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
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2011/06/10 | N/A | Completed | |||
2011/06/10 | N/A | Completed | |||
2011/06/10 | N/A | Completed | |||
2011/06/10 | N/A | Completed | |||
2011/06/07 | Phase 1 | Completed | |||
2011/05/26 | Phase 3 | Completed | |||
2011/05/16 | Phase 1 | Completed | |||
2011/04/20 | Phase 1 | Completed | |||
2010/05/25 | Phase 4 | Completed | |||
2010/01/14 | Phase 3 | Completed | Central Institute of Mental Health, Mannheim |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Chartwell RX, LLC | 62135-426 | ORAL | 25 mg in 1 1 | 12/13/2022 | |
Contract Pharmacy Services-PA | 67046-531 | ORAL | 20 mg in 1 1 | 7/31/2010 | |
Solco Healthcare LLC | 43547-409 | ORAL | 7.5 mg in 1 1 | 8/15/2017 | |
Apotex Corp | 60505-4378 | ORAL | 25 mg in 1 1 | 1/10/2024 | |
Rhodes Pharmaceuticals L.P. | 42858-707 | ORAL | 37.5 mg in 1 1 | 9/30/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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