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DAR No 3: Desvenlafaxine. Pristiq® in mayor depressive disorder in adults

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  • Desvenlafaxine is an active metabolite of venlafaxine.
  • In three placebo-controlled trials, the results on the reduction in HAM-D17 score were not consistent.
  • The most common adverse effects are of gastrointestinal origin or sleep disorders. There are no available long-term safety data.
  • In the only head-to-head trial carried out in post-menopause women, desvenlafaxine at high doses did not show superiority versus escitalopram.
  • The pharmaceutical company withdrew the application for marketing authorisation after an initial evaluation by the EMA´s CHMP that concluded that desvenlafaxine was less effective than venlafaxine and did not present any advantages with regard to safety.

 

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