A Phase III, Randomized, Double Blind, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Dextromethorphan Hydrobromide plus Bupropion Hydrochloride Extended Release Tablets versus Bupropion Hydrochloride Sustained Release Tablets in Adult Patients with Major Depressive Disorder (MDD). ?

Start Date16 Jun 2023

Sponsor / Collaborator

Exemed Pharmaceuticals

CTRI/2022/11/047227 / RecruitingPhase 4

A Multicentric, Phase IV Clinical Trial to Evaluate Safety and Efficacy Of Fixed Dose Combination Of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Sustained Release Suspension in Patients Suffering from Dry Cough Associated with Sneezing and/ or Running Nose and/ or Throat Irritation

Start Date21 Nov 2022

Sponsor / Collaborator-

CTR20212976 / CompletedNot Applicable

氢溴酸右美沙芬硫酸奎尼丁胶囊 20mg/10mg 随机、开放、单剂量、两制剂、双交叉空腹及餐后状态下人体生物等效性试验

[Translation] Dextromethorphan hydrobromide quinidine sulfate capsules 20mg/10mg randomized, open-label, single-dose, two-dose, double-crossover fasting and postprandial human bioequivalence study

主要目的：研究健康受试者在空腹及餐后状态下，单次分别口服受试制剂氢溴酸右美沙芬硫酸奎尼丁胶囊（规格：20mg/10mg）与参比制剂氢溴酸右美沙芬硫酸奎尼丁胶囊（商品名：Nuedxta®，规格：20mg/10mg），考察两制剂在健康人体内的生物等效性，为正式试验的样本量计算提供依据。次要目的：观察受试制剂氢溴酸右美沙芬硫酸奎尼丁胶囊和参比制剂Nuedxta®在健康受试者中的安全性。

[Translation]

Main purpose: To study healthy subjects taking the test preparation dextromethorphan hydrobromide quinidine sulfate capsules (specification: 20mg/10mg) and the reference preparation dextromethorphan hydrobromide orally in a single dose respectively under fasting and postprandial states. Quinidine Sulfate Capsules (trade name: Nuedxta®, specification: 20mg/10mg), to investigate the bioequivalence of the two preparations in healthy humans, to provide a basis for the calculation of the sample size of the formal test. Secondary objective: To observe the safety of test preparation dextromethorphan hydrobromide quinidine sulfate capsules and reference preparation Nuedxta® in healthy subjects.

Start Date19 Dec 2021

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

100 Translational Medicine associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

100 Patents (Medical) associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

Literatures (Medical) associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

01 Dec 2024·Current Drug Delivery

Supersaturation Behavior: Investigation of Polymers Impact on Nucleation Kinetic Profile for Rationalizing the Polymeric Precipitation Inhibitors

Article

Author: Rani, Nidhi ; Sharma, Prerna ; Guarve, Kumar ; Malik, Anuj ; Handa, Uditi

Background:Although nucleation kinetic data is quite important for the concept of supersaturation behavior, its part in rationalizing the crystallization inhibitor has not been well understood.Objective:This study aimed to investigate the nucleation kinetic profile of Dextromethorphan HBr (as an ideal drug, BCS-II) by measuring liquid-liquid phase segregation, nucleation induction time, and Metastable Zone width.Methods:Surfeit action was examined by a superfluity assay of the drug. The concentration was scrutinized by light scattering techniques (UV spectrum (novel method) and Fluorometer (CL 53)).Results:The drug induction time was 20 min without polymer and 90 and 110 min with polymers, such as HPMC K15M and Xanthan Gum, respectively. Therefore, the order of the polymer's ability to inhibit nucleation was Xanthan Gum > HPMC K15M in the medium (7.4 pH). Similarly, the drug induction time was 30 min without polymer and 20, 110, and 90 min with polymers, such as Sodium CMC, HPMC K15M, and Xanthan Gum, respectively. Therefore, the order of the polymer's ability to inhibit nucleation was HPMC K15M > Xanthan Gum > Sodium CMC in SIFsp (6.8 pH), which synchronizes the polymer’s potentiality to interdict the drug precipitation.Conclusion:The HPMC K15M and xanthan Gum showed the best crystallization inhibitor effect for the maintenance of superfluity conditions till the drug absorption time. The xanthan gum is based on the “glider” concept, and this shows the novelty of this preliminary research. The screening methodology used for rationalizing the best polymers used in the superfluity formulations development successfully.

02 Jan 2024·Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

ALSUntangled #71: Nuedexta

Review

Author: Brown, Andrew ; Li, Xiaoyan ; Bromberg, Mark ; Beauchamp, Morgan ; Staats, Kim ; Sun, Yuyao ; Carter, Greg ; Barkhaus, Paul ; Benatar, Michael ; Mascías Cadavid, Javier ; Jhooty, Sartaj ; Ennist, Dave ; Wicks, Paul ; Bedlack, Richard ; Bertorini, Tulio ; Pattee, Gary

Nuedexta is a combination of dextromethorphan hydrobromide and quinidine sulfate and was approved by the Food and Drug Administration (FDA) in 2010 to treat pseudobulbar affect (PBA). There have since been anecdotal case reports of bulbar function improvements after Nuedexta treatment. Here, we review the off-label use of Nuedexta for improving bulbar function in people with ALS. Nuedexta has plausible mechanisms for protecting brain stem motor neurons via its effects on S1R and glutamate excitotoxicity. Recent clinical trials support that Nuedexta can improve bulbar function in PALS, with or without PBA. Nuedexta causes mild to moderate side effects. Based on this information, we support considering Nuedexta treatment for bulbar dysfunction in ALS patients with or without PBA.

01 Jan 2024·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Rapid screening and multicomponent quantifications of active components of oral syrup over-the-counter medications by Raman and UV–visible spectroscopy and multivariate regression analysis

Article

Author: Fakayode, Sayo O ; Chohan, Harmeet ; Dassow, Bailey ; Bolton, Brinkley ; Galvez, Kairy

Over-the-counter medications (OTCMs) are frequently recommended as a first-line treatment for common ailments, diseases, and illnesses. Oral liquid dosage forms are advantageous for rapid absorption with no dissolution time and are easier for pediatric and geriatric consumers to swallow. The production of these medicines by pharmaceutical industry makes them readily available to the public. Although the US Food and Drug Administration (FDA) provides strict guidelines to drug manufacturers of these products; the risk of counterfeiting is a global issue. This can lead to several adverse effects and health issues. Here, we report a fast screening and quality assurance method using Raman and UV-visible spectroscopy combined with Principal Component Analysis (PCA) and Partial-Least-Square (PLS) regression of commonly used OTCM oral syrups. PLS regressions of UV-visible absorption spectra were used for multicomponent quantifications of the active component (acetaminophen, guaifenesin, dextromethorphan HBr, and phenylephrine HCl) concentrations of OTMCs in flavored (sugar or sugar-free) oral syrups. Raman and UV-visible spectral responses varied based on the type and concentration of the active component analyzed. PCA of the spectral data provided pattern recognition of the oral syrup OTCM. The developed PLS method demonstrated good linearity with an R² > 0.9784 and high sensitivity with a low detection limit of 0.02 mg/mL for acetaminophen and guaifenesin. Moreover, the simultaneous quantification of concentrations of all active components by the described method yielded good accuracies ranging from 88 to 94%. This study provides an example of the benefits of the combined use of Raman and UV-vis spectral profiling, PCA, and PLS regression for the quality analysis of oral syrups OTCM providing multicomponent quantification of active components with no need for sample extraction. The reported method can be easily adapted and scaled for online detection analysis used in the drug manufacturing industry, both in-situ and field analysis, and for the quality control of syrups OTCM by regulatory agencies and quality control officers.

News (Medical) associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

23 May 2023

·www.prnewswire.com

ZENVIA RECEIVES NASDAQ NOTIFICATION REGARDING MINIMUM BID PRICE DEFICIENCY

SÃO PAULO, May 23, 2023 /PRNewswire/ -- On May 16, 2023, Zenvia Inc. (the "Company") received a written notice (the "Notice") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon the closing bid price of the Company's Class A common shares (the "Securities") for the 30 previous consecutive business days, it no longer met Nasdaq's minimum bid price requirement of US$1 per share (the "Minimum Bid Price Requirement"), as set forth by Nasdaq Listing Rules 5550(a)(2) and 5810(c)(3)(A). The Notice has no immediate effect on the listing of the Securities, which continue to trade uninterrupted on The Nasdaq Capital Market under the symbol "ZENV" and the Company's business operations are not affected by the receipt of the Notice. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided with an initial 180-calendar day period, ending on November 13, 2023, (the "Initial Compliance Period") to regain compliance with the Minimum Bid Price Requirement. If at any time during the Initial Compliance Period, the closing bid price per share of the Securities is of at least U$$1.00 for a minimum of 10 consecutive business days, it is expected that Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed. If the Company does not regain compliance within the Initial Compliance Period, it may be eligible for an additional 180- calendar day compliance period, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(ii), provided that it meets the applicable market value of publicly held shares requirement for continued listing and all applicable standards for initial listing on the Nasdaq Capital Market (except the Minimum Bid Price Requirement) and notifies Nasdaq of its intent to cure this deficiency during this second compliance period. If the Company has not regained compliance within the period(s) granted by Nasdaq, including any extensions, the Securities will be subject to delisting, pending an appeal to the Nasdaq Hearing Panel. The Company intends to monitor the closing bid price of the Securities and will, if appropriate, consider implementing available options to resolve the noncompliance with the Minimum Bid Price Requirement, including, but not limited to implement a reverse stock split of the Securities. There can be no assurance that the Company will be able to regain compliance with Minimum Bid Price Requirement or that, if needed, Nasdaq will grant the Company an additional compliance period. Contacts About ZENVIA With operations throughout Latin America and nearly 14,000 clients, ZENVIA is driven by the purpose of empowering companies to create unique experiences for end-consumers through its unified CX SaaS end-to-end platform. ZENVIA empowers companies to transform their existing customer experience from non-scalable, physical and impersonal interactions into highly scalable, digital-first and hyper-contextualized experiences across the customer journey. ZENVIA's platform provides a combination of (i) SaaS focused on campaigns, sales teams, customer service and engagement, (ii) tools, such as software application programming interfaces, or APIs, chatbots, single customer views, journey designers, documents composer and authentication, and (iii) channels, such as SMS, Voice, WhatsApp, Instagram and Webchat. Its comprehensive platform assists customers across multiple use cases, including marketing campaigns, customer acquisition, customer onboarding, warnings, customer services, fraud control, cross-selling and customer retention, among others. ZENVIA's shares are traded on Nasdaq, under the ticker ZENV. Forward Looking Statements This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "aim," "anticipate," "believe," "can," "continue," "estimate," "expect," "intend," "likely," "may," "might," "plan," "potential," "probable," "project," "seek," "should," "target," "would," or the opposite of these terms or other similar expressions. Actual results may differ materially from the results anticipated by the Company's forward-looking statements due to certain risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future. SOURCE Zenvia

04 Nov 2022

·endpts.com

Avanir files WARN notice for 100+ layoffs from California as merger with parent Otsuka looms

Another biotech is axing part of its workforce, joining dozens more over the last year. California-based Avanir Pharmaceuticals filed a WARN notice in late October detailing 109 layoffs in California at its headquarters in Aliso Viejo, on the south side of Los Angeles. Avanir did not respond to multiple queries from Endpoints News . The biotech issued another WARN notice earlier this year, when it outlined 16 layoffs back in August that would become effective October 14. The biotech did not immediately respond to a query from Endpoints at the time. This comes after Otsuka subsidiary Otsuka America Pharmaceutical announced on October 21 that it would be integrating Avanir into its business, effective January 1, 2023. Otsuka acquired Avanir back in 2015 for $3.5 billion. Avanir, founded as Lidak Pharmaceuticals back in 1988, is a CNS biotech and the maker of Nuedexta, a drug FDA-approved for pseudobulbar affect, a disease characterized by uncontrollable crying or laughing. Nuedexta is at the center of a $116 million settlement in civil and criminal penalties that Avanir agreed to pay in 2019. That settlement revolved around claims from whistleblowers that Avanir reps had paid doctors to prescribe the drug in nursing homes as a way to control dementia patients, an unapproved indication for the drug. On top of that, the DOJ said at the time that Avanir violated anti-kickback law by paying a doctor to prescribe Nuedextra to beneficiaries of federal healthcare programs, among other examples. Avanir did not admit wrongdoing as part of the settlement. Reeling from a hefty civil and criminal settlement, Avanir stumbles into PhIII Alzheimer's failure Aside from Nuedexta, Avanir has been focusing on a candidate for agitation in patients with Alzheimer’s Dementia (currently in Phase III trials). Other drugs being investigated include drugs for negative symptoms of schizophrenia, intermittent explosive disorder and negative behaviors linked to traumatic brain injuries. Avanir joins a host of companies — both big and small — in trimming companies and removing jobs. One of the other more recent examples is in the case of Galapagos just this week , where CEO Paul Stoffels cut 200 jobs in order to move the company “forward, faster.”

Acquisition

23 Oct 2022

·www.otsuka.co.jp

Avanir Pharmaceuticals, Inc. Business Will Be Integrated

Otsuka America Pharmaceutical, Inc. (OAPI), announces that it will integrate Avanir Pharmaceuticals into its business as of January 1, 2023. The move brings together the knowledge, capabilities and best practices of both companies to further advance solutions to treat central nervous system (CNS) disorders. Avanir and OAPI are both subsidiaries of OAI, a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd., a global healthcare company. "I'm extremely proud to have led this extraordinary team of dedicated employees over the past five years," said Wa'el Hashad, president and chief executive officer, Avanir Pharmaceuticals. "Avanir's spirit of innovation and excellence will live on at Otsuka and ensure the continued innovation that will bring hope to patients and families." "Avanir and Otsuka have always shared a deep commitment to advancing solutions that improve the lives of patients and their caregivers. We welcome every new employee to the Otsuka family and know each will continue to make an impact on the communities we serve," said Tarek Rabah, president and CEO, Otsuka North America Pharmaceutical Business (OAPI). "This integration will bring greater opportunities to develop treatments for those impacted by CNS disorders." Founded in 1988 as Lidak Pharmaceuticals, the company became Avanir Pharmaceuticals in 1998 and launched their flagship product, Nuedexta (dextromethorphan hydrobromide and quinidine sulfate). Acquired by Otsuka in 2015, Avanir has been at the forefront of developing and delivering groundbreaking pharmaceutical treatments for people with CNS conditions. About Avanir Pharmaceuticals, Inc. Avanir Pharmaceuticals, Inc. is a pharmaceutical company committed to delivering innovative central nervous system (CNS) solutions to improve the lives of patients and their care communities. For more information about Avanir, visit https://www.avanir.com. Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy, "Otsuka-people creating new products for better health worldwide."

100 Deals associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Dextromethorphan Hydrobromide/Quinidine Sulfate	N07XX59	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pseudobulbar Palsy	US	Avanir Pharmaceuticals, Inc.	29 Oct 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
pseudobulbar affect	Phase 3	NO	Jenson Pharmaceutical Services Limited	24 Jun 2013
Diabetic Neuropathies	Phase 3	US	Avanir Pharmaceuticals, Inc.	-
pseudobulbar affect	Phase 2	IS	Jenson Pharmaceutical Services Limited	24 Jun 2013
pseudobulbar affect	Phase 2	LI	Jenson Pharmaceutical Services Limited	24 Jun 2013
pseudobulbar affect	Phase 1	EU	Jenson Pharmaceutical Services Limited	24 Jun 2013
Amyotrophic Lateral Sclerosis	Discovery	AR	Avanir Pharmaceuticals, Inc.	01 Dec 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAN2019	Not Applicable	pseudobulbar affect	86	Dextromethorphan-Quinidine (Nuedexta)	emridwlror(mtffdfqagf) = skezxtgrcs qdrmtxitdb (zmcbalhuqp, -3.30 to 5.22)	-	09 Apr 2019
NCT02176018 (CTgov)	Phase 2	Migraine Disorders	76	Dextromethorphan (Nuedexta)	avkafawmlr(pebffilwcd) = xlfkjybedi owjsvevgow (lpcbroybqq, bajrqybohp - abshibmjpw) View more	-	03 Apr 2018
NCT02176018 (CTgov)	Phase 2	Migraine Disorders	76	Placebo (Placebo)	avkafawmlr(pebffilwcd) = fshrqxafzx owjsvevgow (lpcbroybqq, uxypqjjtdt - osctvazhfl) View more	-	03 Apr 2018
NCT01767129 (CTgov)	Phase 2	Parkinson Disease \| Dyskinesia, Drug-Induced	14	AVP-923-45 (AVP-923-45)	xoyhsfyhrl(waopgrvpms) = dxmdortfyg ibfmovyrzj (zvqmtecmqx, zjzpmmfboc - mglufsrtnl) View more	-	29 Apr 2022
NCT01767129 (CTgov)	Phase 2	Parkinson Disease \| Dyskinesia, Drug-Induced	14	Placebo (Placebo)	xoyhsfyhrl(waopgrvpms) = yapffceliz ibfmovyrzj (zvqmtecmqx, xpaiugvffw - wslgiopsiu) View more	-	29 Apr 2022
NCT00021697 (Pubmed)	Phase 3	pseudobulbar affect	140	AVP-923 (30 mg of DM plus 30 mg of Q)	ocbuuedife(vqhhlwhxmy) = hehupeigsd zvmrfsdvwx (znwlevejlu )	Positive	26 Oct 2004
NCT01799941 (PRISM II, Pubmed \| CNS Spectr)	Phase 4	pseudobulbar affect	134	Dextromethorphan/quinidine 20/10 mg	(onjeornkii) = zwkpixoiho ewxaforfjq (zylpinzkng ) View more	-	01 Dec 2016
NCT00573443 (CTgov)	Phase 3	Amyotrophic Lateral Sclerosis \| pseudobulbar affect \| Multiple Sclerosis	326	Placebo	asfvxolvxb(qntfvqfbre) = ptlpmztwrj asuxbbhipc (iutkrzhfvl, ddskevopyt - uhndpzgtht) View more	-	10 Jul 2013
NCT01324232 (CTgov)	Phase 2	Multiple Sclerosis \| Neuralgia	209	Placebo (Placebo)	umzwsuvjif(adixwifnfu) = igdzbopcbi groariesap (pwskoueiex, igqwlvqreh - cdzddaclui) View more	-	22 Nov 2021
NCT01324232 (CTgov)	Phase 2	Multiple Sclerosis \| Neuralgia	209	AVP-923-20 (AVP-923-20)	umzwsuvjif(adixwifnfu) = ijrastklxe groariesap (pwskoueiex, fbtuieozfw - outerllzqu) View more	-	22 Nov 2021
NCT00056524 (Pubmed \| Curr Med Res Opin)	Phase 3	pseudobulbar affect	553	Dextromethorphan/Quinidine 30/30 mg	(tlxrlitlnf) = Serious AEs (SAEs) were reported in 126 patients (22.8%), including 47 deaths, mostly due to ALS progression and respiratory failure icrawgacyo (uecczmdqab )	-	01 Nov 2014
NCT01882829 (CTgov)	Phase 2	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	20	dextromethorphan/quinidine	(ycscfhlihz) = adnreaovfh futxfrojme (hvnqojoktx, ktcvbayvtv - lpyihsywjb) View more	-	11 Jun 2018
AAN2014	Phase 3	pseudobulbar affect	-	Dextromethorphan 20 mg/Quinidine 10 mg	fhhjtqxiac(oufiedhicl) = ivwddlpmpx vrrsltcpil (dgprvdoilj )	Positive	08 Apr 2014
AAN2014	Phase 3	pseudobulbar affect	-	Placebo	fhhjtqxiac(oufiedhicl) = evcaflowwt vrrsltcpil (dgprvdoilj )	Positive	08 Apr 2014

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