Content Creator and Designer
Published In: Mental Health | Oct 13 2023
Related Resources
In our quest to understand the intricacies of human psychology and mental health, we are continually transforming the landscape of treatment possibilities. One of the latest revolutions in this regard has been the groundbreaking FDA approval of the rapid acting oral antidepressant drug Auvelity, manufactured by Axsome, to treat Major Depressive Disorder (MDD).
According to recent statistics, in 2021, about 21 million American adults had experienced at least one major depressive episode, making depression the leading cause of disability worldwide. The current approach to treating depression with oral antidepressants has been in place for the past 60 years, but there is a need for new and improved treatments that can achieve higher remission rates, have a faster onset of action, and are better tolerated.
However, traditional antidepressants like selective serotonin reuptake inhibitors, commonly take weeks to months to achieve their full effect, and many patients still experience residual symptoms. Moreover, remission rates are low, and current antidepressants come with side effects that include sexual dysfunction, sleep disturbances, weight gain, nausea, vomiting, diarrhea, and cognitive impairment.
A recent study called the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, funded by the National Institute of Mental Health, revealed some unfortunate insights into depression treatment. The study found that over 12.6 million American adults have received treatment for depression in the past year.
Shockingly, nearly two-thirds of diagnosed and treated patients failed to achieve remission with first-line therapy. The majority of those who failed to respond to the initial treatment also failed to respond to the second-line treatment. To be precise, 63.2% of adults experienced failure with first-line therapy in the landmark STAR*D study, while 69.4% of adults experienced failure with second-line therapy.
Launched by Axsome Therapeutics, one of Amazon’s leading innovative clinical-stage biopharmaceutical companies, Auvelity carries the designation of being the first — and currently, the only — oral N-methyl D-aspartate (NMDA) receptor antagonist approved for Major Depressive Disorder. It combines the action mechanisms of several different antidepressant therapies, making it unique in its approach to managing depression.
The dual active ingredients dextromethorphan and bupropion work synergistically, enhancing the neurotransmitter availability in the brain. This offers a statistically significant antidepressant efficacy and means that Auvelity acts fast, equipping healthcare providers with an effective tool to rapidly manage depressive episodes. This added speed provides immediate relief for those grappling with acute depressive episodes, marking a considerable advancement in the current treatment methods for MDD.
The Food and Drug Administration (FDA) approval of Auvelity in August 2022 corroborates the drug’s efficacy, opening new doors for millions of people struggling with depression. After robust clinical trials and rigorous scrutiny, Auvelity has proven to be effective in treating Major Depressive Disorder, a specific type of depression.
Its approval represents a paradigm shift in depression treatment, introducing a new class of oral rapid-acting antidepressants into the market. Considering the high prevalence of MDD worldwide, this new drug can well be a game-changer for the global health outlook.
In December 2022, Axsome Therapeutics announced further results from a trial called the EVOLVE (Evaluation of NMDA Modulation for Depressive Episodes) open-label trial. The EVOLVE trial was conducted in the United States and involved 146 patients suffering from MDD who had previously received one or more antidepressant treatments.
The treatment trial period involved administering Auvelity twice daily for up to 15 months, with the primary outcome measure of the study being to evaluate the change in the Montgomery-Asberg Depression Rating Scale total score from baseline to Week 6. The Cognitive and Physical Functioning Questionnaire (CPFQ), a patient-reported scale developed by Massachusetts General Hospital, was used to assess changes in cognitive and physical functioning in mood and anxiety disorders.
The new data was presented at the American College of Neuropsychopharmacology 2022 Annual Meeting in Phoenix, Arizona. Impressive results showed that the rapid antidepressant efficacy demonstrated by Auvelity produced swift and substantial improvements in depression symptoms as well as improvements in cognitive and physical functioning in patients with MDD. Treatment with Auvelity also proved to decrease disability in patients who had previously interacted with one or more antidepressants.
As cognition is frequently impaired during depressive episodes—disrupting attention, memory, and executive functioning—an antidepressant that can rectify these deficits can significantly enhance a patient’s quality of life. Auvelity has turned the tide by also demonstrating the ability to improve physical functioning, meaning patients may experience increased energy, improved sleep, and normalization of appetite patterns.
Auvelity emerges as a multifaceted medication and has positioned itself as a promising tool in the ongoing struggle against depressive disorders. For individuals suffering from treatment-resistant depression — who haven’t seen success with traditional forms of antidepressants — Auvelity can be the beacon of hope. With its novel approach and swift action, this new medication promises another shot at recovery for those patients who seem to run out of options.
As we strive to better understand mental health conditions and constantly improve the ways we deal with them, treatments like Auvelity are proof that we’re heading in the right direction. While it’s important to be optimistic about such advancements, it’s equally critical to remember that Auvelity, like any other medication, should always be taken under the supervision of a healthcare provider. Understanding how it works, its benefits, and potential side effects can help individuals make well-informed decisions regarding their health. If you need help with finding the right medications give us a call and speak to one of our qualified mental health professionals.
