Overview
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) drug commonly known as Paxil. It has a variety of uses, including the treatment of anxiety disorders, major depression, posttraumatic stress disorder, and symptoms of menopause, among others. It was approved by the FDA in the early 1990s and marketed by SmithKline Beecham. A unique feature of this drug is that it is highly potent and selective in its inhibition of serotonin reuptake and has little effect on other neurotransmitters. Because of its potent inhibition of serotonin reuptake, paroxetine is more likely to cause withdrawal effects upon cessation. Paroxetine is well tolerated in most patients with a similar adverse effect profile to other members of its drug class. The controlled release formulation was designed to decrease the likelihood of nausea that is sometimes associated with paroxetine.
Indication
Paroxetine is indicated for the management of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder. One form of paroxetine, commercially known as Brisdelle, is used to manage mild to moderate vasomotor symptoms of menopause. Off-label, paroxetine may be used for the treatment of premature ejaculation or irritable bowel syndrome (IBS).
Associated Conditions
- Generalized Anxiety Disorder
- Irritable Bowel Syndrome (IBS)
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Post Traumatic Stress Disorder (PTSD)
- Premature Ejaculation
- Premenstrual Dysphoric Disorder (PMDD)
- Social Anxiety Disorder (SAD)
- Vasomotor Symptoms Associated With Menopause
Research Report
A Comprehensive Monograph on Paroxetine: Pharmacology, Clinical Profile, and Comparative Analysis
Section 1: Drug Identification and Physicochemical Properties
This section establishes the fundamental identity of paroxetine, detailing its chemical nomenclature, structural properties, and the various salt formulations that are critical to understanding its clinical applications and research context.
1.1 Nomenclature and Identifiers
Paroxetine is a well-established small molecule drug belonging to the selective serotonin reuptake inhibitor (SSRI) class of antidepressants.[1] Its generic name is recognized internationally, with variants including Paroxetina and Paroxetinum.[1] Chemically, it is classified as a phenylpiperidine derivative and contains several key functional groups, including a benzodioxole, an organofluorine compound, and an aromatic ether, and is functionally related to monofluorobenzene.[2]
The precise chemical structure is defined by its stereochemistry, with the biologically active form being the (−)-(3S,4R)-diastereomer.[2] This specificity is reflected in its formal IUPAC (International Union of Pure and Applied Chemistry) names:
(−)-(3S,4R)-4-(p-fluorophenyl)-3-((3,4-(methylenedioxy)phenoxy)methyl)piperidine and (3S-trans)-3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine.[1]
For unambiguous identification across scientific and regulatory databases, paroxetine is assigned a series of unique identifiers. The most prominent of these are:
- DrugBank ID: DB00715 [1]
- CAS (Chemical Abstracts Service) Number: 61869-08-7 for the parent base molecule [1]
- PubChem Compound ID (CID): 43815 [3]
Additional identifiers facilitate cross-referencing in various databases, including ChEBI (CHEBI:7936), ChEMBL (CHEMBL490), KEGG (D02362), and the FDA UNII code (41VRH5220H).[2] During its development, it was also known by research codes such as BRL 29060 and FG-7051.[1]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/05/22 | Phase 1 | Completed | |||
2015/03/02 | Phase 3 | Terminated | |||
2014/12/19 | N/A | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | ||
2014/10/31 | Phase 3 | Completed | |||
2014/10/23 | Phase 4 | UNKNOWN | Si Tianmei | ||
2014/10/15 | Phase 1 | Completed | |||
2014/09/12 | Phase 4 | UNKNOWN | HolsboerMaschmeyer NeuroChemie GmbH | ||
2014/07/16 | Phase 4 | Completed | Capital Medical University | ||
2014/06/26 | Phase 1 | Completed | |||
2014/03/26 | Phase 1 | Completed | Forest Laboratories |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
State of Florida DOH Central Pharmacy | 53808-0752 | ORAL | 30 mg in 1 1 | 5/29/2010 | |
Physicians Total Care, Inc. | 54868-6178 | ORAL | 12.5 mg in 1 1 | 12/9/2011 | |
Oxford Pharmaceuticals, LLC | 69584-673 | ORAL | 30 mg in 1 1 | 6/1/2022 | |
Sebela Pharmaceuticals Inc. | 54766-203 | ORAL | 30 mg in 1 1 | 8/31/2023 | |
Physicians Total Care, Inc. | 54868-3526 | ORAL | 30 mg in 1 1 | 1/5/2012 | |
Oxford Pharmaceuticals, LLC | 69584-671 | ORAL | 10 mg in 1 1 | 6/1/2022 | |
Sebela Pharmaceuticals Inc. | 54766-201 | ORAL | 10 mg in 1 1 | 8/31/2023 | |
State of Florida DOH Central Pharmacy | 53808-0750 | ORAL | 20 mg in 1 1 | 5/29/2010 | |
Padagis US LLC | 0574-0279 | ORAL | 7.5 mg in 1 1 | 2/28/2022 | |
Mylan Pharmaceuticals Inc. | 0378-7001 | ORAL | 10 mg in 1 1 | 2/27/2024 |
EMA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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UK EMC Drug Information
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