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Pristiq (desvenlafaxine)
Pristiq (generic name: desvenlafaxine) is a Serotonin and Norepinephrine Reuptake Inhibitor drug developed by Alembic Pharms Ltd. It is currently FDA-approved (first approved 2008) for Major depressive disorder.
Pristiq works by blocking the reabsorption of serotonin and norepinephrine in the brain, allowing more of these neurotransmitters to be available for use.
Pristiq (desvenlafaxine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) developed by Wyeth Pharms Inc and currently owned by Alembic Pharms Ltd. It targets the sodium-dependent serotonin transporter and is used to treat major depressive disorder. Pristiq is a small molecule with an 8.4-hour half-life and is off-patent, allowing for generic competition. As an SNRI, it works by increasing the levels of serotonin and norepinephrine in the brain, which helps to improve mood and reduce symptoms of depression. Pristiq was FDA-approved in 2008 and is available in the market.
At a glance
| Generic name | desvenlafaxine |
|---|---|
| Sponsor | Alembic Pharms Ltd |
| Drug class | Serotonin and Norepinephrine Reuptake Inhibitor |
| Target | Sodium-dependent serotonin transporter |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2008 |
| Annual revenue | 1041 |
Mechanism of action
The exact mechanism of the antidepressant action of desvenlafaxine is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake. Non-clinical studies have shown that desvenlafaxine succinate is potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI).
Approved indications
- Major depressive disorder
Boxed warnings
- WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] . PRISTIQ is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants ( 5.1 ). • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). • PRISTIQ is not approved for use in pediatric patients ( 8.4 ).
Common side effects
- Nausea
- Dry mouth
- Constipation
- Vomiting
- Dizziness
- Somnolence
- Hyperhidrosis
- Anxiety
- Insomnia
- Tremor
- Fatigue
- Decreased appetite
Drug interactions
- eletriptan
- frovatriptan
- isocarboxazid
- naratriptan
- pargyline
- phenelzine
- procarbazine
- rasagiline
- rizatriptan
- selegiline
- sumatriptan
- tapentadol
Key clinical trials
- A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
- Desvenlafaxine for Preventive Treatment of Frequent Migraines (NA)
- The Analgesic Efficacy and Safety of Desvenlafaxine in Patients With Herpes Zoster (NA)
- Desvenlafaxine for Preventive Treatment of Frequent Episodic Tension-type Headache (NA)
- The Efficacy and Safety of Pregabalin Combined With Desvenlafaxine in Patients With Fibromyalgia (NA)
- Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression (PHASE2)
- Predictors of Cognitive Outcomes in Geriatric Depression (PHASE4)
- Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pristiq CI brief — competitive landscape report
- Pristiq updates RSS · CI watch RSS
- Alembic Pharms Ltd portfolio CI
Frequently asked questions about Pristiq
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Related
- Drug class: All Serotonin and Norepinephrine Reuptake Inhibitor drugs
- Target: All drugs targeting Sodium-dependent serotonin transporter
- Manufacturer: Alembic Pharms Ltd — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Major depressive disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing