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] A randomized, open-label, single-dose, two-formulation, double-crossover bioequivalence study of dextromethorphan hydrobromide and quinidine sulfate capsules 20 mg/10 mg in humans under fasting and fed conditions

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]

Primary objective: To study the bioequivalence of the two preparations in healthy subjects by taking a single oral dose of the test preparation dextromethorphan hydrobromide quinidine sulfate capsules (specification: 20mg/10mg) and the reference preparation dextromethorphan hydrobromide quinidine sulfate capsules (trade name: Nuedxta®, specification: 20mg/10mg) in the fasting and postprandial state, and to provide a basis for the sample size calculation of the formal trial. Secondary objective: To observe the safety of the test preparation dextromethorphan hydrobromide quinidine sulfate capsules and the 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.

01 Sep 2024·Biomedical Chromatography

A validated stability‐indicating reversed‐phase‐UPLC method for simultaneous estimation of promethazine hydrochloride, methylparaben, propylparaben and sodium benzoate assay of cough suppressant and antihistamine liquid oral dosage forms

Article

Author: Nekkalapudi, Arjuna Rao ; Komreddy, Venugopal Reddy ; Pippalla, Sreenivas

AbstractA quick, simple, sensitive, efficient and stability‐indicating reverse‐phase ultraperformance liquid chromatographic method for the estimation of propylparaben, methylparaben and sodium benzoate in a pharmaceutical liquid oral formulation was developed. A Waters Acquity UPLC BEH C18, 50 × 2.1 mm, 1.7 μm i.d. column was used to perform chromatographic separation with a 0.1% perchloric acid mobile phase used as solvent A and a mixture of 0.1 % perchloric acid and methanol in the ratio 20:80 (v/v), respectively, as solvent B. The experiments were carried out at a flow rate of 0.4 ml/min and the detection wavelength was 240 nm. The compartment temperature of the column was set at 40°C and the injection volume was set at 2 μl. The main aim of the research was to develop a single UPLC assay method for promethazine (active ingredient) and preservatives in the oral solution of promethazine HCl and dextromethorphan HBr that contains promethazine (active ingredient) and methylparaben, propylparaben and sodium benzoate (preservatives). An assay of dextromethorphan HBr was developed and validated by another HPLC method. The drug and preservatives were eluted at retention times of 19.3 min for promethazine HCl, 9.3 min for methylparaben, 18.9 min for propylparaben and 8.9 min for sodium benzoate. Validation of the developed method was carried out as stated by the International Conference on Harmonization guidelines ICH Q2B and under USP<1225>. The analytical parameters verified specificity/selectivity, linearity, accuracy, ruggedness and robustness. The linearity ranges of promethazine HCL, methylparaben, propylparaben and sodium benzoate were 10–100, 10–80, 1.0–8.0 and 10–80 μg/ml, respectively, with a correlation coefficient of active ingredients and preservatives of 1.00. Percentage recoveries of promethazine, propylparaben, methylparaben, and sodium benzoate were 100.0–100.2, 99.0–100.3, 99.5–98.0 and 99.0–100.0%. The validated analytical method proves that the method is specific, precise, linear, accurate, sensitive, rugged and stable, indicating the quantification of the active ingredient and all preservatives in liquid oral formulations.

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.

News (Medical) associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

24 May 2024

·www.fiercepharma.com

Fierce Pharma Asia—AstraZeneca eyes China's innovation, plots Singapore ADC plant; FDA rejects Hengrui's PD-1 drug

AstraZeneca made multiple headlines related to Asia this week. In addition, the FDA's rejection of Hengrui's PD-1 inhibitor made our news roundup. AstraZeneca's CEO wants to tap into China's innovation explosion. The company inked an oncology antibody deal with Harbour BioMed, and it plans to build a $1.5 billion ADC plant in Singapore. Hengrui and Elevar's proposed PD-1/VEGFR liver cancer combination has been rejected by the FDA. Plus more. 1. AstraZeneca to harness China's explosion of innovation to boost cell therapy R&D Innovation in China has “exploded,” and AstraZeneca plans to utilize its growing presence in the country to boost its R&D ambitions in cell therapy, CEO Pascal Soriot said during an investor event. Clinical development of cell therapy in China can “move much faster than anywhere else in the world,” he said. The British pharma has made several deals with Chinese companies over the past two years, including its $1 billion acquisition of Gracell Biotechnologies. 2. AstraZeneca pays $19M to Harbour BioMed's Nona for preclinical cancer antibodies Speaking of tapping into China’s innovation, AstraZeneca paid Harbour BioMed’s U.S. subsidiary Nona Biosceicnes $19 million upfront for preclinical monoclonal antibodies as potential targeted cancer therapies. Nona’s mice-based technology can produce heavy chain-only antibodies. The deal also includes $10 million in near-term payments and another $575 million in biobucks. 3. AstraZeneca places $1.5B bet on end-to-end ADC manufacturing in Singapore Meanwhile, AZ has unveiled plans to build a $1.5 billion antibody-drug conjugate manufacturing facility in Singapore. The site, expected to be operational by 2029, will become the company’s first end-to-end ADC production site. The move comes shortly after CEO Soriot said AZ is building separate drug supply chains for China and Western countries amid geopolitical risks. In recent years, Singapore has become a hot destination for biopharma manufacturing expansions. 4. FDA snubs another China-made PD-1 with rejection of Elevar, Hengrui's liver cancer combo The FDA has rejected Jiangsu Hengrui Pharma and Elevar Therapeutics’ respective applications for PD-1 inhibitor camrelizumab and the VEGFR inhibitor rivoceranib for use as a combination in first-line liver cancer. The FDA cited unresolved issues from the inspection of Hengrui’s manufacturing facility for camrelizumab as well as unfinished clinical trial site inspections. The partners aim to refile as soon as possible. 5. Takeda gets crafty with $1.2B biobucks deal to create molecular glues with Degron Takeda has signed a $1.2 billion biobucks deal with Shanghai’s Degron Therapeutics to work on molecular glue degraders for multiple targets in oncology, neuroscience and inflammation. Degron will use its GlueXplorer platform to find the new glues for therapeutic targets selected by Takeda. Degron has an in-house pipeline, including five early-stage molecular glue candidates in oncology. 6. Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial Otsuka has officially ended development of AVP-786 after the NMDA receptor antagonist failed to move the needle in agitation associated with Alzheimer’s disease in a phase 3 trial. Otsuka obtained the drug from its $3.5 billion acquisition of Avanir Pharmaceuticals in 2015, which also gave the Japanese pharma Nuedexta for the rare disorder pseudobulbar affect. 7. Merck KGaA unit avoids DOJ prosecution after exposing scheme to divert drugs to China Two Florida residents pleaded guilty to conspiring to “fraudulently procure deeply discounted products” from Merck’s KGaA’s Sigma-Aldrich and ship them to China using faked export documents. The Department of Justice decided not to prosecute the German firm’s life science division, MilliporeSigma, because the company quickly disclosed the scheme and cooperated with the government’s investigation. 8. Chinese CDMO Asymchem expands footprint with deal to take over former Pfizer UK site China’s Asymchem Laboratories inked a deal to purchase a former Pfizer small molecule API pilot plant and part of its development labs in Sandwich, England. As part of a bigger cost-cutting scheme, Pfizer last year laid off 500 staffers at the plant. The purchase marks Asymchem’s first foray into Europe, and the firm expects to hire 100 workers by the end of the year, including many former Pfizer employees. Other News of Note: 9. Bristol Myers lines up Opdivo treatment in Pakistan, Rwanda and beyond as part of 10-year access campaign 10. Astellas, Yaskawa Electric Corporation ink pact to explore automated cell therapy production 11. Serum Institute deploys first doses of Oxford, Novavax-partnered malaria shot to Africa 12. No treachery here: Celltrion signs 'The Traitors' star Mollie Pearce for bowel disease campaign

AcquisitionPhase 3Cell TherapyLicense out/inADC

23 May 2024

·www.pharmaceutical-technology.com

Otsuka cuts development for AVP-786 following Phase III flop

Otsuka Pharmaceuticals ended clinical development for AVP-786 for agitation associated with Alzheimer’s disease following a negative Phase III readout. Credit: SOPA Images via Getty Images. Otsuka Pharmaceutical has axed the development of its dementia drug, AVP-786, following a disappointing Phase III readout (NCT03393520). Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The Japanese company was investigating the therapy as a potential treatment for patients with agitation associated with dementia due to Alzheimer’s disease (AD). Otsuka completed the recent Phase III study in December 2023, reporting the official study results in February 2024. In the randomised, double-blind study, AVP-786 demonstrated no significant difference in the primary endpoint of mean change in the Cohen-Mansfield Agitation Inventory total score compared to the placebo. As per the 22 May press release, the decision to terminate the drug’s development followed a complete data analysis of the Phase III trial. AVP-786 is a dextromethorphan/quinidine combination that works by antagonising NMDA receptors and agonising Sigma-1 receptors amongst other effects. The therapy is a second-generation treatment, derived from Avanir Pharmaceuticals ’ Nuedexta (AVP-923). Otsuka acquired Avanir in a $3.5bn deal in December 2014. Nuedexta is a first-in-class dual-action glutamate inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including multiple sclerosis, in December 2010. Otsuka is the developer of the only FDA-approved treatment for the agitation associated with dementia due to AD, Rexulti (brexpiprazole), which received approval in November 2023. See Also: Pfizer starts $1.5bn cost-cutting initiative amidst declining Covid-19 revenues Patients and caregivers driving innovation in drug development According to GlobalData, there are seven therapies in Phase III trials for dementia associated with Alzheimer’s disease. This includes trials studying Auvelity— Axsome Therapeutics bupropion / dextromethorphan combination therapy, and Novo Nordisk ’s semaglutide. Novo Nordisk’s drug is approved for the treatment of weight loss and diabetes, under the brand names Wegovy and Ozempic. Pharma companies are actively trying to push the scope of these GLP-1 receptor agonists , with trials now exploring them as treatments for neurological disorders and fatty liver disease. Novo Nordisk predicts that the Phase III AD trial with semaglutide will be completed in October 2026. GlobalData is the parent company of Pharmaceutical Technology. As per the recent press release, Otsuka has declared that it will continue developing therapies for agitation associated with AD. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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Phase 3Drug ApprovalClinical ResultNDAPhase 2

22 May 2024

·www.fiercepharma.com

Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial

After coming up short in a phase 3 trial for the second time, Otsuka has discontinued development of AVP-786. The drug was under investigation as a therapy for agitation that can accompany Alzheimer's disease. Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on measures of agitation associated with dementia. The results were originally issued in February, with Otsuka reporting that AVP-786 did not achieve the primary endpoint that measured a change in baseline on a rating scale of agitation compared with placebo. The therapy had been under development through Otsuka’s U.S. subsidiaries for agitation associated with dementia due to Alzheimer's. At the time, Otsuka did not have full details of the study to present. In announcing the termination of AVP-786 today, the Japanese pharma is still keeping those details under wraps. AVP-786 has traveled a bumpy path through the clinic, including failing a different phase 3 trial in 2019. That disappointment for the NMDA receptor antagonist came just months after Otsuka posted positive results for AVP-786 in a separate phase 3 trial. Otsuka acquired AVP-786 from CNS specialist Avanir Pharmaceuticals in a 2015 buyout worth $3.5 billion. Also coming in that deal was Nuedexta, a treatment approved in 2010 for pseudobulbar affect (PBA), a rare disorder that causes outbursts of laughing or crying that accompany some neurological conditions. Nuedexta uses the same chemical compound—dextromethorphan hydrobromide and quinidine sulfate—as AVP-786. Otsuka also investigated AVP-786 in early-stage trials for intermittent explosive disorder, schizophrenia and traumatic brain injury.

Phase 3AcquisitionClinical ResultDrug ApprovalPhase 2

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	LI	Jenson Pharmaceutical Services Limited	24 Jun 2013
pseudobulbar affect	Phase 3	EU	Jenson Pharmaceutical Services Limited	24 Jun 2013
pseudobulbar affect	Phase 3	NO	Jenson Pharmaceutical Services Limited	24 Jun 2013
pseudobulbar affect	Phase 3	IS	Jenson Pharmaceutical Services Limited	24 Jun 2013
Amyotrophic Lateral Sclerosis	Phase 3	US	Avanir Pharmaceuticals, Inc.	01 Jan 2001
Emotional lability	Phase 3	US	Avanir Pharmaceuticals, Inc.	01 Jan 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P6-3.008 (AAN2024)	Not Applicable	Huntington Disease	20	Dextromethorphan/Quinidine 20mg/10mg	(ddpygjmdce) = pltixjukmk nopcuvuyzv (yxkoyoybrk )	Negative	09 Apr 2024
				Placebo	(ddpygjmdce) = sscjxrogot nopcuvuyzv (yxkoyoybrk )
NCT01767129 (LID in PD, CTgov)	Phase 2	Dyskinesia, Drug-Induced \| Parkinson Disease	14	AVP-923-45 (AVP-923-45)	fgiddrhwky(olagqlmauy) = jyjwfniyuk mhkuwlyyxp (gmhmxtmfxu, qpupxuewvq - yqpmoqeztv) View more	-	29 Apr 2022
				Placebo (Placebo)	fgiddrhwky(olagqlmauy) = viqmprvhcs mhkuwlyyxp (gmhmxtmfxu, wqvagjqmev - fwecjzezvn) View more
NCT01584440 (CTgov)	Phase 2	Alzheimer Disease \| Agitation	220	Placebo (Placebo)	nnceqcrbvl(fuwbevleoe) = fkqymnfuqk weznehhbuy (ysunqantjb, xjqfybgacf - kfuocudgln) View more	-	26 Nov 2021
				AVP-923-20 (AVP-923)	nnceqcrbvl(fuwbevleoe) = fgiqruflnz weznehhbuy (ysunqantjb, mnjtvelwag - cfbkypzwbg) View more
NCT01324232 (PRIME, CTgov)	Phase 2	Multiple Sclerosis \| Neuralgia	209	Placebo (Placebo)	hzmxrsirbl(nstfgatjkl) = ibbncrcwce ylhyvkwyhw (fhylzqtxmr, rhuczjvvzz - vefcfvsdtv) View more	-	22 Nov 2021
				AVP-923-20 (AVP-923-20)	hzmxrsirbl(nstfgatjkl) = ulzyefppwm ylhyvkwyhw (fhylzqtxmr, oiiyodtgfw - yaskiezuir) View more
AAN2019	Not Applicable	pseudobulbar affect	86	Dextromethorphan-Quinidine (Nuedexta)	eionuwymeq(nduwyuyvkp) = htvaaooalf droskbvdfm (fwoxghhrgn, -3.30 to 5.22)	-	09 Apr 2019
NCT01882829 (CTgov)	Phase 2	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	20	dextromethorphan/quinidine	(vdfcnnlfpy) = umjxcwqlix ulruibleor (yufrltqjro, fxawonveak - viudzngknm) View more	-	11 Jun 2018
NCT02176018 (CTgov)	Phase 2	Migraine Disorders	76	Dextromethorphan (Nuedexta)	ldwguswqsb(wswrvfgisz) = bpbvlvdojc ozidpnxxsr (jqutkcnecg, gxdxaqzfjt - ofciuklral) View more	-	03 Apr 2018
				Placebo (Placebo)	ldwguswqsb(wswrvfgisz) = ubifhpglay ozidpnxxsr (jqutkcnecg, ociaoncptj - jxpleuztvy) View more
NCT01630811 (Nuedexta, CTgov)	Phase 2	Autistic Disorder \| Autism Spectrum Disorder	13	Nuedexta (Nuedexta)	gpptdzrsob(ozgsxnliro) = qdkezermza axrxxdnntq (angpdlyatt, pjjnnvitwz - ayptdkndml) View more	-	08 Dec 2017
				Placebo (Placebo)	gpptdzrsob(ozgsxnliro) = dpsssaixwr axrxxdnntq (angpdlyatt, tvypnkblyy - fpgctvqxqu) View more
NCT01799941 (PRISM II, Pubmed \| CNS Spectr)	Phase 4	pseudobulbar affect	134	Dextromethorphan/quinidine 20/10 mg	(xhrgotlpep) = vnexsbosfs mcqitmumdy (zxlgiiunzl ) View more	-	01 Dec 2016
NCT01799941 (PRISM II, AAN2016)	Phase 4	pseudobulbar affect	367	Dextromethorphan 20 mg/Quinidine 10 mg (NUEDEXTA®)	prnkbhlnnd(hdwghbmeoc) = pggaidpwyy vakfilztvs (lwxctivbue )	Positive	05 Apr 2016

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