New Generation Of Antidepressants On FDA Fast Track

By Victoria Kim 06/15/18

The medications, which are still in development, may be able to help those who have not found success with currently available antidepressants.

Doctor testing new drugs for medical purposes

Pharmaceutical companies are honing in on the potential of ketamine and more to provide fast-acting antidepressant relief, Healthline reports.

Two examples are Janssen Pharmaceuticals’ esketamine nasal spray and Allergan’s rapastinel (a different, but similarly-acting antidepressant to ketamine), both which the FDA has granted fast-track approval.

On May 5, Janssen (a subsidiary of Johnson & Johnson) announced findings from Phase 3 trials of its esketamine nasal spray. The study administered esketamine (a close relative of ketamine) to adults with treatment-resistant depression, in addition to a “newly initiated oral antidepressant,” and discovered a “statistically significant, clinically meaningful rapid reduction of depressive symptoms” compared to the placebo.

According to a Johnson & Johnson press release, the yet-to-be-approved esketamine nasal spray has the potential to address a “significant unmet need for the more than 30% of people suffering from major depressive disorder who do not respond to… currently available antidepressants.”

Ketamine is typically administered as a veterinary anesthetic, but off-label use of the drug has become more popular for pain, post-traumatic stress disorder (PTSD), anxiety and depression, according to CNN.

The initial findings of Johnson & Johnson’s research, reported by the BBC in April, found that the nasal spray led to “significant” improvements in depressive symptoms in the first 24 hours. By 25 days, the effects had waned, the report noted, but this does not detract the drug’s potential value as a rapid antidepressant treatment to initiate therapy, said the study’s authors.

Another potential new antidepressant on the fast track for FDA approval is rapastinel, developed by Allergan. Currently the drug has completed Phase 2 trials and is expecting the results of its Phase 3 trials in 2019, according to Healthline.

These “rapid-acting therapies” have the potential to be “game-changing in the treatment of depression,” said Allergan executive vice president and chief research and development officer David Nicholson, PhD, in a statement to Healthline. He continued, “Our studies so far demonstrated rapid onset of efficacy within one day, which lasts days after a single dose and a low potential for abuse.”

Another recent report opens even more possibilities for alternative antidepressant therapies. New research demonstrated that psychedelics (specifically LSD, DMT, MDMA and DOI, an amphetamine) showed positive effects on neural plasticity, meaning that neurons were more likely to branch out and connect with one another.

Ketamine is said to have the same effect.

This is a positive development for people living with depression, anxiety, substance use disorder, and PTSD, since research has shown that their brain plasticity and neurite growth are less active.

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Victoria is interested in anything that has to do with how mind-altering substances impact society. Find Victoria on LinkedIn or Tumblr