Medical

Ketamine-inspired nasal spray for depression on cusp of landmark FDA approval

After an overwhelmingly positive vote from an advisory committee the FDA may approve the new drug within a few weeks
After an overwhelmingly positive vote from an advisory committee the FDA may approve the new drug within a few weeks
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After an overwhelmingly positive vote from an advisory committee the FDA may approve the new drug within a few weeks
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After an overwhelmingly positive vote from an advisory committee the FDA may approve the new drug within a few weeks

A new nasal spray for depression, utilizing a novel drug called esketamine, has passed the last step on its way to final FDA approval. An advisory panel to the Food and Drug Administration (FDA) voted in favor of the new drug's risk/benefit profile meaning the ketamine-inspired treatment may be finally approved for clinical use within the next month.

Originally developed decades ago as a novel anesthetic, ketamine has been undergoing a renaissance in recent years. Many scientists are suggesting this drug exerts a unique action on the brain and can result in stark and rapid anti-depressant effects. As the drug is already approved for clinical use in the United States, "ketamine clinics" have been popping up across the country, administering the drug to patients for a variety of off-label uses.

Of course in the world of Big Pharma there is no money to be made investing in clinical trials for a decades-old drug past its patent. So in comes esketamine, a chemical cousin of ketamine with many similar pharmacological actions. Esketamine is roughly twice as strong as ketamine, eliminated by the body faster, and allegedly presents less negative dissociative symptoms when compared to its relative. For the most part, esketamine acts on the brain in similar ways to ketamine, except it doesn't influence a few key neurological receptors.

Johnson & Johnson has been developing an esketamine-based nasal spray to treat depression for several years. The treatment's development process has been undeniably rocky with two major clinical trials failing to prove the drug is more effective than placebo and some experts questioning its ultimate efficacy.

Ahead of a final FDA decision, expected by early March, an independent advisory committee was recently established to offer a recommendation on the treatment's efficacy. After evaluating a multitude of research submitted by the pharmaceutical company, the committee overwhelmingly voted 14-to-2 in favor of recommending the treatment.

The FDA's ultimate decision is not bound by this recommendation but at this stage, considering the treatment's overwhelmingly positive vote and its Breakthrough Therapy Designation from 2016, it would be a surprise if it doesn't get approved over the coming weeks. If approved, this will be the first new major depression treatment to be introduced for clinical use in over 30 years.

Source: Janssen Pharmaceutical Companies of Johnson & Johnson

2 comments
paul314
" The treatment's development process has been undeniably rocky with two major clinical trials failing to prove the drug is more effective than placebo " But because it's on-patent, marketing continues apace, apparently.
sidmehta
Isn't better than a placebo....but the committee "...overwhelmingly voted 14-to-2 in favor...." Capitalism needs a new business model. This one ain't working.