Last reviewed · How we verify
DESVENLAFAXINE SUCCINATE
Desvenlafaxine succinate is a marketed drug primarily indicated for Major Depressive Disorder. Its key composition patent is set to expire in 2028, providing a period of market exclusivity. The primary risk is the potential increase in competition following patent expiry.
At a glance
| Generic name | DESVENLAFAXINE SUCCINATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2008 |
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
- Dizziness
- Insomnia
- Constipation
- Somnolence
- Fatigue
- Decreased appetite
- Vomiting
- Tremor
- Anxiety
- Abnormal dreams
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
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DESVENLAFAXINE SUCCINATE CI brief — competitive landscape report
- DESVENLAFAXINE SUCCINATE updates RSS · CI watch RSS