New Antidepressants Including Ketamine on FDA Fast Track
There have been a number of highly publicized suicides recently, including celebrity chef Anthony Bourdain and fashion designer Kate Spade. These have highlighted the need for newer and faster-acting antidepressants. Ketamine, which works quickly, is one drug that people are pushing for more frequently, despite the stigma it carries. Now it seems the Federal Drug Administrations (FDA) and pharmaceutical companies are listening, with several new antidepressants on the FDA fast track for approval.
Two major pharmaceutical companies are close to getting FDA approval on antidepressants that act similarly to ketamine. When using ketamine in small doses, it creates a dissociative feeling, relieving pain. And, appearing to help people with mental disorders such as depression, PTSD, and others. Ketamine has a bad reputation though. Its original use was as an anesthetic but it’s now a popular street drug due to its dissociative effect. This stigma has caused medical professionals to be wary of it, despite its effectiveness. Now medical professionals can’t afford to not look at this highly effective drug.
Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), announced they were finishing up a Phase 3 trials of its esketamine nasal spray. Esketamine, a close relative of ketamine, was administered to adults with treatment-resistant depression, as well as one newly initialed oral antidepressant and discovered there was a meaningful rapid reduction in depressive symptoms. Although initial reports of esketamine showed that it had significant initial results, they began to wane after 25 days. Still, this does not detract from the value it could have as a rapid antidepressant while waiting for more traditional treatment to begin working.
Allergan, another pharmaceutical company also has a similarly acting antidepressant in the works called rapastinel. It has currently completed phase 2 trials and starting phase 3 trials in 2019.
The Fast Track
These two antidepressants, which act similarly to ketamine, are currently on the FDA fast track for approval. One of the hardest things about developing new helpful drugs is that it has to pass all the safety tests. The FDA realizes this, which is why it fast tracks certain drugs.
According to their website, the “Fast track is a process that facilitates the development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.”
The FDA looks at a number of factors when determining whether a drug should be fast-tracked. They indicate they look at things like survival, day-to-day- function, and likelihood that the condition will get worse if untreated. They highlight a few examples such as AIDS, Alzheimer’s, cancer, and depression. A big thing they factor into the decision is whether there is an unmet medical need for the drug. All medical professionals agree that there need to be newer and better options in the treatment of depression. And it appears that the FDA agrees with this.
Ketamine infusion therapy has been proven to be highly effective in treating a number of mental conditions. The two drugs on the fast track are looking to address depression. Once they get approval, the possibilities are endless. Hopefully, these new drugs will make an impact on those who suffer from depression every day.
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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.