Exxua for the Treatment of Major Depressive Disorder

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Clinical depression, also known by its scientific name “Major Depressive Disorder, is a highly debilitating mental condition characterized by persistent feelings of sadness as well as loss of interest or pleasure.

This condition can also have a serious impact on daily functioning, and it affects millions of people around the world, regardless of age, race, or socioeconomic status.

Technically speaking, there’s a variety of antidepressant medications out there that can help with this condition, especially Selective Serotonin Reuptake Inhibitors or SSRIs (the most prescribed drug).

That being said, these drugs often have serious adverse reactions and effects on their users, ranging from weight gain and insomnia to noticeable sexual dysfunction.

Additionally, some individuals experience a delayed response or incomplete symptom relief with SSRIs. The good news is that there’s a new and highly promising drug on the market that can tackle all these issues, called Exxua.

In this article, we’ll take a closer look at this drug, how it works, and what makes it a great alternative to classic MDD medications.

A Brief Overview of Exxua

Exxua is one of the newest treatments indicated for the treatment of major depressive disorders, especially in adults.

The drug was developed by Fabre-Kramer Pharmaceuticals Inc. and earned its FDA approval in late 2023.

One thing you should here is that Exxua is the brand name of a new chemical known as “gepirone hydrochloride”, which is considered a serotonin receptor agonist.

The treatment is currently available in the form of extended-release tablets and functions fairly differently when compared to traditional antidepressants.

Exxua’s Mechanism of Action

Gepirone’s unprecedented approach to treating clinical depression lies in its mechanism of action and its effect on serotonin.

Serotonin is a crucial neurotransmitter involved in regulating mood, sleep, appetite, and various other physiological processes. In individuals with MDD, serotonin activity is often heavily reduced, leading to depression symptoms.

Most drugs on the market focus on increasing serotonin levels by blocking the reuptake mediators. However, these drugs are not selective, which results in affecting other processes of the body, leading to various side effects.

What’s different about Exxua is that it’s a highly selective partial agonist of the 5HT1A receptor alone. This allows the drug to increase the specific variety of serotonin responsible for targeting depression without disrupting the balance of other chemicals necessary for other functions.

While gepirone exerts most of its effect on 5HT1A receptors, it can also reduce the activity of 5HT2A receptors by acting as an antagonist.

Some studies suggest that high activity of this receptor is also linked with various mental health disorders, such as schizophrenia, bipolar disorder, substance abuse, and specific forms of depression.

Clinical Development and Approval of Exxua

The development of Exxua involved a series of clinical trials, which were designed to assess its efficacy and safety for treating MDD.

These trials typically involved adult participants diagnosed with MDD who were randomly assigned to receive either Exxua or a placebo (an inactive substance).

Researchers then monitored the participants for a set period, measuring their depressive symptoms using standardized scales.

After showing significant promise during these long-lasting trials, the drug went into the US Food and Drug Administration (FDA) approval phase.

While the drug has been recently approved, its initial research actually dates back to the 1990s and went through rigorous efficacy standards to earn approval.

Exxua’s Dosage and Administration

Exxua comes as an extended-release tablet formulation, designed for once-daily administration. This dosage form makes it much easier to adhere to the drug’s dose, especially when compared to other antidepressants that require multiple daily doses.

The current baseline dose of the drug is 18.2 milligrams taken once daily. However, depending on the individual’s response and tolerability of the drug, a healthcare provider may adjust the dosage over time, with a maximum daily concentration of up to 72.6 mg once daily.

According to the drug’s instructions, the drug should be taken with food at around the same time each day to ensure a consistent absorption and concentration of the drug in the bloodstream.

It’s also worth noting that using the drug and any dose adjustments must be done under the supervision of a qualified healthcare professional, as self-medication and changing the dosage can massively affect the drug’s effectiveness.

How Effective is Exxua in the Treatment of Major Depressive Disorder?

As previously established, Exxua demonstrated statistically significant improvement in depressive symptoms compared to a placebo in clinical trials. Additionally, the drug’s massive effectiveness also showed a promising edge when compared to other antidepressants.

However, since the drug is relatively new, further data are still necessary to establish the drug’s effectiveness against other antidepressants. This is mainly because the individual response to various antidepressants can massively vary from one person to another.

Other factors like co-existing mental health conditions and severity of depression can also impact the drug’s effectiveness, especially since the drug works by gradually normalizing serotonin signaling, instead of simply increasing its levels.

What Does Exxua Bring to the Table?

The unique pharmacology of Exxua doesn’t only enhance its effectiveness during the treatment of MDD, but it also provides several advantages regarding its associated adverse events. Here’s a quick look at some of them:

High Selectivity

Unlike other clinical depression medications, Exxua acts with a remarkably high selectivity, targeting only the 5HT serotonin 1A receptor.

This highly targeted mechanism of action minimizes the drug’s side effects without compromising its potency.

Little to No Sexual Side Effects

One of the main problems other SSRIs suffer from is the high prevalence of sexual side effects, which lasts for a long time even after discontinuing the drug. However, the selectivity of Exxua reduces the risk of these side effects significantly.

Doesn’t Cause Weight Gain

Another advantage of high selectivity is that Exxua helps in reducing depressive symptoms without causing weight gain like plenty of SSRIs and antianxiety medications out there.

Sustained Release

The extended-release tablet formulation of Exxua provides a convenient dosing routine with just one pill needed daily. Other SSRIs may require a dose of up to 3 times a day.

That being said, the drug’s dosage can still be increased up to every 8 hours if medical necessity calls so. However, this is a remarkably high dose that should only be taken under the doctor’s supervision.

Minimal Risk of Dependence and Abuse

Lastly and most importantly, many antidepressants and antianxiety medications are associated with a high risk of tolerance and dependence.

Meanwhile, no reports of heavy abuse associated with Exxua use have emerged, which shows its promise in treating MDD without creating new problems.

What Are the Side Effects of Exxua?

Like any other medication, Exxua can still cause side effects in some individuals. The good news is that the side effect profile of Exxua appears to be generally well-tolerated compared to some traditional antidepressants.

The most relatively common adverse effect of using Exxua is dizziness, especially in the initial stages. This could be accompanied by nausea in some patients, especially when taking the drug on an empty stomach.

Other less common side effects of the drug include headaches, insomnia, abdominal pain, and dyspepsia.

In addition to the drug’s side effects, it also bears the risk of interacting with several drugs. This includes various drugs that affect the rate of the enzyme CYP3A4. Similarly, patients who take monoamine oxidase inhibitors should avoid using Exxua.

Who Shouldn’t Use Exxua?

Exxua is contraindicated in individuals with a history of allergic reactions to gepirone or other ingredients in the medication.

Additionally, people with certain medical conditions, including long QT syndrome (a heart rate abnormality), should avoid taking the drug, as it increases the prolongation of QT interval.

It’s also worth noting that the drug is primarily tested on adult patients, so doctors will typically recommend against using it with pediatrics, children, and adolescents.

This also extends to pregnant and breastfeeding women, since there isn’t enough information about the drug’s safety during this time.

Can You Switch Your MDD Treatment to Exxua?

Switching from your current MDD medication to Exxua is possible but it requires your doctor’s permission, as you can’t simply drop one drug and use the other.

Depending on your current medication and its half-life, your doctor might recommend gradually tapering off your existing medication before starting Exxua.

This allows your body to gradually clear the older antidepressant from your system while introducing Exxua. It also minimizes the risk of potential interactions or side effects during the transition.

Keep in mind that Exxua’s half-life is also around 5 hours, and it might take up to 14 days before it’s completely eliminated from the body. This means that switching from Exxua to other antidepressants also requires careful planning and consideration.

Final Thoughts

This marks the end of today’s guide that walks you through everything you should know about Exxua, the latest treatment for major depressive disorder.

As you can see, the drug promises a wide range of advantages when compared to traditional SSRI treatments, but it’s not without its side effects and challenges.