Desvenlafaxine (brand name: Pristiq, Desfax, Ellefore), also known as O-desmethylvenlafaxine, is an antidepressant of the serotonin-norepinephrine reuptake inhibitor (SNRI) class developed and marketed by Wyeth (now part of Pfizer). Desvenlafaxine is a synthetic form of the major active metabolite of venlafaxine (sold under the brand names Effexor and Efexor). It is being targeted as the first non-hormonal based treatment for menopause.
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Medical uses
Desvenlafaxine's primary use in medicine is the treatment of major depressive disorder.
Adverse effects
Adverse effect incidence
Very common (>10% incidence) adverse effects include:
Common (1-10% incidence) adverse effects include:
Uncommon (0.1-1% incidence) adverse effects include:
Rare (<0.1% incidence) adverse effects include:
Unknown frequency adverse effects include:
Pharmacology
Desvenlafaxine is a synthetic form of the isolated major active metabolite of venlafaxine, and is categorized as a serotonin-norepinephrine reuptake inhibitor (SNRI). When most normal metabolizers take venlafaxine, approximately 70% of the dose is metabolized into desvenlafaxine, so the effects of the two drugs are expected to be very similar. It works by blocking the "reuptake" transporters for key neurotransmitters affecting mood, thereby leaving more active neurotransmitters in the synapse. The neurotransmitters affected are serotonin (5-hydroxytryptamine) and norepinephrine (noradrenaline). It is approximately 10 times more potent at inhibiting serotonin uptake than norepinephrine uptake.
Approval status
United States
Wyeth announced on 23 January 2007 that it received an "approvable" letter from the Food and Drug Administration for desvenlafaxine. Final approval to sell the drug was contingent on a number of things, including:
- A satisfactory FDA inspection of Wyeth's Guayama, Puerto Rico facility, where the drug is to be manufactured;
- Several postmarketing surveillance commitments, and follow-up studies on low-dose use, relapse, and use in children;
- Clarity by Wyeth around the company's product education plan for physicians and patients;
- Approval of desvenlafaxine's proprietary name, Pristiq.
The FDA approved the drug for antidepressant use in February 2008, and was to be available in US pharmacies in May 2008.
In March 2017, the generic form of the drug was made available in the US.
Canada
On February 4, 2009, Health Canada approved use of desvenlafaxine for treatment of depression. Pristiq is now available in Canadian pharmacies.
European Union
In 2008, Wyeth withdrew its application for Ellefore, the product under review for treatment of major depressive disorder in the European Union. In 2012, Pfizer received authorization in Spain to market Pristiq for the disorder in 50 mg and 100 mg tablets.
Australia
Desvenlafaxine is classified as a schedule 4 (prescription only) drug in Australia. It was listed on the PBS (Pharmaceutical Benefits Scheme) in 2008 for the treatment of MDD (Major Depressive Disorders).
Clinical efficacy
In clinical trials, desvenlafaxine demonstrated a significant superiority to placebo both in changes from baseline in the HAM-D17 score and in measures of well being such as the Sheehan Disability Scale (SDS) and 5-item World Health Organization Well-Being Index (WHO-5).
Source of the article : Wikipedia
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