Ketamine Nasal Spray Close to FDA Approval

Ketamine has been going through an image transition. Originally created to be a medical anesthetic, it soon became popular as a party drug known, as Special K. It’s illicit street use gave it a bad rap, but in recent years doctors have been going off label using it to treat depression. Ketamine infusion therapy is now a popular alternative depression treatment and has shown promise for a number of other disorders such as suicidal behavior too.

 

As the number of positive case studies mounted, the FDA put two ketamine-based pharmaceuticals on the approval fast track. Johnson & Johnson has been working on a nasal spray form of esketamine (a specific type of ketamine) for the treatment of treatment-resistant depression. Called Spravato, the spray would make ketamine treatments more affordable and easier.

 

Last week the FDA recommended the approval of Spravato in a 14-2 vote. The committee determined the spray had a favorable benefit-risk profile. Research on the drug found that it greatly improved depression symptoms when used alongside a traditional antidepressant.

 

However, there are downsides. The drug, as with traditional ketamine infusion therapy, has sedative and dissociative side effects. Because of this the committee recommended the spray not be allowed to be self-administered by patients at home. This means patients would still need to go to the doctor. While this is a hurdle, Spravato will be safer, quicker, and cheaper than infusions. It’s expected that if the drug performs well the program may become more flexible.

 

Many are concerned about the risk of addiction, especially since ketamine is still a popular party drug. So far ketamine infusion therapy hasn’t resulted in increased addiction, however, it’s so new that there isn’t any long-term data. By administering it intranasal though, the drug bypasses the liver and other organs, allowing it to be effective in a lower dose, which reduces the risk of dependency.

 

Hopefully, the ketamine nasal spray will get full FDA approval soon and begins rolling out. We’ve seen tremendous success with our patients suffering from treatment-resistant depression with ketamine therapy options. Contact us to learn more about ketamine therapy and how it can help you.

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Dr. Rodriguez founded the Delray Center in 2003 and built it on a foundation of core clinical, professional, and ethical principles that are adhered to still to this day. Dr. Rodriguez founded the Delray Center in 2003 and built it on a foundation of core clinical, professional, and ethical principles that are adhered to still to this day.