Last update 14 Dec 2024

Atomoxetine Hydrochloride

Last update 14 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryAtomoxetine, a diminutive molecule drug concocted by Eli Lilly, procured its inaugural medical approval in 2002. The drug functions as an inhibitor of norepinephrine reuptake in the brain, inducing augmented levels of norepinephrine in the synaptic cleft. The drug's primary indication is for Attention Deficit Disorder with Hyperactivity (ADHD), a disorder typified by inattentiveness, impulsivity, and hyperactivity. Atomoxetine is postulated to operate by enhancing focus and concentration in individuals grappling with ADHD. Taking everything into account, atomoxetine's intricate mechanism of action and clinical indications proffer it as a valuable therapeutic option for those affected by ADHD.

Drug Type

Small molecule drug

Synonyms

(-)-Tomoxetine, Atomoxetine, Atomoxetine hydrochloride (JAN/USP)

+ [9]

Target

NET

Mechanism

NET inhibitors(Norepinephrine transporter inhibitors)

Therapeutic Areas

Other Diseases

Active Indication

Attention Deficit Disorder With Hyperactivity

Inactive Indication

Alzheimer DiseaseAttention Deficit and Disruptive Behavior DisordersAttention Deficit Disorder+ [9]

Originator Organization

Eli Lilly & Co.

Active Organization

Eli Lilly Australia Pty Ltd.Lilly SA

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (26 Nov 2002),

Attention Deficit Disorder With Hyperactivity

RegulationPriority Review (CN), Orphan Drug (US)

Structure

Molecular FormulaC17H22ClNO

InChIKeyLUCXVPAZUDVVBT-UNTBIKODSA-N

CAS Registry82248-59-7

236

Clinical Trials associated with Atomoxetine Hydrochloride

NCT06573970 / Not yet recruitingPhase 4IIT

Atomoxetine Effect on Attention, Executive Function, and Quality of Life in Veterans With Posttraumatic Stress Disorder

Attention deficits (AD) frequently co-occur with posttraumatic stress disorder (PTSD). The presence of AD is associated with greater PTSD clinical severity and poorer clinical outcomes. Knowledge regarding the mechanism underlying this association is limited, though the emerging evidence has indicated that executive function deficit (EFD) is strongly correlated with AD and PTSD symptoms. While treatments developed for PTSD have existed for years, a substantial portion of individuals do not fully respond to conventional treatment. Accumulating evidence suggest that attention deficit (AD) and EFD may be a driving force for PTSD treatment resistance. However, treatment of executive impairment in PTSD is very limited. As a result, untreated co-occurring AD and EFD in PTSD poses severe negative impacts on patients' functional recovery, treatment outcomes, and quality of life (QoL). Given that up to 50% of patients do not respond well to the first-line pharmacological PTSD treatments, it is imperative to seek novel treatment strategies to improve EF that may improve both standard treatment response and QoL, social function. The proposed study directly addresses this knowledge gap by testing the efficacy of atomoxetine (ATX) in improving EF and attention among Veterans with PTSD, which will further improve Veterans' QoL and social function. ATX represents a promising novel candidate pharmacotherapy for individuals with PTSD. ATX is a non-stimulant selective norepinephrine reuptake inhibitor (SNRI), approved by the FDA for the treatment of ADHD. Studies suggest that ATX, unlike stimulants, lacks addictive properties and shows efficacy in the treatment of comorbid depression and anxiety, which is ideal in the treatment of PTSD. Data from the investigators' preliminary study provides encouraging support for the therapeutic potential of ATX in improving EF in Veterans with comorbid PTSD/ADHD. The investigators' recent research uncovered a higher rate of ADHD among Veterans with PTSD, and the comorbid AD symptoms were correlated with PTSD severity and poorer treatment outcomes. Treatment with ATX showed significant symptoms reduction in ADHD and improvement in inhibitory function in Veterans with ADHD/PTSD. In the proposed study, the investigators will focus on ATX in improvement of EF and attention, and further psycho-social life function and QoL. The investigators will (1) employ a randomized, double-blind design that will consist of 12 weeks of treatment with ATX or placebo medication; (2) use standardized, repeated dependent measures to rigorously assess AD and EFD symptomatology; (3) measure impairment in associated mental and behavioral health problems (e.g., attention deficit, depression, anxiety, suicidality, QoL, family/social functioning); and (4) use response inhibition task GoNogo, working memory and attention tests Digit Span and Trail Making to investigate the underlying pathophysiology of PTSD and prognostic indicators of treatment outcome. To achieve these goals, the investigators have assembled a multidisciplinary team with expertise in PTSD, ADHD clinical trials, and human laboratory paradigms who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The proposed project is directly responsive to the mission of the VA-RRD "to maximize Veterans' functional independence, quality of life and participation in their lives and community." Successful completion of this study will provide a platform for a large multi-center trial to further confirm the important role of EF in PTSD treatment outcomes. The findings from this study will provide critically needed evidence to help inform clinical practice guidelines on the treatment of PTSD. The outcome of the proposed research will be significant, because it provides a knowledge base to allow for development of new PTSD intervention strategies. More importantly, this clinical trial may immediately benefit Veterans by enhancing their cognitive function, reducing AD related disability, and further improving quality of life for Veterans who suffer from PTSD.

Start Date16 Dec 2024

Sponsor / Collaborator

VA Office of Research and Development

[+1]

NCT06295562 / Not yet recruitingPhase 4IIT

Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

This study will conduct 3 intervention trials with 44 different participants in each trial, with 22 participants will undergo in-laboratory overnight polysomnograms (PSGs) at one night of medication intervention, and the other 22 at taking placebo (contained starch) 1 h before sleep. Three medication regimens will be tested: (1) atomoxetine 80mg combined with oxybutynin 5mg; (2) venlafaxine 37.5mg; and (3) atomoxetine 80mg combined with trazodone 100mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.

Start Date14 Oct 2024

Sponsor / Collaborator

China Medical University Hospital

NCT06542887 / Not yet recruitingPhase 2IIT

Efficacy and Safety of Black Seed Oil as Adjunctive Therapy in Pediatrics With Attention-Deficit/Hyperactivity Disorder

Attention-Deficit/Hyperactivity Disorder is one of the most prevalent neuropsychiatric disorders affecting children with known persistence into adulthood in about 60% of patients. The mainstay treatment for ADHD is the pharmacological treatment involving stimulants (methylphenidate, amphetamines) and non-stimulants (atomoxetine, guanfacine, clonidine). Although these options have been found to be effective, these agents may not always be promising, as a proportion of patients may not respond or may not be able to tolerate their adverse events. Thus, increasing studies are exploring alternative therapies for ADHD, focusing on the neuroprotective effects of dietary and natural compounds like antioxidants that can be serving as an alternative or supplement to classical treatment with fewer side effects. Oxidative stress and neuroinflammation have been extensively addressed in ADHD and several studies on antioxidants in pediatrics with ADHD have shown promising results in improving symptoms and reducing scores on ADHD questionnaires.
Black seed oil (BSO) has shown anti-inflammatory and antioxidant properties in several human studies. Also numerous in-vitro studies have shown that nigella sativa possesses neuroprotective effects that are attributed to its antioxidant and anti-inflammatory effects. Thymoquinone (TQ) possesses the majority of nigella sativa oil (NSO) therapeutic benefits with the ability to target the central nervous system owing to its low molecular weight and lipophilic nature. In rats, thymoquinone administration significantly improved cognition by enhancing cholinergic function, synaptic plasticity, and attenuating oxidative damage and neuroinflammation, as shown by increased SOD and TAC and reduced MDA, NO, TNF-α immunoreactivity, and AChE activities. Previous human studies suggested that nigella sativa can stabilize mood, reduce anxiety, and regulate cognition, attention, and memory. In a previous animal study on ADHD mice model, Nigella sativa oil showed a reduction in inattention and hyperactivity with lower glutamate levels, and also showed higher recognition memory, glutathione peroxidase levels, dopamine levels, and neuronal density compared to the ethanol group only.

Start Date01 Oct 2024

Sponsor / Collaborator

Ain Shams University

100 Clinical Results associated with Atomoxetine Hydrochloride

100 Translational Medicine associated with Atomoxetine Hydrochloride

100 Patents (Medical) associated with Atomoxetine Hydrochloride

1,891

Literatures (Medical) associated with Atomoxetine Hydrochloride

01 Dec 2024·Journal of Attention Disorders

Risk of Periodontitis in Adolescents With Attention Deficit Hyperactivity Disorder: A Cohort Study of 81,055 Participants

Article

Author: Bai, Ya-Mei ; Chen, Mu-Hong ; Tsai, Shih-Jen ; Huang, Kai-Lin ; Chen, Li-Chi ; Lo, Wen-Liang ; Chen, Tzeng-Ji ; Su, Tung-Ping ; Hsu, Ju-Wei

Objectives::

Previous studies have demonstrated poor oral hygiene in children with attention deficit hyperactivity disorder (ADHD). However, the association between ADHD and periodontitis is still unclear.

Methods::

In all, 16,211 adolescents with ADHD and 162,110 age- and sex-matched controls participated in the study between 2001 and 2011. To identify the occurrence of periodontitis, the participants were followed up till the end of 2011. Confounding factors, including smoking, diabetes, and depressive disorder, were assessed and adjusted in the Cox regression models.

Results::

Adolescents with ADHD ( HR: 2.29) were more likely to develop periodontitis later in life than controls. We additionally observed the beneficial effect of atomoxetine ( HR: 0.42) on the periodontitis risk among adolescents with ADHD. However, this finding should be interpreted cautiously given the small sample ( n = 290) of children taking atomoxetine in the present study.

Conclusions::

ADHD is an independent risk factor for subsequent periodontitis development. Oral health should be closely monitored in adolescents with ADHD. Future investigation of the shared pathomechanisms between periodontitis and ADHD is warranted.

01 Dec 2024·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Development of a fluorescent nano-sensing probe for atomoxetine analysis: Additional clinical pharmacokinetic study

Article

Author: Abduljabbar, Maram H ; Alosaimi, Manal E ; Alzhrani, Rami M ; Ramzy, Sherif ; Almalki, Atiah H ; Saeed, Salma

Atomoxetine is a psychostimulant drug used for the treatment of attention-deficit/hyperactivity disorder (ADHD) symptoms in people with autism. Herein, eco-friendly fluorescent carbon quantum dots (CQDs) were synthesized using black-eyed pea beans and characterized for the purpose of quantifying atomoxetine in pharmaceutical capsules and human plasma. The selectivity of these CQDs towards atomoxetine was improved by functionalizing their surface with an atomoxetine-tetraphenylborate ion complex. The quantification of atomoxetine is based on measuring the fluorescence quenching of the functionalized CQDs in response to varying concentrations of atomoxetine. The Stern-Volmer plot was employed to investigate the mechanism through which atomoxetine quenches the fluorescence intensity of the CQDs. The outcomes indicated a dynamic quenching mechanism. The applied method was optimized and validated in compliance with ICH requirements, resulting in excellent linearity across the concentration range of 50-800 ng/mL. The developed method was successfully used to quantify atomoxetine in pharmaceutical dosage form and human plasma with acceptable accuracy and precision outcomes. In addition, the method was applied for clinical pharmacokinetic study of atomoxetine in the plasma of children diagnosed with both autism and ADHD. Atomoxetine was rapidly absorbed after a single oral dose of 10 mg, reaching maximum concentration within two hours and having a half-life (t_1/2) of 3.11 h. Moreover, the method demonstrates a notable degree of eco-friendliness, as evidenced by two greenness evaluation metrics; Green Analytical Procedure Index (GAPI) and Analytical GREEnness (AGREE).

01 Dec 2024·CLINICAL AUTONOMIC RESEARCH

Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial

Article

Author: Ding, Tan ; Martinez, Jose ; Biaggioni, Italo ; Kaufmann, Horacio ; Mwesigwa, Naome ; Palma, Jose-Alberto ; Kirabo, Annet ; Shibao, Cyndya A ; Black, Bonnie ; Millar Vernetti, Patricio

Abstract:

Purpose:

We previously reported that single doses of the norepinephrine transporter inhibitor, atomoxetine, increased standing blood pressure (BP) and ameliorated symptoms in patients with neurogenic orthostatic hypotension (nOH). We aimed to evaluate the effect of atomoxetine over four weeks in patients with nOH.

Methods:

A randomized, double-blind, placebo-controlled crossover clinical trial between July 2016 and May 2021 was carried out with an initial open-label, single-dose phase (10 or 18 mg atomoxetine), followed by a 1-week wash-out, and a subsequent double-blind 4-week treatment sequence (period 1: atomoxetine followed by placebo) or vice versa (period 2). The trial included a 2-week wash-out period. The primary endpoint was symptoms of nOH as measured by the orthostatic hypotension questionnaire (OHQ) assessed at 2 weeks.

Results:

A total of 68 patients were screened, 40 were randomized, and 37 completed the study. We found no differences in the OHQ composite score between atomoxetine and placebo at 2 weeks (−0.3 ± 1.7 versus −0.4 ± 1.5; P = 0.806) and 4 weeks (−0.6 ± 2.4 versus −0.5 ± 1.6; P = 0.251). There were no differences either in the OHSA scores at 2 weeks (3 ± 1.9 versus 4 ± 2.1; P = 0.062) and at 4 weeks (3 ± 2.2 versus 3 ± 2.0; P = 1.000) or in the OH daily activity scores (OHDAS) at 2 weeks (4 ± 3.0 versus 5 ± 3.1, P = 0.102) and 4 weeks (4 ± 3.0 versus 4 ± 2.7, P = 0.095). Atomoxetine was well-tolerated.

Conclusions:

While previous evidence suggested that acute doses of atomoxetine might be efficacious in treating nOH; results of this clinical trial indicated that it was not superior to placebo to ameliorate symptoms of nOH.

Trial registration:

ClinicalTrials.gov; NCT02316821.

News (Medical) associated with Atomoxetine Hydrochloride

23 Oct 2024

·www.prnewswire.com

Apnimed Strengthens Executive Team and Board of Directors with the Appointment of Two Biopharmaceutical Industry Veterans

Senior financial executive Ramzi Benamar joins leadership team as Chief Financial Officer Experienced board member, Chief Financial Officer and strategic consultant Gary Sender joins board of directors to Chair the Finance Committee Both appointments precede multiple value-creating catalysts, including Phase 3 results for AD109 as a first potential oral treatment for obstructive sleep apnea (OSA) CAMBRIDGE, Mass., Oct. 23, 2024 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company focused on discovery, development, and commercialization of first-in-class oral therapies that address the neuromuscular dysfunction of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced the appointments of Ramzi Benamar as Chief Financial Officer and Gary Sender to the Board of Directors and as Chair of the Finance committee. The strengthening of both the leadership team and Board of Directors brings decades of combined experience in critical functions, such as financial management, strategic planning, company capitalization, investor relations and corporate mergers and acquisitions. "We are pleased to welcome both Ramzi and Gary to Apnimed, as they bring proven leadership experience in leading-edge, science-driven companies, across a broad range of critical finance and strategic functions. I am confident their additions will help to continue to drive forward our financial strategy, deliver on key operational priorities, and build long-term shareholder value," said Larry Miller, MD, Chief Executive Officer of Apnimed. "These appointments come at a critical time, as we look forward to next year's Phase 3 clinical trial results for AD109 and preparation for its potential commercial launch as a once-nightly oral therapy for OSA." Mr. Benamar commented, "I am incredibly excited to join the Apnimed team during this transformational time for the company. With its ongoing, late-stage clinical development program for AD109 in OSA, a value generating joint-venture with Shionogi and a strong existing investor base, Apnimed is well-positioned to serve the needs of all stakeholders, and I look forward to contributing to the achievement of its next phase of growth." "Apnimed is in an excellent position to accelerate into the next stage of corporate development," noted Mr. Sender. "I am eager to contribute to the financial and strategic initiatives of the company and am confident in the organization's continued clinical and future commercial successes." About Ramzi Benamar, Chief Financial Officer Ramzi Benamar has over 25 years of experience in the biotech and pharma industry, where he has an extensive track record of supporting the development and commercialization of novel pharmaceutical products and serving in executive financial leadership roles in both public and private companies. Ramzi has led several rounds of financing as a CFO amounting to about $600M. He served as the CFO of BELLUS Health, where he contributed to the growth of the company toward its acquisition by GSK. Ramzi was also the CFO at DBV Technologies and Elucida, and Vice President and Head of Financial Planning and Analysis for Spark Therapeutics until its acquisition by Roche Holdings. Earlier in his career, Ramzi held numerous positions of increasing responsibilities in finance, strategy, and operations at various pharma companies including Shire, Johnson & Johnson, and Merck. He holds a bachelor's and master's degree in business administration from Temple University, and a master's degree from the University of the Sciences in Philadelphia (Saint Joseph's University). About Gary Sender, Independent Director and Chair of Finance Committee Gary Sender has extensive financial leadership experience across the biopharmaceutical industry, including serving on the board of directors of several public and private biotechnology companies. Mr. Sender joined the Board of Directors of both Schrödinger, Inc., and Harmony Biosciences when they were both private companies and currently Chairs both respective Audit Committees and the Schrödinger Compensation Committee. He currently Chairs the Audit Committee and serves on the Compensation Committee of iBio. Mr. Sender also joined the Board of Directors of Gennao Bio (Private) in September of 2021 and currently Chairs both the Audit and Compensation committees. In March 2021, Mr. Sender retired as the Chief Financial Officer of Nabriva plc. Prior to Nabriva, he was the Chief Financial Officer of Synergy Pharmaceuticals. Previously, Mr. Sender was the Senior Vice President of Finance for Shire plc, supporting its global commercial businesses and all functions of its specialty pharmaceuticals business. Prior to joining Shire, he was the Chief Financial Officer of Tengion, Inc. Earlier in his career, Mr. Sender held several increasingly senior finance-related roles, including a 15-year career at Merck & Co., Inc., most recently serving as Vice President and Controller for Merck's U.S. pharmaceuticals business. Mr. Sender earned his bachelor's degree in finance and management information systems from Boston University. He received his master's degree in industrial administration (MBA) with a concentration in Finance from Carnegie-Mellon University. About AD109 AD109 could be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the underlying neuromuscular cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective noradrenaline reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. AD109 is a once-nightly oral pill that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109 may be a simple solution to help improve oxygenation and health wellbeing for people living with OSA. About Obstructive Sleep Apnea Obstructive sleep apnea is a serious chronic sleep-related breathing disease where the upper airway repeatedly collapses during sleep, causing intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. The impact of OSA spans age, sex, and body type—there is no single face of the disease. Every night, greater than 54 million people in the U.S. and 1 billion people worldwide with OSA stop breathing, exposing them to serious, long-term health risks. An individual with OSA can experience hundreds of sleep apnea events in a single night. Each sleep apnea event reduces blood oxygen levels and deprives cells of the energy they need to perform vital functions. Ultimately, failure to effectively treat OSA increases the risk of long-term health consequences and quality of life impacts, including daytime fatigue, impaired judgement, premature death, and severe and potentially life-threatening health complications, such as high blood pressure, cardiovascular disease, and type 2 diabetes. Yet, even after being diagnosed, the majority of people with OSA either refuse, abandon, or underutilize treatment. In addition, no currently available treatments address the underlying neuromuscular dysfunction present in all OSA cases. About Apnimed Apnimed is a pharmaceutical company dedicated to breathing new life into the sleep-related breathing disease treatment landscape. The company envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and elevate the health and expectations of everyone in the sleep-related breathing disease community. Based in Cambridge, Mass., Apnimed is advancing a focused pipeline of oral pharmaceutical product candidates designed to help improve oxygenation for people living with obstructive sleep apnea and beyond, to other sleep-related breathing diseases, including several that are part of our joint venture with Shionogi & Co., Ltd, Shionogi Apnimed Sleep Science (SASS). Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Brian Ritchie [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive Change

26 Sep 2024

·www.prnewswire.com

Apnimed to Participate in the 4th Annual Needham Private Biotech Company Virtual 1x1 Forum

CAMBRIDGE, Mass., Sept. 26, 2024 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company focused on discovery, development, and commercialization of first-in-class oral therapies that address the neuromuscular dysfunction of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced that the company will be participating in the 4th Annual Needham Private Biotech Company Virtual 1x1 Forum taking place on October 8-9, 2024. Apnimed will be virtually hosting investor meetings on Tuesday, October 8th. About AD109 AD109 could be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the underlying neuromuscular cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective noradrenaline reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. AD109 is a once-nightly oral pill that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109 may be a simple solution to help improve oxygenation and health wellbeing for people living with OSA. About Obstructive Sleep Apnea Obstructive sleep apnea is a serious chronic sleep-related breathing disease where the upper airway repeatedly collapses during sleep, causing intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. The impact of OSA spans age, sex, and body type—there is no single face of the disease. Every night, greater than 54 million people in the U.S. and 1 billion people worldwide with OSA stop breathing, exposing them to serious, long-term health risks. An individual with OSA can experience hundreds of sleep apnea events in a single night. Each sleep apnea event reduces blood oxygen levels and deprives cells of the energy they need to perform vital functions. Ultimately, failure to effectively treat OSA increases the risk of long-term health consequences and quality of life impacts, including daytime fatigue, impaired judgement, premature death, and severe and potentially life-threatening health complications, such as high blood pressure, cardiovascular disease, and type 2 diabetes. Yet, even after being diagnosed, the majority of people with OSA either refuse, abandon, or underutilize treatment. In addition, no currently available treatments address the underlying neuromuscular dysfunction present in all OSA cases. About Apnimed Apnimed is a pharmaceutical company dedicated to breathing new life into the sleep-related breathing disease treatment landscape. The company envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and elevate the health and expectations of everyone in the sleep-related breathing disease community. Based in Cambridge, Mass., Apnimed is advancing a focused pipeline of oral pharmaceutical product candidates designed to help improve oxygenation for people living with obstructive sleep apnea and beyond, to other sleep-related breathing diseases, including several that are part of our joint venture with Shionogi & Co., Ltd, Shionogi Apnimed Sleep Science (SASS). Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Brian Ritchie [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

12 Sep 2024

·www.echemi.com

India’s Generic Drug Blood Concentration Fails Standards—China Urgently Halts Production!

Studies have revealed that the application of Indian-made tomoxetine hydrochloride capsules in the Chinese market has failed to achieve the expected blood drug concentration, leading to the decision of China's National Healthcare Administration to suspend the import, sale and use of the drug. The original product of tomoxetine hydrochloride, a drug used to treat ADHD, has been discontinued in the Chinese market due to market competition. India's Dr Reddy's Laboratory, the country's third-largest generics maker, has suffered similar problems with its generic olanzapine. Olanzapine is mainly used for the treatment of acute bipolar mania, but there are difficulties in the conversion between the original drug and different generic drugs in the Chinese market. The study, conducted jointly by Xiangya Second Hospital and Ningbo Kangning Hospital, showed that patients switched from Chinese generic drugs to Indian generic drugs, and the blood drug concentration decreased significantly, which may have an impact on treatment effectiveness and drug safety. The researchers suggest that changes in efficacy and tolerance should be closely monitored during the conversion of generic drugs, and recommend that pharmaceutical companies disclose pharmacological and bioequivalence data and develop appropriate clinical evaluation and monitoring guidelines.

Biosimilar

100 Deals associated with Atomoxetine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02574	Atomoxetine Hydrochloride	N06BA09	DB00289

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	US	Eli Lilly & Co.	26 Nov 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 3	US	Eli Lilly & Co.	01 Nov 2005
Generalized anxiety disorder	Phase 3	-	Eli Lilly & Co.	01 Nov 2005
Neoplasms	Phase 3	US	Eli Lilly & Co.	01 Nov 2005
Phobia, Social	Phase 3	-	Eli Lilly & Co.	01 Nov 2005
Attention Deficit and Disruptive Behavior Disorders	Phase 3	AU	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	BE	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	DK	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	FI	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	DE	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	NL	Eli Lilly & Co.	01 Dec 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SFN2022	Not Applicable	-	-	Atomoxetine 0.3 mg/kg	vmatmzeocb(ngrtvbraqp) = odsmapbjpk bldtgdxzbw (gwbzovecup ) View more	-	13 Nov 2022
				Atomoxetine 1.0 mg/kg	vmatmzeocb(ngrtvbraqp) = tciwyucdin bldtgdxzbw (gwbzovecup ) View more
NCT00628394 (CTgov)	Phase 4	Schizophrenia	119	Atomoxetine (Atomox/CR)	ipwaoqxefn(ksqjyokfaw) = zarkrrxrrz yreqtxmbdt (iwkvvvwwvp, qgdttnthpv - vwaqofnycd) View more	-	25 Sep 2020
				Atomoxetine (Atomox/Control)	ipwaoqxefn(ksqjyokfaw) = bsfilqjeub yreqtxmbdt (iwkvvvwwvp, rfvqcflkki - rpqgquqqsh) View more
NCT01340885 (CTgov)	Phase 4	Cognitive Dysfunction \| Parkinson Disease	9	Strattera (Atomoxetine)	riduenvfmk(vitiwuvvcp) = kdbrjlqbou gjkqmwiett (jlokfhhkxu, bcvfgjuodi - uhuwjryjql) View more	-	07 Jul 2020
				Exelon (Rivastigimine)	riduenvfmk(vitiwuvvcp) = hdombxkrfj gjkqmwiett (jlokfhhkxu, kacxlejdmq - gsyiprpfqy) View more
NCT02500732 (POST6, CTgov)	Phase 2	Syncope, Vasovagal	57	Placebo (Placebo)	jbdcrcuxsm(trhagogbxw) = tupvbanrxb dvlfbxrjhl (tignrialbo, gpgtunoais - eioblzltyb) View more	-	21 Apr 2020
				Atomoxetine (Atomoxetine)	jbdcrcuxsm(trhagogbxw) = kzlgfcsqey dvlfbxrjhl (tignrialbo, zwmyyolksl - ceqkodcptj) View more
NCT00918567 (CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	56	Behavior Modification Therapy+atomoxetine (Combined Therapy)	opkmcqjogq(zdzzxymceg) = bhbqvbdqub gbdzznwuuj (yzjendyvpy, jfpzddeexj - omnkneyfmi) View more	-	07 Apr 2020
				atomoxetine (Drug Therapy)	opkmcqjogq(zdzzxymceg) = ukiabuupol gbdzznwuuj (yzjendyvpy, sjdwkaqrda - fhrkujunvz) View more
NCT03091400 (CTgov)	Phase 2	Amnesia, Anterograde \| Multiple Sclerosis	11	Atomoxetine (Atomoxetine)	ucwjnqaxlt(izrsvjlzyy) = wrahykqnea wncrftwvel (rsljudlauc, lnznfokowv - ayrjfhnmnd) View more	-	13 Mar 2020
				Placebo (Placebo)	ucwjnqaxlt(izrsvjlzyy) = tkcktdbugd wncrftwvel (rsljudlauc, jzxdfpmcyl - cfsomatjhy) View more
NCT01522404 (ATX-001, CTgov)	Phase 2	Mild cognitive disorder	39	Placebo+Atomoxetine (Atomoxetine / Inactive Compound)	ttkorulpwa(ugacxqkqks) = alyqkkytvi iydcyzagyc (leobzxaicm, rgourquaik - tdbhvigswg) View more	-	05 Dec 2018
				Placebo+Atomoxetine (Inactive Compound / Atomoxetine)	ttkorulpwa(ugacxqkqks) = gwqnxmjcej iydcyzagyc (leobzxaicm, kudbzqeccp - rsbnefmaku) View more
NCT01738191 (ATM-Cog, CTgov)	Phase 2	Cognitive Dysfunction \| Parkinson Disease	30	Atomoxetine (Atomoxetine)	zlujzjajlr(nunbwwmpgx) = yujsomgrjb cxohekrpjx (fxoxnkjjwd, mqtglhrbvw - ystgssqamy) View more	-	23 Aug 2018
				Placebo (Placebo)	zlujzjajlr(nunbwwmpgx) = wsduomzkmt cxohekrpjx (fxoxnkjjwd, lkdooetprq - uiuytimskl) View more
NCT00183391 (CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	232	Methylphenidate+Atomoxetine (Atomoxetine Then Methylphenidate)	dotnyappuy(wfgqokertd) = ypfgvotonk lkeuccpcvi (psclkzfdwr, uouobxuwtv - imhvemexsk) View more	-	06 Jun 2018
				Methylphenidate+Atomoxetine (Methylphenidate Then Atomoxetine)	dotnyappuy(wfgqokertd) = yiebpjqxav lkeuccpcvi (psclkzfdwr, doljfkrjkd - bhiafeqkyx) View more
NCT00286949 (CTgov)	Not Applicable	Parkinson Disease \| Impairment of Executive Functions	12	Atomoxetine	ccwjsshjsa(orgqetrhiv) = wignbfwbmh wcngdwlhsa (tznguaapaf, mcligogsov - tggqemwvsx) View more	-	18 Sep 2017

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