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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
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 | ||
2023/08/15 | Phase 1 | Completed | |||
2023/02/13 | Phase 2 | Recruiting | Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude |
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 |
---|---|---|---|---|---|
Paroxetine Hydrochloride Tablets | 国药准字H20031106 | 化学药品 | 片剂 | 8/23/2024 | |
Paroxetine Hydrochloride Tablets | 国药准字H20133084 | 化学药品 | 片剂 | 10/25/2022 | |
Paroxetine Hydrochloride Tablets | 国药准字H20243196 | 化学药品 | 片剂 | 2/20/2024 | |
Paroxetine Hydrochloride Tablets | 国药准字H10950043 | 化学药品 | 片剂 | 4/23/2020 | |
Paroxetine Hydrochloride Tablets | 国药准字H20040533 | 化学药品 | 片剂 | 5/12/2020 | |
Paroxetine Hydrochloride Tablets | 国药准字H20213120 | 化学药品 | 片剂 | 2/2/2021 | |
Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 国药准字H20243637 | 化学药品 | 缓释制剂 | 4/30/2024 | |
Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 国药准字H20243634 | 化学药品 | 片剂 | 4/30/2024 | |
Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 国药准字H20203422 | 化学药品 | 片剂 | 8/12/2020 | |
Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 国药准字H20249181 | 化学药品 | 片剂 | 10/22/2024 |
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 |