Lundbeck has filed a new generation of antidepressant, vortioxetine, with the European Medicines Agency.
The Danish drugmaker says that vortioxetine, formerly known as Lu AA21004, has been developed for the treatment of patients with major depressive episodes. More than 5,000 individuals have been exposed to vortioxetine across the entire clinical trial programme and statistically significant results were established in major depression on all doses, from 5 to 20mg, Lundbeck states.
Vortioxetine is thought to work through a combination of two mechanisms of action: receptor activity modulation and reuptake inhibition. In vivo studies have demonstrated that the drug enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain.
Lundbeck R&D chief Anders Gersel Pedersen, said the firm is pleased to have filed vortioxetine in Europe "as many people suffering from major depression still struggle to find an effective treatment". He added that "we are currently working with our partner, Takeda, to file the application in the USA later in the year and in Japan next year." Lundbeck will submit vortioxetine to Health Canada during the second half of this year.
The company has high hopes for vortioxetine as it faces up to the loss of patent protection on its flagship antidepressant Cipralex (escitalopram), known as Lexapro in the USA where it is sold by Forest Laboratories.