FDA approves Spravato – ketamine related drug for treatment-resistant depression

FDA approves Spravato – ketamine related drug for treatment-resistant depression

June 13, 2019

FDA approves Spravato – ketamine related drug for treatment-resistant depression

Depression Mental Health

The Food and Drug Administration (FDA) has recently approved Spravato, a nasal spray manufactured by Johnson & Johnson (J&J), as a fast-acting treatment for patients suffering from treatment-resistant depression. This chemical cousin of ketamine is the first of its kind to be reconsidered as a means of treating patients who have failed to achieve relief with the use of at least two other depression medications.

Ketamine is known as an underground rave party drug famous for producing hallucinogenic effects. Of late, in an attempt to help people battling treatment-resistant depression, a few doctors have experimented by administering ketamine to depression patients without any approval from the FDA. Around 7.4 million Americans suffer from treatment-resistant depression increasing their risk of hospitalization, suicide, and other mental and physical harm.

Based on several factors such as insurance rebates, discounts, and the dosage, Spravato is expected to be priced between $590 and $885. Ever since the launch of Prozac and other such antidepressants during the 1980s, there have been no major pharmaceutical breakthroughs for depression. Further, these drugs used to take weeks or months to start showing their effects.

Ketamine and Spravato work differently

The FDA approved drug, Spravato works differently than ketamine. The former targets glutamate, a chemical that helps restore brain connections and relieve depression. The effect of the drug is immediate, which is a boon, especially since physicians can quickly change to other drugs said Dr. John Mann, researcher and psychiatrist at the Columbia University.

Also known as esketamine (chemically), the nasal spray proved to improve depression levels in patients using this drug as compared to patients administered a placebo. The results of the study were measured using a psychiatric questionnaire. Spravato is relatively easier to use than ketamine and the dose is also much lower. Ketamine is usually administered to depression patients as an intravenous infusion.

FDA’s approval of esketamine may smoothen the road ahead for other drugs

Esketamine is the first of numerous psychoactive substances that cleared the U.S. regulatory process, at a time when physicians were still looking for new therapies to treat depression. Presently, psilocybin and MDMA are going through the last stages of clinical trials as potential treatments for post-traumatic stress disorder (PSTD) and depression. Psilocybin is the active ingredient found in magic mushrooms and MDMA is a category of club drug known for its euphoria-producing properties.

However, unlike ketamine, the aforementioned drugs are generally not considered to be used for medical purposes, as they fall under the banned categories of LSD and heroin. However, considering the approval of esketamine by the FDA, the path for these other drugs for future consideration may become somewhat easier.

Spravato will be subjected to restrictions

Keeping in mind the side effects, abuse potential, and the safety questions surrounding the use of Spravato, the drug will be subjected to certain legal restrictions. For instance, it can only be prescribed by qualified practitioners who must keep patients under observation for two hours after administering the drug. This is done owing to the disorienting effects caused by the drug. Apart from this, all the patients administered this drug will be tracked to observe its effectiveness and long-term safety.

While the effect of ketamine lasts for just four to seven days, there is no common agreement on how long the patients can benefit from this treatment. Keeping high expectations from Spravato, the Wall Street analysists have predicted more than $600 million annual sales of the drug by 2020.

Some physicians are planning to offer a combination of ketamine and Spravato. According to Dr. Steve Levine, with its high FDA standards in terms of administration and dosage, Spravato will be raising the level of standards in the field of depression treatment drugs. He believes that it will drive out other physicians not qualified to treat depression. Also, considering the regulation and standards associated with this new drug, Dr. Levine believes that it will be relatively safer and more accessible to patients suffering from depression.

Seeking treatment for depression

Depression is an incapacitating disorder. If left untreated, it can severely lower an individual’s quality of life and can also lead to suicide ideation. Therefore, it is imperative that one seeks professional help, either themselves or help loved ones to do so, as soon as one observes its symptoms or is diagnosed with depression.

If you or a loved one is battling depression, feel free to reach out to the Invictus Health Group. We can connect you with reliable inpatient treatment centers for depression. Call our mental health treatment helpline 866-548-0190 for more information about inpatient programs for depression. You can also chat online with a representative for further information.

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