Gepirone ER, marketed as Exxua, is a first-in-class therapy approved by the US Food and therapy Administration (FDA) to treat major depressive disorder (MDD).
This information was released last week by the drug's producer, Fabre-Kramer Pharmaceuticals.
According to Science Direct, the medicine is distinct in that it targets the brain's serotonin 1A receptor specifically. Serotonin is essential for mood regulation.
It does this by activating the 1A receptor, which not only releases dopamine — a neurotransmitter essential for conveying messages throughout the brain — but also controls serotonin.
Weight gain and sexual dysfunction are known side effects of other antidepressant drug kinds. Additionally, Fabre-Kramer emphasises that there are no ‘’warnings or adverse reactions’’ regarding weight gain or sexual dysfunction on the label, which has been approved.
Common side effects of other antidepressants include weight gain and sexual dysfunction, particularly with first-line generic serotonin selective re-uptake inhibitors (SSRIs).
One of Exxua's key differentiators and major potential benefits is the absence of these issues.
Furthermore, several antidepressant medications either don't interact with the serotonin 1A receptor or, when they do, they do so in combination with a variety of other receptors.
According to WebMD, the only drug that is currently licensed for treating depression that selectively activates the serotonin 1A receptor is Exxua.
Mild and transient nausea and dizziness were the most common side effects, according to the company, in a trial with 5,000 participants.
According to the business, pharmacies should carry Exxua by early 2024. Gepirone hydrochloride, the medication's scientific name, will be marketed as tablets.
Due to ineffective trials, the FDA had already rejected three applications for the medication. After several years of testing involving over 5,000 patients, the medication was approved by the FDA.
According to clinical research, the Exxua has an overall satisfactory safety profile. The most common side effects were mainly moderate and transient nausea and dizziness. The drug has a 24-hour period of extended and regulated release and is taken once daily.
Exxua is used to treat Major Depressive Disorder (MDD), which is defined by enduring feelings of sorrow and disinterest, according to the Mayo Clinic.
People with MDD may also struggle with a variety of physical and mental issues that make daily tasks challenging.
It differs from depression alone in that it is a collection of symptoms that include not just depression or melancholy but also an inability to feel pleasure or reward.
Changes in energy, hunger and focus may be present, along with trouble sleeping and, in certain situations, suicidal thoughts or actions.
Experts further state that, in their opinion, the drug's antidepressant action is not wholly original. He mentions buspirone, an anti-anxiety drug that functions by acting on the serotonin 1a receptor in a similar way.
According to specialists, the medication is a valuable addition to the toolkit for treating depression.
They also recommend that those who suffer from severe depression speak with a doctor to determine whether the medicine is appropriate for them.