If
desvenlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI), is approved by the Food and Drug Administration, "it will be the first nonhormonal drug approved for treating hot flashes and nighttime awakenings," Dr.
SNRIs (eg, venlafaxine,
desvenlafaxine, duloxetine, and milnacip ran) can be effective and often are better tolerated than TCAs.
Desvenlafaxine at a dose of 100 mg daily recently has been reported to be effective for the treatment of hot flashes.
Pfizer (NYSE: PFE), a United States-based pharmaceutical company, has met its primary endpoint of change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score at week eight, for the Phase 4 major depressive disorder study of Pristiq (
desvenlafaxine) extended release tablets.
Currently Wyeth is seeking Food and Drug Administration approval for
desvenlafaxine to be branded as Prestiq.
Patients were randomized to daily
desvenlafaxine dosages of 50, 100, 150, or 200 rag, or placebo, and were scheduled to receive 52 weeks of treatment.
Venlafaxine has a half-life of 3 to 7 hours, and its active metabolite,
desvenlafaxine, possesses a half-life of 9 to 13 hours.
For moderate to severe bothersome hot flashes, potentially effective drug therapies used off label include clonidine, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), and gabapentin (TABLE 1), (2,4) In large, randomized, controlled trials, the following agents were modestly more effective than placebo:
desvenlafaxine, (5) low-dose paroxetine salt, (6) escitalopram, (7) and gastroretentive gabapentin.
The company has been sued for filing of an Abbreviated New Drug Application with the United States Food and Drug Adminstration with the FDA for
Desvenlafaxine Succinate Extended-release Tablets, 50 mg and 100 mg.
Potential high-profile products include paliperidone for schizophrenia,
desvenlafaxine for depression and vildagliptin for diabetes.
He was tapered off escitalopram and started on
desvenlafaxine, 50 mg/d; donepezil was increased to 10 mg/d.