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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/17 | Not Applicable | Not yet recruiting | |||
2025/07/09 | Not Applicable | Not yet recruiting | |||
2025/01/29 | Phase 4 | Recruiting | |||
2025/01/08 | Phase 2 | Recruiting | |||
2024/01/30 | Phase 1 | Completed | Asceneuron S.A. | ||
2024/01/30 | Phase 3 | Recruiting | Mostafa Bahaa | ||
2024/01/12 | Phase 3 | Not yet recruiting | aya ramadan ashmawy sarhan | ||
2023/10/04 | Phase 1 | Completed | |||
2023/09/22 | N/A | Active, not recruiting | |||
2023/09/06 | Phase 3 | Recruiting | Federico II University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Lannett Company, Inc. | 62175-472 | ORAL | 37.5 mg in 1 1 | 10/4/2021 | |
Sebela Pharmaceuticals Inc. | 54766-202 | ORAL | 20 mg in 1 1 | 8/31/2023 | |
Preferred Pharmaceuticals, Inc | 68788-0797 | ORAL | 10 mg in 1 1 | 11/2/2023 | |
Apotex Corp | 60505-4518 | ORAL | 20 mg in 1 1 | 12/25/2023 | |
Preferred Pharmaceuticals, Inc | 68788-9074 | ORAL | 20 mg in 1 1 | 11/2/2023 | |
Sebela Pharmaceuticals Inc. | 54766-204 | ORAL | 40 mg in 1 1 | 8/31/2023 | |
State of Florida DOH Central Pharmacy | 53808-0754 | ORAL | 40 mg in 1 1 | 5/29/2010 | |
Rhodes Pharmaceuticals L.P. | 42858-705 | ORAL | 25 mg in 1 1 | 9/30/2023 | |
Rhodes Pharmaceuticals L.P. | 42858-703 | ORAL | 12.5 mg in 1 1 | 9/30/2023 | |
Physicians Total Care, Inc. | 54868-1819 | ORAL | 25 mg in 1 1 | 12/9/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Apo-Paroxetine 20mg Tablet | SIN13485P | TABLET, FILM COATED | 20.0mg | 7/10/2008 | |
SEROXAT CR TABLET 25 mg | SIN12583P | TABLET, EXTENDED RELEASE | 25mg | 8/30/2004 | |
SEROXAT CR TABLET 12.5 mg | SIN12584P | TABLET, EXTENDED RELEASE | 12.5 mg | 8/30/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
EXTINE 10 paroxetine (as hydrochloride) 10 mg tablet bottle | 120728 | Medicine | A | 7/26/2006 | |
NOUMED PAROXETINE paroxetine (as hydrochloride) 20 mg tablet blister pack | 308493 | Medicine | A | 11/7/2018 | |
EXTINE 30 paroxetine (as hydrochloride) 30 mg tablet blister pack | 120731 | Medicine | A | 7/26/2006 | |
EXTINE 10 paroxetine (as hydrochloride) 10 mg tablet blister pack | 120725 | Medicine | A | 7/26/2006 | |
PAXTINE paroxetine 20mg (as hydrochloride) tablet blister pack | 227120 | Medicine | A | 10/24/2014 | |
PHARMACOR PAROXETINE 20 paroxetine 20mg (as hydrochloride) tablets blister pack | 130628 | Medicine | A | 3/12/2007 | |
EXTINE20 paroxetine (as hydrochloride) 20 mg tablet bottle | 120730 | Medicine | A | 7/26/2006 | |
Paroxetine (as hydrochloride) 20mg tablet-film coated (AF) bulk | 81478 | Medicine | A | 1/14/2002 | |
PAROXETINE GH paroxetine (as hydrochloride) 20mg tablet blister pack | 219043 | Medicine | A | 12/18/2014 | |
PAROXETINE HYDROCHLORIDE TABLETS 30mg (AF) bulk. | 109211 | Medicine | A | 9/20/2004 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
DAPAROX 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Angelini Pharma Espana S.L. | 65259 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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