FDA Approves New Antidepressant Levomilnacipran

FDA Approves New Antidepressant Levomilnacipran

Levomilnacipran AntidepressantLevomilnacipran, CAS number 96847-55-1, has been a headline in the recent pharmaceutical news. This headline status is due to the FDA approval of Fetzima, the brand name for Levomilnacipran, at the end of July 2013. Approved as a medication to treat major depressive disorder in adults, Levomilnacipran is designed as a once daily dose. As an SNRI, or serotonin and norepinephrine reuptake inhibitor, Levomilnacipran is marketed as Fetzima by Forest Laboratories, which has plans to have this antidepressant available by the fourth quarter of 2013.

Serotonin–norepinephrine reuptake inhibitors SNRIsResults from several Phase lll studies of Levomilnacipran revealed marked success for this SNRI antidepressant. Three studies in particular were highlighted, leading to the approval of this drug by the FDA. The three Phase lll studies included two studies which were fixed dose, and one study which was flexible dose. All three studies included over 1,600 adult participants, in double-blind and placebo controlled settings. In all three studies the use of Levomilnacipran by patients led to statistically greater improvements in depressive symptoms  as compared to the patients who were given a placebo. The dosages of Levomilnacipran were either 40 milligrams, 80 milligrams or 120 milligrams, one time daily. With the exception of the flexible dosing group, all of the participants were given consistent daily doses. The adverse effects were few, and mainly consisted of complaints of nausea amongst patients who received all of the dose strengths.

FDA Approved July 2013 Levomilnacipran 96847-55-1The once a day dosage of Levomilnacipran is ideal for patients as this method of dosing provides a sustained release action. Additionally, the ease of a one-time daily dose makes it less of an issue for patients to remember to take their medication multiple times throughout the day, leading to better medication adherence. With The World Health Organization predicting that depression will be the second leading cause of disability by the year 2020, the advent of a new antidepressant like Levomilnacipran is much needed. The approval of Levomilnacipran will be helpful not only to future patients suffering from depression worldwide, but it is also crucial for the 15 million Americans who are suffering from depression currently.

LGM Pharma provides Levomilnacipran for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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