FDA to approve ketamine related drug for treatment-resistant depression in early March

A recent meeting of the advisory committee of the U.S. Food and Drug Administration (FDA) backed a new drug with ketamine like properties for the treatment of major depressive disorder (MDD). Known as esketamine, if approved by the FDA, the drug might be launched as a new option for patients suffering from treatment-resistant depression. Patients who have tried at least two other antidepressants without any positive outcomes would be eligible to use this new drug.

The drug, manufactured by the pharmaceutical company Janssen, a division of Johnson & Johnson, would be dispensed as a nasal spray. Approved by 14 out of the 17 experts on the advisory panel, the FDA is expected to sanction the drug in early March 2019. Though FDA does not need to follow the recommendations of the advisory committees to approve any drug, it often does pay heed to its decisions.

Ketamine-like properties

Esketamine closely resembles ketamine, a potent medication used in hospital settings as an anesthetic. Used for recreational purposes as Special K, a club drug, ketamine produces an extreme high and dissociative effects. However, emerging scientific data has demonstrated that it can be used for the management of treatment-resistant depression and suicide ideation.

Esketamine is not yet approved by the FDA. Compared to the traditional anti-depressants in use since many decades, esketamine targets a different brain pathway to treat depression. Although it is expected that this drug would be used in combination with the current antidepressants in use, the latter might take a month or two to exhibit their effect. On the contrary, esketamine starts showing effects within hours or days of its administration, stated the FDA briefing document.

Breakthrough therapy

In 2013, the FDA labelled esketamine as a breakthrough therapy intended to speed up the development and review of drugs to be used for grave or life-threatening ailments, like severe mental disorders. As per the briefing document, first line treatments fail to show positive outcomes for nearly 30 to 40 percent patients struggling with major depressive disorder.

However, there has been some criticism surrounding the research on esketamine because two out of the five major studies meant to back the FDA decision to approve it did not meet the primary endpoints. According to the briefing document, most-FDA approved antidepressants are backed by at least two major studies, however, in the case of esketamine, only one of the five studies returned a positive short-term trial result.

To be administered under professional supervision

The researchers observed that within two hours, administration of esketamine resulted in the manifestation of side effects such as a rise in blood pressure, dissociation, and sedation. Because of this reason, local pharmacies would not be allowed to stock and provide this drug to patients. It would only be administered under professional supervision so that the patient can be observed during those first two hours.

In addition, since the drug resembles ketamine, many experts have raised concerns about its potential to be abused and misused. However, during the meeting proceedings, the clinical trials claimed to have not encountered any evidence of this risk. Further, the advisory panelists also raised concerns about the dearth of long-term data establishing the cognitive effects of the drug and other health effects going forward.

During the esketamine trials, six patients died out of which three were suicide cases. However, FDA declared that it was difficult to associate these deaths directly to the drug.

Seeking treatment for depression

Depression is a debilitating disorder. If left untreated, it can severely lower one’s quality of life and can also cause suicide ideation. Therefore, it is imperative that one seeks profession help as soon as one receives a diagnosis of depression.

If you or a loved one are battling a depressive disorder and looking for depression treatment center, then get in touch with Medical Concierge of California. Depression may be a manifestation of something deeper – a trauma, substance abuse or any other reason. Our team of experienced therapists take into account these reasons and prepare an individualized depression treatment program that addresses all the underlying causes. For more information about our depression treatment programs, call our 24/7 helpline (877) 636-0042 or chat online to our representative.

0 replies

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply