The FDA has granted approval to Fabre-Kramer Pharmaceuticals' Exxua for the treatment of major depressive disorder (MDD) in adults. This marks an important milestone in the field of depression treatment as Exxua is the first antidepressant to specifically target the serotonin 1A receptor, which plays a crucial role in mood and emotion regulation.
Dr. Stephen Stahl, a renowned psychiatrist, highlighted the significance of Exxua's approval, stating, "EXXUA is the first truly selective agonist of the serotonin 1a receptor that has been consistently linked to mediation of mood disorders and suicide risk." He further emphasized the drug's importance as an addition to the existing arsenal of depression treatments.
Fabre-Kramer Pharmaceuticals describes Exxua as a groundbreaking antidepressant that has demonstrated efficacy in alleviating depressive symptoms. Unlike other antidepressants, Exxua's approved label does not include warnings or adverse reactions related to sexual dysfunction or weight gain compared to a placebo. This aspect sets Exxua apart from its counterparts and may offer a favorable option for individuals struggling with MDD.
The medication is expected to be available in pharmacies by early 2024, providing patients and prescribers with a new treatment option for managing depression and improving quality of life. Stephen Kramer, M.D., CEO of Fabre-Kramer, expressed the importance of offering a wide range of effective treatment options, stating, "There is value in providing prescribers and patients with a wide range of effective options for use in clinical practice. We are proud to bring this innovative therapy to patients who need a new option to manage their depression and improve their quality of life."
Exxua, which has been studied in over 5,000 patients, works in a unique manner by targeting a specific receptor in the brain to relieve depressive symptoms. The drug has shown minimal side effects, with any sexual side effects reported in clinical trials being similar to those experienced by individuals taking a placebo. These side effects were not serious enough to warrant a warning on the label. Exxua also has a generally safe profile, not causing significant issues with weight, blood pressure, heart rate, or liver function. The most common side effects observed in clinical trials were mild dizziness and nausea, typically associated with dose increases but did not result in treatment discontinuation.
While the exact mechanism of Exxua's antidepressant effect is not fully understood, it is believed to be associated with its ability to regulate serotonin activity in the central nervous system. This is achieved through the drug's selective agonistic action on 5HT1a receptors. Both Exxua and its active metabolite demonstrate strong and specific binding to these receptors, contributing to its therapeutic efficacy.
With the FDA approval of Exxua, individuals with major depressive disorder now have a new treatment option that targets a specific receptor in the brain, offering the potential for improved management of their condition and an enhanced quality of life.
