biotic stimuli may trigger MD, with subgroups identified based on cytokine and genetic profile, suggesting potential benefits from immune therapy, including antiallergic medication. Genetic and epigenetic research, along with imaging studies, reveal the complexity of MD, involving inflammation, immunity, and metabolic processes. Advanced imaging techniques define specific temporal bone features and endolymphatic hydrops, while machine learning models enhance diagnostic accuracy through clinical and laboratory data analysis. Differentiating MD from vestibular migraine remains challenging due to overlapping symptoms, but combining vestibular tests, audiological assessments, and biomarkers like cytokines and chemokines shows promise. Pharmacological treatments such as betahistine or corticosteroids show varying effectiveness and require further research according to immune subgroups. Surgical options like endolymphatic sac decompression, semicircular canal occlusion and labyrinthectomy are restricted to intractable cases.SummaryResearch into MD aims to improve diagnosis and treatment through genetic, immunological, and advanced imaging studies. Current treatments include pharmacological, intratympanic, and surgical interventions, but current research supports a personalized approach based on clinical and molecular re-definition of patient subgroups.

News (Medical) associated with Betahistine Mesilate

02 Apr 2024

·www.pharmaceutical-technology.com

Eisai to divest rights for two therapies to Kaken

Eisai will continue to focus on creating and delivering products to target disease. Credit: mkfilm/Shutterstock.com. Eisai has signed an agreement for the divestiture of rights for Merislon and Myonal, two of its long-standing products in Japan, to Kaken Pharmaceutical . The transaction is valued at Y3.8bn ($25.10m). Merislon treats vertigo and equilibrium disturbances and Myonal is a muscle relaxant, which patients have used since their respective launches in 1969 and 1983. The agreement stipulates that Eisai will complete the transfer of marketing capabilities by March 2025, followed by manufacturing and marketing approval transfer. The deal will not impact Eisai’s consolidated financial forecast for 31 March 2024. See Also: China accepts Innovent-HUTCHMED’s endometrial cancer therapy NDA Magazine: What’s next for AAV gene therapies in 2024? The company stated: “Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products’ disease areas, is the optimal choice to ensure they continue contributing to a greater number of patients.” Eisai will continue to focus on creating and delivering products to target diseases with higher unmet medical needs such as neurology, oncology and global health. Kaken is a research and development-driven pharmaceutical company that focuses on orthopaedics and dermatology. Earlier this month, Eisai received approval for the amyloid beta-directed antibody Leqembi (lecanemab-irmb) in China to treat mild cognitive impairment associated with Alzheimer’s disease (AD) and mild AD dementia. Leqembi, developed in partnership with BioArctic, will be available in the region in the third quarter of 2024. The approval in China is based on the international Phase III Clarity AD study. Eisai will be responsible for distribution and information provision through expert medical representatives.

Drug ApprovalPhase 3AcquisitionLicense out/inBiosimilar

29 Mar 2024

·firstwordpharma.com

Eisai to transfer rights for vertigo, muscle spasm drugs in Japan

Eisai said Friday that it agreed to sell Japanese rights for the vertigo treatment Merislon (betahistine mesilate) and the antispasmodic drug Myonal (eperisone hydrochloride) to Kaken Pharmaceutical.The drugs have long been used by patients in Japan since their respective launches there decades ago, according to the Eisai. "Divesting rights for these products to Kaken, which has strengths in the products' disease areas, is the most optimal choice to ensure them to continue contributing to a greater number of patients," it added.Eisai will receive JPY 3.8 billion ($25 million) under the deal, and will proceed with the transfer of marketing capabilities by March 2025, followed by the transfer of manufacturing and marketing approval.Towards the end of 2022, the drugmaker agreed to offload US rights to its epilepsy drug Fycompa (perampanel) to Catalyst Pharmaceuticals for an upfront payment of $160 million.The company said it doesn't anticipate any changes to its consolidated financial forecast for the period ending March 31, 2024, as a result of the latest deal.

License out/inAcquisition

29 Mar 2024

·www.eisai.com

EISAI TO DIVEST RIGHTS FOR MERISLON® AND MYONAL® IN JAPAN TO KAKEN PHARMACEUTICAL

For Print（143KB） March 29, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into an agreement to divest its rights for vertigo and equilibrium disturbance treatment Merislon® (generic name: betahistine mesilate) and muscle relaxant Myonal® (generic name: eperisone hydrochloride) in Japan to Kaken Pharmaceutical Co., Ltd. (Headquarters: Tokyo, “Kaken”). Merislon and Myonal have been widely used by patients in Japan for a long time since their launch in 1969 and 1983, respectively. Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products’ disease areas, is the most optimal choice to ensure them to continue contributing to a greater number of patients. Under the terms of the agreement, Eisai will receive 3.8 billion yen for the transfer, and proceed with transfer of the marketing capability by March 2025, followed by the transfer of the manufacturing and marketing approval. Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2024. Driven by our hhc concept, Eisai strives to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas: Neurology, Oncology and Global Health. As an hhceco company, Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities by creating solutions through building an ecosystem in collaboration with other industries. Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 [Notes to editors] Kaken Pharmaceutical Co., Ltd. (“Kaken”) is a pharmaceutical company, established in 1948, and its corporate philosophy is to help improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals. Kaken is an R&D-driven pharmaceutical company focusing on dermatology and orthopedics, and are committed to creating and providing innovative medicines to bring smiles to the faces of patients, their families, and the medical professionals involved in their treatment. For more information, please visit https://www.kaken.co.jp/english/ Full text（143KB）

License out/inDrug ApprovalAcquisition

100 Deals associated with Betahistine Mesilate

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R&D Status

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Indication	Country/Location	Organization	Date
Vertigo	Japan	Eisai Co., Ltd.	01 Jan 1969
Meniere Disease	China	-	-

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