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It’s called Auvelity and it’s the first antidepressant pill fast-acting approved by the Food and drug administration (Fda), which expressed its opinion on the matter on 19 August. He announces it in one Note Axosome Therapeutics, the US manufacturer of the drug: consisting of two different active ingredients, bupropion and dextromethorphan, Auvelity, for the first time in over 60 years, would have a different mechanism from the antidepressant therapies used so far, promising to treat the major depression in adults in less timewith a prolonged effect and with less side effects.
What is major depression and how is it treated?
Major depressive disorder (or major depression) is a debilitating and chronic disorder characterized by low mood, inability to experience pleasure, low energy levels, and other emotional and physical symptoms that are capable of compromising the mental and physical health of those affected, as well as fundamental aspects of life such as sociality, work, education; in severe cases, depression can lead to suicide. According to the data of the Higher Institute of Health (Iss), in Italy about 6% of the adult population reports having depressive symptoms and according to the World Health Organization (WHO), the Depression is the leading cause of disability worldwidecontributing significantly to the global burden of diseases.
For the treatment of major depression among the active ingredients currently available there are the so-called selective serotonin reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors: these drugs work, in fact, by hindering the action of receptors that, inside the brain, have the purpose of removing the serotonin released by the cells of the nervous system, neurotransmitter responsible, among other things, for the pleasure circuits and the mood. However, this type of medication shows only antidepressant effects after several weeks of treatment and, in many cases, the dosage must be optimized or multiple drugs must be combined to obtain the maximum therapeutic benefit. Not only that: almost two-thirds of patients with depression treated with currently available medicines report that not experiencing adequate beneficial effects, making the search for new therapies.
Advantages and disadvantages of the new drug
Auvelity, in fact, is the first oral medicine to be approved for the treatment of major depression which has a different mechanism of action from the active substances available so far. The molecules of which the drug is made act on a specific class of brain receptors (the so-called ionotropic glutamate receptors) which play a fundamental role in neuronal plasticity, and on another brain receptor called sigma-1. The exact molecular mechanism of Auvelity is unclearbut the clinical trials he was involved in to prove its safety and efficacy have shown that the drug is able to significantly reduce depressive symptoms compared to placebo, already during the first week of use, with long-lasting results. Furthermore, clinical studies have shown that treatment with the new drug was not associated withweight gainone of the unwanted side effects most reported by users of current antidepressants.
The manufacturing company hopes that the new drug will not only be able to offer faster and more prolonged antidepressant effects than other antidepressants approved so farbut also to present a concrete alternative solution for all those patients who benefit little from current treatment options, thus increasing the overall effectiveness of the drug compared to others. Yet there is no lack of reserves: as reported GlobalData HealthcareAxsome has not yet announced the price for this drug, but it will likely be a rather medicinal costly (GlobalData is priced at over a thousand dollars a year) compared to currently available antidepressants: the use of Auvelity as second-line drugif the available therapies do not work, they are much cheaper.
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