Delving into the Latest Updates on Venlafaxine Hydrochloride with Synapse

Overview

Basic Info

SummaryVenlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI), targeting the serotonin transporter (SERT-5) and norepinephrine transporter (NET), both of which are responsible for regulating the delicate balance of these neurotransmitters in the brain. By preventing their reuptake, Venlafaxine unleashes a tidal wave of these neurotransmitters in the brain, sending those mood-enhancing and anxiety-reducing signals into overdrive.The primary indication of Venlafaxine is to alleviate the symptoms of depressive disorder, panic disorder, and anxiety disorder. On December 28, 1993, the FDA approved Wyeth Corp's Venlafaxine . Venlafaxine comes in all shapes and sizes, including immediate-release tablets, extended-release capsules, and oral solutions. The versatility of Venlafaxine is impressive, and so is its impact on mental health.

Drug Type

Small molecule drug

Synonyms

Dobupal, Efexor XR, Effexor SR

+ [26]

Target

NET x SERT

Mechanism

Norepinephrine reuptake inhibitors, Serotonin reuptake inhibitors

Therapeutic Areas

Other Diseases

Active Indication

Anxiety DisordersDepressive Disorder, MajorPanic Disorder+ [3]

Inactive Indication

AnxietyDepression

Originator Organization

Pfizer Inc.

Active Organization

BGP Pharma ULCUpjohn US 2 LLCOsmotica Pharmaceutical US LLC

+ [3]

Inactive Organization

Pfizer Inc.

Jiangsu Hansoh Pharmaceutical Co. Ltd.

Viatris, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

US (28 Dec 1993),

Depressive Disorder

RegulationPriority Review (CN)

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Structure

Molecular FormulaC17H28ClNO2

InChIKeyQYRYFNHXARDNFZ-UHFFFAOYSA-N

CAS Registry99300-78-4

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

Start Date31 Jul 2024

Sponsor / Collaborator

Universität Stuttgart

NCT04977271 / Not yet recruitingPhase 4IIT

Serotonin-Norepinephrine Reuptake Inhibitors for the Prevention and Treatment of Pain, Depression, and Anxiety in Patients With Head & Neck Cancer

The purpose of this research study is to initiate a pharmacotherapy protocol for at-risk patients with newly diagnosed head and neck cancer in order to decrease the incidence of anxiety, depression, and uncontrolled pain during cancer treatment.

Start Date28 Jul 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

100 Clinical Results associated with Venlafaxine Hydrochloride

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100 Translational Medicine associated with Venlafaxine Hydrochloride

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100 Patents (Medical) associated with Venlafaxine Hydrochloride

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4,390

Literatures (Medical) associated with Venlafaxine Hydrochloride

30 Dec 2024·Acta neurologica Taiwanica

Taste Disorder and Tongue Numbness After Lithium Overdose.

Article

Author: Chu, Si-Yu ; Wang, Huang-Chi ; Hsieh, Ming-Hong ; Chang, Cheng-Chen

PURPOSE:

Drug-induced taste disturbances are prevalent in clinical practice, with dysgeusia being a frequent manifestation. This study aims to present a case of taste disorders and tongue numbness induced by a lithium overdose.

CASE REPORT:

A 33-year-old woman with bipolar II disorder attempted suicide by ingesting multiple drugs, including lithium and benzodiazepines. She exhibited weakness but was conscious after admission. Laboratory analyses indicated elevated serum lithium and urine benzodiazepine levels. Admitted to a psychiatric ward, her symptoms included diarrhea, poor appetite, and postprandial nausea. Two weeks later, she reported altered taste sensations and tongue numbness following the overdose. Her ongoing medication included venlafaxine, valproate sodium, and clozapine. Symptoms improved over time without specific treatment, aligning with increased appetite and weight gain.

CONCLUSION:

Drug-induced taste disturbances have a substantial impact on patients' quality of life and medication adherence. This case brings attention to taste disorders induced by lithium and suggests potential mechanisms that could contribute to taste alterations. It underscores the importance of conducting thorough assessments in patients experiencing gustatory symptoms, particularly during the ongoing pandemic.

01 Apr 2024·Journal of affective disorders

Omega-3 polyunsaturated fatty acids supplementation improves memory in first-diagnosed, drug-naïve patients with depression: Secondary analysis of data from a randomized controlled trial

Article

Author: Zhao, Tingyu ; Wang, Lu ; Tang, Hui ; Chen, Jindong ; Tang, Mimi ; Xie, Kaiqiang ; Xue, Ying ; Guo, Jimin ; Liu, Ting

INTRODUCTION:

Cognitive impairments are found in most patients with major depressive disorder (MDD). It is believed that low Omega-3 polyunsaturated fatty acids (n-3 PUFAs) level raise the risk of anxiety, depressive symptoms and cognition dysfunction. Since our previous research has found n-3 PUFAs supplementation improves anxiety in MDD, this study was to further explore the effectiveness on cognitive impairment among depressed patients.

METHODS:

A total of 72 venlafaxine treated outpatients with first-diagnosed, drug-naïve depression were enrolled. Daily n-3 PUFAs supplementation (2.4 g/d of fish oil, including 1440 mg eicosapentaenoic acid and 960 mg of docosahexaenoic acid) or placebo was used for 12 weeks. Cognitive function, measure by repeatable battery for the assessment of neuropsychological status ([RBANS]) scores, was compared over time.

RESULTS:

Immediate memory, delayed memory and RBANS total scores were significant higher in both groups at week 4 and week 12 compared with baseline. Both groups exhibited improvement on attention scores at week 12. No significant differences were observed comparing n-3 PUFAs with placebo groups in the improvement of total RBANS scores and other subscales except in the change of immediate memory at both week 4 and week 12 (p < 0.05).

LIMITATIONS:

Sample size was relatively low. Moreover, multiple ethnic populations and the income of patients should be considered. Lastly, we used raw scores instead of the standardized scores of RBANS.

CONCLUSION:

N-3 PUFAs supplementation yielded a small but statistically significant improvement on immediate memory in first-diagnosed, drug-naïve depressed patients. While, antidepressant treatment resulted in significant improvement of cognitive function.

01 Feb 2024·European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

A posterior-alpha ageing network is differentially associated with antidepressant effects of venlafaxine and rTMS

Article

Author: Sack, Alexander T ; Niemegeers, Peter ; Arns, Martijn ; van Dijk, Hanneke ; Meijs, Hannah ; Van Hecke, Jan ; De Wilde, Bieke ; Luykx, Jurjen J ; Gordon, Evian ; Voetterl, Helena

Major depressive disorder (MDD) is a highly prevalent psychiatric disorder, but chances for remission largely decrease with each failed treatment attempt. It is therefore desirable to assign a given patient to the most promising individual treatment option as early as possible. We used a polygenic score (PGS) informed electroencephalography (EEG) data-driven approach to identify potential predictors for MDD treatment outcome. Post-hoc we conducted exploratory analyses in order to understand the results in depth. First, an EEG independent component analysis produced 54 functional brain networks in a large heterogeneous cohort of psychiatric patients (n = 4,045; 5-84 yrs.). Next, the network that was associated to PGS for antidepressant-response (PRS-AR) in an independent sample (n = 722) was selected: an age-related posterior alpha network that explained >60 % of EEG variance, and was highly stable over recording time. Translational analyses were performed in two other independent datasets to examine if the network was predictive of psychopharmacotherapy (n = 535) and/or repetitive transcranial magnetic stimulation (rTMS) and concomitant psychotherapy (PT; n = 186) outcome. The network predicted remission to venlafaxine (p = 0.015), resulting in a normalized positive predicted value (nPPV) of 138 %, and rTMS + PT - but in opposite direction for women (p = 0.002) relative to men (p = 0.018) - yielding a nPPV of 131 %. Blinded out-of-sample validations for venlafaxine (n = 29) and rTMS + PT (n = 36) confirmed the findings for venlafaxine, while results for rTMS + PT could not be replicated. These data suggest the existence of a relatively stable EEG posterior alpha aging network related to PGS-AR that has potential as MDD treatment predictor.

15

News (Medical) associated with Venlafaxine Hydrochloride

14 Jun 2024

·www.prnewswire.com

Carella, Byrne, Cecchi, Brody & Agnello, P.C.* Announces the Settlement of a Class-Action Lawsuit Involving Persons and Entities that Purchased, Paid For, and/or Provided Reimbursement for Effexor XR® and/or its Generic Equivalent

*In association with Wexler Boley & Elgersma LLP, Spector Roseman & Kodroff, P.C., Miller Law LLC, Motley Rice LLC, Quantum Legal LLC, and The Dugan Law Firm, PLC CHICAGO, June 14, 2024 /PRNewswire/ -- Legal Notice Did You Purchase, Pay for, or Provide Reimbursement for Effexor XR® and/or Its Generic Equivalent? You Could Get Money from a Settlement There is a Settlement in a class-action lawsuit with Wyeth (also known as Wyeth LLC and formerly known as Wyeth, Inc. and American Home Products); Wyeth Pharmaceuticals, Inc.; Wyeth-Whitehall Pharmaceuticals; and Wyeth Pharmaceuticals Company (collectively, "Wyeth") and Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (collectively, "Teva"). The lawsuit claims that Wyeth and Teva unlawfully kept generic versions of Effexor XR® off the market, causing consumers and third-party payors to pay more for brand and generic Effexor XR® than they should have. Wyeth and Teva deny they did anything wrong. There has been a settlement with Wyeth; the lawsuit against Teva is ongoing. No one is claiming that Effexor XR® is unsafe. Who is included in the Settlement? You may be included in the Settlement if you are a person or entity that purchased, paid for, and/or reimbursed some or all of the cost of Effexor XR® or AB-rated generic versions of Effexor XR® for yourself, your family, or your members, employees, insureds, participants, or beneficiaries, from June 14, 2008 through May 31, 2011, in the following states: Arizona, California, Florida, Kansas, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nevada, New Hampshire, New Mexico, New York, North Carolina, Oregon, Rhode Island, South Dakota, Tennessee, West Virginia, and Wisconsin. A more detailed notice, including the full class definition and who is not included, is available at . What does the Settlement provide? Wyeth will pay $25.5 million into a Settlement Fund that will pay (1) money to eligible Class Members; (2) notice and administration costs; (3) service awards to the class representatives who brought the lawsuit; and (4) attorneys' fees, costs, and expenses. How can I get a payment? You must submit a valid claim form to apply for payment from the Settlement Fund. The amount of your payment will depend on the amount of Effexor XR® or AB-rated generic versions of Effexor XR® you purchased and the number of claims that are filed. The Claim Forms, and information on how to submit them, are available at . Claim forms must be postmarked (if mailed) or received (if submitted online) on or before September 16, 2024. What are my rights? Even if you do nothing, you will be bound by the Court's decisions. If you want to keep your right to sue Wyeth yourself, you must exclude yourself by July 29, 2024. If you do not exclude yourself, you may object to the Settlement by July 29, 2024. Detailed instructions about how to act on these rights are available at . The Court will hold a hearing on September 12, 2024 to consider whether to approve the Settlement, a request for attorneys' fees of up to 34% of the Settlement Fund, plus costs and expenses, and service awards to the class representatives. You or your own lawyer may appear and speak at the hearing at your own expense. The Court may change these deadlines or the hearing date and time. Check the website below for updates. Please do not call the Court or the Clerk of the Court for information about the Settlement. For more information: 1-877-933-2882 SOURCE Carella, Byrne, Cecchi, Brody & Agnello, P.C.; Wexler Boley & Elgersma LLP

Patent Infringement

07 Jun 2024

·www.drugs.com

1 in 6 Patients Who Quit Antidepressants Get 'Discontinuation Symptoms'

FRIDAY, June 7, 2024 -- Roughly 1 in 6 people who stop taking an antidepressant will experience symptoms caused by discontinuing the drug, a new review finds. However, only 1 in 35 will experience severe symptoms after dropping their medication, researchers report June 5 in The Lancet Psychiatry journal. “Our study confirms that a number of patients coming off antidepressants will experience discontinuation symptoms, and for a few, these will be of a more severe extent,” said lead researcher Dr. Jonathan Henssler , a psychiatrist with Charité – Universitätsmedizin Berlin in Germany. However, Henssler added in a journal news release that the findings “should also provide reassurance that rates of discontinuation symptoms are not as high as some previous single studies and reviews have suggested.” Previous studies have estimated that more than half of patients experience symptoms when stopping antidepressants, and that half the symptoms are severe, researchers said in background notes. To get a more accurate picture, researchers reviewed data from 79 studies involving more than 21,000 patients. Looking at all the data, the researchers found that about a third (31%) of people who stopped taking an antidepressant experienced at least one symptom. These symptoms could include dizziness, headache, nausea, insomnia and irritability. The overall data also showed that severe symptoms occurred in about 3% of patients, or 1 in 35. However, when looking at results from randomized controlled clinical trials -- considered the gold standard for medical research -- about 17% of patients experienced symptoms even though they were only taking a placebo rather than an actual antidepressant. This suggests that about half of all symptoms reported might be due to negative expectations -- what the researchers call the “nocebo effect” -- or from other health problems unrelated to antidepressant use. Therefore, the researchers concluded that one in six patients (15%) will actually experience symptoms directly caused by halting antidepressant use. Anyone wanting to stop taking antidepressants should talk with their doctor, researchers said. Certain antidepressants carry a higher risk of severe symptoms once they’re stopped, results show. These include imipramine (Tofranil), paroxetine (Paxil) and venlafaxine (Effexor). “Our findings do not imply that some symptoms experienced by people during antidepressant discontinuation are not ‘real’ or that all discontinuation symptoms are due to expectations on the part of patients,” said senior researcher Christopher Baethge , with the University of Cologne. “Any symptoms that cause patients discomfort or distress should be taken seriously, and the patient should be supported. The patient and clinician should discuss which of the symptoms might be directly caused by stopping antidepressants and how best to manage all symptoms," Baethge added. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

06 Jun 2024

·www.drugs.com

Several Drugs Linked to Risk for Aneurysmal Subarachnoid Hemorrhage

THURSDAY, June 6, 2024 -- Several commonly prescribed drugs are associated with aneurysmal subarachnoid hemorrhage (aSAH), according to a study published online June 5 in Neurology . Jos P. Kanning, from the University Medical Center Utrecht in the Netherlands, and colleagues conducted a drug-wide association study to examine the association between commonly prescribed drugs and aSAH incidence. Use of commonly prescribed drugs was examined across exposure windows (current, within three months; recent, three to 12 months; and past, >12 months). Exposure to 205 commonly prescribed drugs was investigated among 4,879 aSAH cases and 43,911 matched controls. The researchers found similar trends for lisinopril and amlodipine, with a decreased risk for aSAH in association with current use, while the risk for aSAH was increased with recent use. The risk for aSAH was reduced with current use of simvastatin, metformin, and tamsulosin. Increased aSAH risk was seen in association with current use of warfarin, venlafaxine, prochlorperazine, and co-codamol. "Future research should use a more hypothesis-driven approach to further investigate these associations and differentiate between drug class and specific drug substance effects," the authors write. "In addition, this research may help identify additional risk factors for aSAH, potentially leading to new pharmacologic therapy options for aneurysmal management." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

100 Deals associated with Venlafaxine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00821	Venlafaxine Hydrochloride	N06AX16	DB00285

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anxiety Disorders	CA	BGP Pharma ULC	04 Mar 1998
Panic Disorder	CA	BGP Pharma ULC	04 Mar 1998
Phobia, Social	CA	BGP Pharma ULC	04 Mar 1998
Generalized anxiety disorder	US	Upjohn US 2 LLC	20 Oct 1997
Depressive Disorder, Major	CA	Wyeth Canada ULC	31 Dec 1994
Depressive Disorder	US	Wyeth Pharmaceuticals LLC	28 Dec 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anxiety	Phase 3	BE	Viatris, Inc.	01 Mar 2005
Anxiety	Phase 3	CA	Viatris, Inc.	01 Mar 2005
Anxiety	Phase 3	FR	Viatris, Inc.	01 Mar 2005
Anxiety	Phase 3	IE	Viatris, Inc.	01 Mar 2005
Anxiety	Phase 3	IT	Viatris, Inc.	01 Mar 2005
Anxiety	Phase 3	NL	Viatris, Inc.	01 Mar 2005
Anxiety	Phase 3	ES	Viatris, Inc.	01 Mar 2005
Anxiety	Phase 3	SE	Viatris, Inc.	01 Mar 2005
Depression	Phase 3	JP	Wyeth AB	01 Dec 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04639193 (CTgov)	Phase 2	Sleep Apnea, Obstructive	20	Acetazolamide+Eszopiclone (Dual-Therapy)	ctvpmusloa(pdxijlwpxj) = bcnpjatdvk fytadpmasf (kiwxoxqnmq, bwhwlxnpvt - gwlqulotwl) View more	-	02 May 2024
				Placebo+Acetazolamide+Eszopiclone (Placebo)	ctvpmusloa(pdxijlwpxj) = ytfdxfognr fytadpmasf (kiwxoxqnmq, jtsfwkemnv - mnaecoczhq) View more
NCT00974155 (Pubmed \| J Clin Psychopharmacol)	Phase 4	Depressive Disorder, Major	234	Venlafaxine	jneckizjxe(zueboglsut) = The most frequent ADRs during treatment with VF were orthostatic dizziness (15.8%) ifyxndrwya (rudkbxcpom ) View more	-	16 Nov 2020
NCT03588572 (CTgov)	Not Applicable	Aphasia \| Ischemic stroke	43	Venlafaxine hydrochloride capsules (Venlafaxine Group)	wcwfuuogrs(ugwqkjrkcr) = vzkwojjqtu xdhevgeygo (lhdjrzvphv, txsqlrlqkr - gftcqusnxq) View more	-	03 Oct 2019
				venlafaxine (Controlled Group)	wcwfuuogrs(ugwqkjrkcr) = zelopqzlxd xdhevgeygo (lhdjrzvphv, tchsuvjpci - zlfpaidqce) View more
NCT01611155 (CTgov)	Not Applicable	Peripheral Nervous System Diseases \| Neuropathy	50	placebo	ggjoxvqvgy(lhsamlfobr) = ibpjeoesux tjinamfnpe (dsqjujjxim, wqwacggrjk - enrxgsgdwe) View more	-	26 Sep 2019
NCT02407704 (CTgov)	Phase 4	Depressive Disorder, Major \| Depression	31	Venlafaxine XR (Aerobic Exercise + Venlafaxine XR (60-79 Years of Age))	upzyssxszu(jkivnijcpc) = xbjqtuywvz jxpvhndzbe (uprcdjijya, jokxxlooip - pvzznrizmj) View more	-	23 May 2018
				Venlafaxine XR (Venlafaxine XR Only (60-79 Years of Age))	upzyssxszu(jkivnijcpc) = jrltbufxvn jxpvhndzbe (uprcdjijya, rdqxqxgfjr - zluvbxmfws) View more
P5.326 (AAN2018)	Phase 3	Fibromyalgia	163	Venlafaxine	okrazqjrkt(ldocdtvkvi): P-Value = 0.033	Positive	10 Apr 2018
				Gabapentin
NCT01609348 (DIADs-3, CTgov)	Not Applicable	Alzheimer Disease \| Depressive Disorder \| Depression	5	Venlafaxine (Venlafaxine)	dnpjudvzfd(cvrkxejsud) = iazebcxyjv jtejfpbiga (xxwofxlzjn, pnavbwedjh - lwxfqxiodw) View more	-	31 Jan 2018
				Placebo (Sugar Pill)	dnpjudvzfd(cvrkxejsud) = pcfovotmqz jtejfpbiga (xxwofxlzjn, aatoykdesx - jhinjyagnp) View more
NCT00354432 (CTgov)	Phase 3	Vasomotor symptom \| Hot Flashes \| Prostatic Cancer	120	Placebo Pill (Arm I - Placebo)	oaobqwfokq(pbgwnmrfsg) = ijboepedzu mzzgutcbyw (oxdhsoogbj, lqgthsumrd - kgbbzpgzxm) View more	-	18 May 2017
				oral soy protein/isoflavones powder (Arm II - Soy)	oaobqwfokq(pbgwnmrfsg) = xyuszorakn mzzgutcbyw (oxdhsoogbj, clxmicapcs - yelzuivboh) View more
NCT00620776 (CTgov)	Phase 2	Generalized anxiety disorder	69	Cognitive Behavioral Therapy+Venlafaxine XR	fsghjstokm(ttcpwkzovw) = ibuojpdmnl fosvinypjq (lgdbskokcw, jeqmyhqiww - gvcbffgmrq) View more	-	16 Feb 2017
NCT00892047 (IRL GREY, CTgov)	Phase 4	Depressive Disorder \| Depression	468	aripiprazole+venlafaxine (1: Venlafaxine Plus Aripiprazole)	loypzkytek(wzyycwhehz) = xchectfend ignzfkpjsd (lhlgfkpazb, vyvjkyewui - tfthzpzysw) View more	-	17 Dec 2015
				venlafaxine plus placebo (2: Placebo Comparator)	loypzkytek(wzyycwhehz) = qjhpzqgxob ignzfkpjsd (lhlgfkpazb, yfwjwzziou - abbrvdtlhi) View more