FDA approves Exxua for depression treatment after multiple rejections over more than two decades 

The U.S. Food and Drug Administration (FDA) on Thursday approved Exxua, a treatment for major depressive disorder. This was an important step after decades of fighting for recognition.

Exxua is unique in its ability to target serotonin 1A receptors, which are regulators of mood and emotion. According to a press release from drug company Fabre-Kramer Pharmaceuticals, this will avoid unwanted side effects that are common with anxiety and depression medications, such as sexual dysfunction and weight gain.

Favre-Kramer said Exxua is the beginning of a “new class of antidepressants” that will be available in pharmacies in 2024.

“EXXUA marks an important milestone in the treatment of MDD, a serious and debilitating disease that affects millions of people worldwide,” Fabre-Kramer CEO Stephen Kramer said in a press release. Ta.

“There is value in providing prescribers and patients with a wide range of effective options that can be used in clinical practice. We need new options to manage depression and improve quality of life. “We are proud to offer this innovative treatment to our patients,” he continued.

The FDA had previously refused approval of the drug twice. reportedly As a result of several failed studies.

According to the drug company, recent studies were conducted on more than 5,000 patients and found that the drug had an “overall acceptable safety profile with no significant adverse effects on body weight, blood pressure, heart rate, or liver function.” is said to have been proven.

Dizziness and nausea were occasionally seen as side effects, but these were described as “mild, short-lived, associated with dose escalation, and did not require discontinuation of treatment.”

The company’s press release included several testimonials from prominent clinicians, researchers, and advocates praising the drug as a game-changer for patients.

Michael Pollock, CEO of the Depression and Bipolar Support Alliance (DBSA), linked the new drug to the nation’s mental health crisis.

“The mental health crisis in the United States is one of the most pressing health issues facing our country today. Prior to the COVID-19 pandemic, more than 20 million American adults suffered from major depressive disorder each year. These numbers have increased dramatically during the pandemic, with approximately 30% of U.S. adults, or more than 80 million Americans, experiencing developing symptoms of depression.” said.

“For people living with or affected by major depressive disorder, the need for new treatment options, especially those with new mechanisms of action, has never been clearer or more urgent. There won’t be any,” Pollack continued.