The FDA has recently approved a new drug for the treatment of major depressive disorder in adults. Houston-based drug maker Fabre Kramer announced this breakthrough in a news release, stating that the drug is unique in that it does not exhibit the common side effects associated with other depression medications.
According to the company's news release, this drug is the first and only approved antidepressant that targets the serotonin 1A receptor, a key regulator of mood and emotion. In a trial involving 5,000 individuals, the most frequent side effects reported were mild and brief episodes of dizziness and nausea.
Fabre Kramer anticipates that the drug, named Exxua, will be available in pharmacies by early 2024. It will be sold in tablet form under the lab name gepirone hydrochloride.
It is worth noting that the FDA had previously rejected the drug's application three times due to unsuccessful studies. However, with the rising number of Americans experiencing major depressive disorder during the COVID-19 pandemic, there is a pressing need for new treatment options. Michael Pollock, CEO of the Depression and Bipolar Support Alliance, emphasized this urgency in the company news release, stating that approximately 30% of adults in the U.S. are now exhibiting more symptoms of depression.
Stephen Kramer, MD, CEO of Fabre-Kramer, hailed the approval of Exxua as a significant milestone in the treatment of major depressive disorder, a condition that affects millions of people worldwide.
In conclusion, the FDA has granted approval for a new antidepressant that shows promise in treating major depressive disorder. With its unique mechanism of action and reported lack of common side effects, Exxua offers hope for those living with this debilitating condition. As the drug becomes available in pharmacies next year, it may provide a new treatment option for individuals impacted by major depressive disorder.