[Translation] Single-centre, randomized, open-label, two-period, two-sequence, crossover, single-dose design in healthy adult subjects to evaluate bioequivalence studies in the fasted/fed state.

主要目的：本研究以厦门恩成制药有限公司研发的甲磺酸倍他司汀片（规格：6 mg）为受试制剂，按生物等效性研究的有关规定，以原研地产化药品厂家卫材（中国）药业有限公司生产的甲磺酸倍他司汀片（商品名：敏使朗®，规格：6 mg）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察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（商品名：敏使朗®）在健康受试者中的安全性。

[Translation]

Main purpose: In this study, betahistine mesylate tablets (specification: 6 mg) developed by Xiamen Encheng Pharmaceutical Co., Ltd. Betahistine mesylate tablets (trade name: Minshilang®, specification: 6 mg) produced by China Material (China) Pharmaceutical Co., Ltd. was used as the reference preparation, and the test preparation and the reference preparation were evaluated on an empty stomach/after meal. Bioequivalence after administration under conditions. Secondary purpose: To observe the safety of the test preparation Betahistine Mesylate Tablets and the reference preparation Betahistine Mesylate Tablets (trade name: Minshilang®) in healthy subjects.

Start Date11 Apr 2023

Sponsor / Collaborator

Xiamen Encheng Pharmaceutical Co Ltd

NCT05604937 / RecruitingNot Applicable

Safety and Efficacy of Shi's Traumatology Osteopathic Manipulation for Cervicogenic Dizziness: A Randomized, Controlled, Multicenter Trial

This is a randomized, controlled, multi-center clinical trail to objectively evaluate safety and efficacy of shi's traumatology Osteopathic manipulative treatment for cervicogenic dizziness. Multi-center study is planned to be carried out in 4 medical institutions in Shanghai, including Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Yueyang traditional chinese and western medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Baoshan traditional chinese and western medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, and Shanghai General Hospital. Randomly Assigned 106 patients (18 < ages <65 ) who meet the diagnostic criteria of cervicogenic dizziness to the treatment group and the control group by a ratio of 1:1, using betahistine mesylate tablets as positive control. Observe and compare the variations of Dizziness Handicap Inventory (DHI) from baseline in two groups after 2 weeks treatment, using Dizziness Handicap Inventory (DHI) as the main efficacy index. After the end of treatment, performing 4weeks follow-up, focus to compare the recurrence rate of vertigo symptoms in the period of 4weeks follow-up after 2 weeks treatment. The safety indexes will be observed and compared, including vital sign, physical examination and adverse event, in the trail.
The electronic case Report Form (eCRF) will be used to collect and manage the study data.
The data of the primary efficacy index, DHI, patient's vertigo condition report, both use electronic patient-reported outcome (e-PRO) to collect. To ensure quality of study, this trail intends to set safeguard measures for clinical trail including setting Clinical Research Associate (CRA) to monitor study quality, evaluating efficacy by the third person, training manual therapy physicians, make access and regular and irregular assessment consistent.

Start Date02 Feb 2023

Sponsor / Collaborator

Shuguang Hospital

CTR20221569 / CompletedNot Applicable

甲磺酸倍他司汀片（6mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of betahistine mesylate tablets (6 mg) under fasting and postprandial dosing conditions in healthy Chinese subjects

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/片）为参比制剂，对石家庄四药有限公司生产的受试制剂甲磺酸倍他司汀片（规格：6mg/片）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。次要研究目的：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/片）和参比制剂甲磺酸倍他司汀片（商品名：敏使朗，规格：6mg/片）的安全性。

[Translation]

Main research purpose: According to the relevant bioequivalence test regulations, Eisai (China) Pharmaceutical Co., Ltd. was selected as the licensee for betahistine mesylate tablets (trade name: Minshilang, specification: 6 mg/tablet) ) as the reference preparation, the test preparation Betahistine Mesylate Tablets (specification: 6 mg/tablet) produced by Shijiazhuang No. Whether the difference between the absorption rate and degree of absorption of the Chinese medicine and the reference preparation is within an acceptable range, and evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe healthy volunteers taking the test preparation betahistine mesylate tablets (specification: 6mg/tablet) and the reference preparation betahistine mesylate tablets (trade name: Minshilang, Specifications: 6mg/tablet) safety.

Start Date21 Jul 2022

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

100 Clinical Results associated with Betahistine Mesilate

100 Translational Medicine associated with Betahistine Mesilate

100 Patents (Medical) associated with Betahistine Mesilate

Literatures (Medical) associated with Betahistine Mesilate

12 Oct 2023·Brain stimulation

Meniere Disease treated with transcutaneous auricular vagus nerve stimulation combined with betahistine Mesylate: A randomized controlled trial.

Article

Author: Dong Wu ; Bo Liu ; Yunqing Wu ; Yu Wang ; Jingyi Sun ; Jun Yang ; Jinping Duan ; Gang Liu ; Kai Cao ; Yi Zhang ; Peijing Rong

BACKGROUND:

Meniere Disease is a clinical condition defined by hearing loss, tinnitus, and aural fullness symptoms, there are currently no any medications approved for its treatment.

OBJECTIVE:

To determine whether taVNS as an adjunctive therapy could relieve symptoms and improve the quality of life in patients with Meniere disease.

METHODS:

In this Single-center, single blind, randomized trial, participants were assigned to transcutaneous auricular vagus nerve stimulation (taVNS) group and sham taVNS group. The primary outcome measures comprised Tinnitus Handicap Inventory, Dizziness Handicap Inventory, Pure Tone Auditory, Visual analogue scale of aural fullness. Secondary outcome measures comprised the 36-Item Short Form Health Survey, video head impulse test, and the caloric test.

RESULTS:

After 12 weeks, the THI (-11.00, 95%CI, -14.87 to -7.13; P < 0.001), DHI (-47.26, 95%CI, -50.23 to -44.29; P < 0.001), VAS of aural fullness (-2.22, 95%CI, -2.95 to -1.49; P<0.01), and Pure Tone Thresholds (-7.07, 95%CI, -9.07 to -5.06; P<0.001) were significantly differed between the two groups. In addition, SF36(14.72, 95%CI, 11.06 to 18.39; P < 0.001), vHIT (RD, 0.26, 95 % CI, -0.44 to -0.08, RR, 0.43, 95 % CI, 0.22 to 0.83, P < 0.01), and the caloric test (RD, -0.24, 95 % CI, -0.43 to -0.04, RR, 0.66, 95 % CI, 0.44 to 0.95, P = 0.02) have significant difference between two group, respectively.

CONCLUSIONS:

These findings suggest that taVNS combined with Betahistine Mesylate relieve symptoms and improve the quality of life for patients with Meniere Disease. taVNS can be considered an adjunctive therapy in treatment of Meniere Disease.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT05328895.

12 Aug 2022·Zhongguo zhen jiu = Chinese acupuncture & moxibustion

[Micro-needle knife in treatment of cervical vertigo and its effect on vertebral artery hemodynamics].

Article

Author: Jian-Chang Luo ; Luo-Dan Wang ; Wen-Bin Xu ; Bo-Xu Lang

OBJECTIVE:

To compare the effect of micro-needle knife therapy and betahistine mesilate tablets in the treatment of cervical vertigo (CV) and the influence on the mean blood flow velocity (Vm) of vertebral artery.

METHODS:

A total of 200 patients with CV were randomly divided into a micro-needle knife group (100 cases, 5 cases dropped off) and a medication group (100 cases, 3 cases dropped off). In the micro-needle knife group, micro-needle knife was performed on the suboccipital triangle of the atlantoaxial segment of the posterior neck, once every other day, for a total of 7-time treatment. The medication group received oral betahistine mesilate tablets, 6 mg each time, three times a day, for 14 consecutive days. The dizziness handicap inventory (DHI) scores of the two groups were observed before treatment, after treatment and during follow-up 3 months after treatment; the Vm of vertebral artery was compared between the two groups before and after treatment, and the clinical effect was evaluated during follow-up.

RESULTS:

After treatment and during follow-up, the DHI scores of the two groups were lower than those before treatment (P<0.001), and those in the micro-needle knife group were lower than the medication group (P<0.001). After treatment, the Vm of bilateral vertebral arteries in both groups was higher than that before treatment (P<0.05), and that in the micro-needle knife group was higher than the medication group (P<0.05). The total effective rate of the micro-needle knife group was 96.8% (92/95), which was higher than 67.0% (65/97) of the medication group (P<0.001).

CONCLUSION:

Micro-needle knife therapy can improve vertigo symptoms and balance dysfunction, increase the mean blood flow velocity of vertebral artery in CV patients, and its clinical efficacy is better than oral betahistine mesilate tablets.

25 Feb 2022·Zhongguo gu shang = China journal of orthopaedics and traumatology

[A case control study:the treatment of cervical vertigo with micro needle knife].

Article

Author: Bo-Xu Lang ; Jian-Chang Luo ; Jia-Wang Lang ; Luo-Dan Wang ; Wen-Bin Xu

OBJECTIVE:

To observe the clinical efficacy of micro needle knife therapy on cervical vertigo.

METHODS:

A total of 300 patients with cervical vertigo treated from January 1, 2017 to December 31, 2019 were randomly divided into micro needle knife group (96 cases, 4 cases falling off), traditional acupuncture group (96 cases, 4 cases falling off) and oral drug group(95 cases, 5 cases falling off). The micro needle knife group was treated with micro needle knife in the local upper cervical segment once every other day for 7 times; the traditional acupuncture group was treated with traditional acupuncture once a day for 2 weeks;the oral drug group was given Merislon (betahistine mesilate tablets) orally, 6 mg each time, 3 times a day for 2 weeks. The patients were followed up before treatment, at the end of treatment and 3 months after treatment. The dizziness handicap inventory(DHI) was observed and the curative effect was evaluated according to the DHI score.

RESULTS:

At the end of the course of treatment and 3 months after the treatment, DHI scores of the three groups were significantly lower than those before treatment(P<0.01), and the DHI scores of micro needle knife group were lower than those of traditional acupuncture group and oral drug group at the same time point after treatment (P<0.01). There was no statistically significant difference in DHI scores between traditional acupuncture group and oral drug group at the same time after treatment(P< 0.05). The curative effect was evaluated according to DHI score:in micro needle knife group, 50 cases were cured, 28 cases were markedly effective, 14 cases were improved, the total effective rate was 95.83%; in traditional acupuncture group, 28 cases were cured, 26 cases were markedly effective, and 24 cases were improved, with the total effective rate of 81.25%;in oral drug group, 18 cases were cured, 20 cases were markedly effective, and 28 cases were improved, with the total effective rate of 69.47%. The total effective rate of micro needle knife group was significantly higher than that of other two groups (χ²=45.956, P=0.000). Among the cured patients in the three groups, the time required in the micro needle knife group was significantly less than that in the traditional acupuncture group and oral drug group(F=18.796, P=0.000).

CONCLUSION:

Micro needle knife loosening atlantoaxial soft tissue has obvious curative effect on cervical vertigo which clinical cure rate, effective rate and treatment time required for cured patients are better than traditional acupuncture and oral drug.

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

10 Apr 2023

·www.biospace.com

Altamira Therapeutics Reports Positive Conclusions from Independent Meta-Analysis of Clinical Studies with Betahistine in Treatment of Most Common Cause of Vertigo

Published meta-analysis shows statistically significant improvement in dizziness handicap for betahistine treatment over standard of care procedure alone in patients suffering from BPPV Altamira to application for intranasal betahistine (AM-125) with FDA in May 2023, including protocol for Phase 2 clinical trial in BPPV Altamira intends to partner or divest AM-125 as part of its legacy assets in a strategic pivot to its RNA delivery technology platforms HAMILTON, BERMUDA / ACCESSWIRE / April 10, 2023 / Altamira Therapeutics ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today reported highlights from a peer reviewed article showing efficacy of oral betahistine in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV) when administered along with a canal repositioning procedure, the Epley maneuver. The article was published in the journal Medicine[1] and describes the results from a meta-analysis of nine randomized controlled trials with 860 posterior canal BPPV patients, of which 432 were treated with Epley's maneuver plus betahistine, and 428 solely underwent Epley's maneuver. The meta-analysis concluded that Epley's maneuver plus betahistine resulted in a significantly greater reduction in dizziness handicap as measured by the Dizziness Handicap Inventory (DHI) compared to Epley's maneuver alone (p = 0.001). BPPV is characterized by repeated episodes of vertigo (dizziness) produced by changes in the head position relative to gravity, e.g. when tipping the head backward. It is typically caused by dislodged inner ear particles (otoconia) in one of the semicircular canals, most often the posterior canal. The debris elicits unwanted vestibular stimulation and is often cleared through physical repositioning procedures such as the Epley maneuver, which is strongly recommended by the Clinical Practice Guideline of the American Academy of Otolaryngology - Head and Neck Surgery. Since a patient may experience dizziness and instability for some time even after a successful maneuver, betahistine as an antivertigo drug is frequently administered to help accelerate their resolution. BPPV is the most common type of vertigo, which accounts for 17 to 42% of all diagnosed cases. A primary complaint of dizziness accounts for 5.6 million clinic visits in the United States per year.[2] Patients, suffering from BPPV, experience significant inconveniences and disabilities during symptomatic episodes, as they interfere with day-to-day activities such as driving a car or climbing stairs. BPPV generally emerges in the elderly with a peak onset in the fifth and sixth decades. Altamira has been developing AM-125, a patented formulation of betahistine for intranasal administration, for the treatment of acute vestibular syndrome (AVS), which may be triggered by a variety of causes including trauma, infection or inner ear fluid disturbances such as in BPPV. By avoiding the fast metabolism after oral intake, intranasal delivery of AM-125 achieves higher bioavailability of betahistine (5-to-29 times higher). AM-125 has been successfully tested in a Phase 2 clinical trial ("TRAVERS") with patients suffering from AVS following vestibular surgery. Compared to placebo, AM-125 treatment helped accelerate vestibular compensation and alleviate signs and symptoms of vestibular dysfunction. The Company expects to IND application for intranasal betahistine (AM-125) with the FDA in May 2023, including the protocol for its Phase 2 clinical trial in BPPV. "We are pleased to see betahistine's clinical utility further confirmed in this meta-analysis of several studies in BPPV patients," commented Thomas Meyer, Ph.D., Altamira's founder, chairman and CEO. "Following the positive outcomes in surgery-induced AVS in the TRAVERS trial, we feel vindicated in our choice of BPPV to advance the clinical development program for AM-125. Where marketed, BPPV has traditionally been one of the most frequent indications for oral betahistine. We look forward to submitting the IND application shortly which will be an important milestone on our way to transfer the innovative AM-125 program to one or several partners as we are repositioning the Company around our RNA delivery technology." About Betahistine Globally, there has been a dearth of innovation for treating vertigo for decades. Betahistine, a small molecule structural analog of histamine, acts as an agonist at the H1 histamine receptor and as an antagonist at the H3 histamine receptor. Unlike histamine, it crosses the blood-brain-barrier. Betahistine is known to increase the release of histamine, acetylcholine, dopamine and norepinephrine in the brain. It increases cochlear, vestibular and cerebral blood flow and facilitates vestibular compensation and inhibits neuronal firing in the vestibular nuclei. Betahistine for oral administration is approved in about 115 countries (with the U.S. being a notable exception) for the treatment of vertigo and Meniere's disease. Despite its good safety profile, the clinical utility of orally administered Betahistine is limited due to poor bioavailability. About AM-125 AM-125 is an intranasal formulation of betahistine. Because of its ability to circumvent first-pass-metabolism, AM-125 has been shown to have 5-to-29 times higher bioavailability than orally administered betahistine. Altamira Therapeutics is developing AM-125 for the treatment of acute vestibular syndrome. With its incidence and prevalence increasing with age, vestibular dysfunction affects more than one third of the U.S. population 40 years of age and older. About Altamira Therapeutics Altamira Therapeutics (Nasdaq:CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic targets (OligoPhore™ / SemaPhore™ delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and shall be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or licensing-out its legacy assets in allergology and viral infection (Bentrio® OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: . Forward-Looking Statements This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the success of the continued commercialization of Bentrio and success of strategic transactions, including licensing or partnering, with respect to Bentrio or any other legacy assets, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2021, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira Therapeutics does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. Contact: Hear@altamiratherapeutics.com 800-460-0183 SOURCE: Altamira Therapeutics Ltd. View source version on accesswire.com:

Phase 2Drug ApprovalClinical ResultINDsiRNA

100 Deals associated with Betahistine Mesilate

External Link

KEGG	Wiki	ATC	Drug Bank
D01592	-	N07CA01	-

R&D Status

Indication	Highest Phase	Country/Location	Organization
Meniere Disease	Approved	JP More	Eisai Co., Ltd. More
Vertigo	Approved	JP More	Eisai Co., Ltd. More

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