Auvelity is a new drug developed by Axsome Therapeutics approved by the US Food and Drug Administration (FDA) to treat major depressive disorder in adults. This medication uses a new oral mechanism of action, the first of its kind approved for major depressive disorder in more than 60 years, and produces statistically significant improvement in depressive symptoms as early as one week.
Axsome, which is a biopharmaceutical company that develops novel therapies to treat central nervous system (CNS) disorders, has designed Auvelity – a twice-daily pill – to start working quickly because, in In most cases, the drugs used to treat depression take a long time to show effectiveness and have side effects, which are sometimes serious.
The mechanism of action of many antidepressants is to inhibit monoamine oxidase (MAO), blocking the ability of this enzyme to remove key neurotransmitters from the brain. Although it is very common to prescribe MAO inhibitor drugs, a large number of patients do not respond to them, and even in those who do, the effect can take six weeks or more to be seen.
An oral drug for depression with fast results
The two main components of Auvelity are old drugs, as the new product combines bupropion – which is the active ingredient in GSK’s old antidepressant and smoking cessation drug Wellbutrin – with dextromethorphan, which is an ingredient in many cough medicines. . Axsome has combined these active ingredients with proprietary technology that modulates the delivery of each compound.
Clinical trials with Auvelity have not shown psychotic symptoms or weight gain, which are common side effects of other drugs used to treat depression.
Dextromethorphan crosses the blood-brain barrier to target the part of the brain that causes coughing, and in Auvelity it is used to block the NMDA receptor, making it the first new oral drug for depression in more than 60 years that works by addressing a target that is not the MAO. The bupropion content of the drug increases dextromethorphan levels in the blood.
Axsome has reported that in the clinical trials that have been carried out to test the efficacy and safety of its drug, it met the main objective of showing a statistically significant decrease in symptoms of depression in the sixth week, measured according to the scale of qualification for depressive episodes, and that statistically significant results were observed in the first week, just four days after receiving the target dose.
Axsome CEO Herriot Tabuteau explained that patients with varying levels of prior experience with other treatments for depression were enrolled in clinical trials, and that medical professionals will be the ones to determine whether Auvelity should be prescribed as a first treatment, or as an alternative therapy. second or third line.
From the pharmaceutical company they have highlighted that in clinical tests no signs of psychotic symptoms or weight gain have been detected, which are common side effects of other drugs to treat depression. There is a black box warning on the drug’s label that an increase in suicidal thoughts and behaviors is a risk of antidepressants in children and young adults, but Tabuteau says this is a standard warning for antidepressants. depression and that Auvelity is not currently approved for children.
.