US FDA approves LaboPharm's anti-depressant Oleptro
This article was originally published in Scrip
The US FDA has approved LaboPharm's once daily formulation of the antidepressant trazodone, known as Oleptro, for the treatment of major depressive disorder in adults, clearing the path for it to be launched later this year.
The company is actively seeing a commercialisation partner for Oleptro, which it says, could range from out-licensing the product to a full co-promotion arrangement under which it would share the drugs sales function with the partner.
Labopharm licensed the product from Angelini, which originally developed the immediate-release formulation that has been available for depression since the early 1970s and is taken two or three times daily. Angelini retains rights to the product in most of Europe, Japan and India.
Labopharm submitted the NDA for its new formulation of trazodone in September 2008. It is based on a single pivotal Phase III placebo-controlled clinical trial (study 04ACL3-001) that enrolled 412 adult patients and met its primary endpoint of change in the 17-item Hamilton depression rating scale (HAMD-17) after eight weeks (scripnews.com, February 20th, 2008).
The filing was subject to a complete response letter in July, in which the FDA cited deficiencies of the active pharmaceutical ingredient manufacturing facility (scripnews.com, July 21st, 2009).
Trazodone inhibits the reuptake of serotonin, but possesses a lower affinity for the serotonin transporter than the SSRI antidepressants. The drug's antidepressant and anxiolytic properties are also caused by its antagonist effects at the serotonin 5HT2a and 5HT2c receptors.
Additionally, the drug has sedative-hypnotic effects, which may stem from its strong antagonistic activity at the 5HT2a and alpha-1 adrenergic receptors. The firm claims that other antidepressants can be associated with exacerbations of sleep disturbances, and that once-daily trazodone could address this problem.