Overview
Doxepin is a psychotropic agent with antidepressant and anxiolytic properties. It is a tertiary amine that can be presented as (E) and (Z) stereoisomers with the (Z) stereoisomer corresponding to cidoxepin. Doxepin commonly produces a 5:1 (E):(Z) racemic mixture. In a strict sense, doxepin is not a tricyclic antidepressant but it is commonly associated with the class since it shares a lot of properties with members of the drug family including amitriptyline, clomipramine, desipramine, imipramine, nortriptyline, protriptyline and trimipramine. Doxepin was developed by Pfizer and FDA approved in 1969 as an antidepressant. However, in 2010 it was approved for the treatment of insomnia. The latter indication was presented by Pernix Therapeutics.
Background
Doxepin is a psychotropic agent with antidepressant and anxiolytic properties. It is a tertiary amine that can be presented as (E) and (Z) stereoisomers with the (Z) stereoisomer corresponding to cidoxepin. Doxepin commonly produces a 5:1 (E):(Z) racemic mixture. In a strict sense, doxepin is not a tricyclic antidepressant but it is commonly associated with the class since it shares a lot of properties with members of the drug family including amitriptyline, clomipramine, desipramine, imipramine, nortriptyline, protriptyline and trimipramine. Doxepin was developed by Pfizer and FDA approved in 1969 as an antidepressant. However, in 2010 it was approved for the treatment of insomnia. The latter indication was presented by Pernix Therapeutics.
Indication
Oral doxepin is approved for the following indications: Topical doxepin is also approved for short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis, pruritus or lichen simplex chronicus. Off-label, doxepin is used topically for the management of neuropathic pain. Depression is a common medical illness that causes feelings of sadness and or loss of interest in prior enjoyable activities. This condition can lead to emotional and physical disturbances that can decrease the ability of a person to function in a regular environment. Anxiety is a normal reaction of the body towards a normal danger. When the anxious state is exacerbated or appears on situations without danger, it is defined as an anxiety disorder. This disorders can appear in different forms such as phobias, panic, obsessive-compulsive disorder and post-traumatic stress disorder. Insomnia is a sleep disorder that directly affects the quality of life of the individual. It is characterized by the complication either to fall asleep or to stay asleep. This condition can be occasional or chronic. Pruritus is defined as an unpleasant skin reaction that provokes the urge to scratch. It can be localized or generalized and it can appear in an acute or chronic manner. Neuropathic pain occurs due to the damage or dysfunction of the peripheral or central nervous system rather than stimulation of the pain receptors.
Associated Conditions
- Anxiety
- Bipolar Disorder (BD)
- Depression
- Depression, Involutional
- Insomnia
- Lichen simplex chronicus
- Neuropathic Pain
- Neurotic depression
- Pruritus
- Psychotic depressive disorder
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/08/30 | Not Applicable | Recruiting | |||
2021/11/10 | Phase 3 | UNKNOWN | State University of New York - Upstate Medical University | ||
2021/11/04 | Not Applicable | UNKNOWN | |||
2020/10/19 | Not Applicable | Completed | Aalborg University | ||
2020/09/18 | Not Applicable | Completed | Aalborg University | ||
2019/05/09 | Not Applicable | Withdrawn | Aalborg University | ||
2018/11/29 | Phase 4 | Completed | |||
2016/09/08 | N/A | Terminated | |||
2015/05/18 | Phase 2 | UNKNOWN | |||
2015/03/02 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-700 | ORAL | 10 mg in 1 1 | 12/13/2021 | |
Par Pharmaceutical, Inc. | 49884-220 | ORAL | 75 mg in 1 1 | 10/5/2022 | |
NORTHSTAR RX LLC | 16714-133 | ORAL | 25 mg in 1 1 | 10/21/2020 | |
Contract Pharmacal Corp. | 10267-5059 | ORAL | 10 mg in 1 1 | 8/6/2020 | |
Edenbridge Pharmaceuticals LLC. | 42799-935 | ORAL | 150 mg in 1 1 | 5/26/2022 | |
Ajanta Pharma USA Inc. | 27241-168 | ORAL | 25 mg in 1 1 | 11/24/2021 | |
REMEDYREPACK INC. | 70518-3494 | ORAL | 75 mg in 1 1 | 1/12/2024 | |
DIRECT RX | 61919-081 | ORAL | 50 mg in 1 1 | 8/5/2015 | |
Novadoz Pharmaceuticals LLC | 72205-092 | ORAL | 100 mg in 1 1 | 1/2/2020 | |
Florida Pharmaceutical Products, LLC | 71921-162 | ORAL | 10 mg in 1 1 | 9/24/2021 |
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 |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Doxepin Hydrochloride Tablets | 国药准字H14020311 | 化学药品 | 片剂 | 8/13/2020 | |
Doxepin Hydrochloride Tablets | 国药准字H37020217 | 化学药品 | 片剂 | 4/17/2020 | |
Doxepin Hydrochloride Tablets | 国药准字H32022317 | 化学药品 | 片剂 | 7/28/2020 | |
Doxepin Hydrochloride Tablets | 国药准字H32023097 | 化学药品 | 片剂 | 7/14/2020 | |
Doxepin Hydrochloride Tablets | 国药准字H32025206 | 化学药品 | 片剂 | 7/14/2020 | |
Doxepin Hydrochloride Tablets | 国药准字H31021425 | 化学药品 | 片剂(糖衣) | 12/27/2019 | |
Doxepin Hydrochloride Tablets | 国药准字H11020850 | 化学药品 | 片剂 | 6/1/2020 | |
Doxepin Hydrochloride Tablets | 国药准字H64020138 | 化学药品 | 片剂 | 12/18/2019 | |
Doxepin Hydrochloride Tablets | 国药准字H31020447 | 化学药品 | 片剂 | 5/28/2024 | |
Doxepin Hydrochloride Tablets | 国药准字H32022163 | 化学药品 | 片剂 | 7/30/2020 |
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 |
---|---|---|---|---|---|
DEPTRAN 25 doxepin 25mg (as hydrochloride) capsule blister pack | 60448 | Medicine | A | 7/2/1997 | |
DEPTRAN 10 doxepin 10mg (as hydrochloride) capsule blister pack | 308999 | Medicine | A | 12/17/2018 | |
Deptran 50 hexagonal tablet blister pack | 17637 | Medicine | A | 9/20/1991 | |
DEPTRAN 75 tablet blister pack | 42359 | Medicine | A | 10/19/1992 |