Ketamine, known as Special K on the streets, became an unexpected weapon in the war against depression. Pharmaceutical companies are involved in the development of drugs that improve it or can be associated with it. NeuroRx has made progress with its drug, Cyclidad, which, in combination with ketamine, has the potential to treat bipolar depression, which doctors have struggled to successfully treat.
Ketamine history
Ketamine was first developed in 1962 as a fast-acting anesthetic that is still widely used in operating rooms and for the treatment of pain. Since the 1970s, ketamine has become popular as a recreational drug, known for putting users in the K-hole, comparing them with a body close to death.
Due to abuse in 1999, the American Anti-Drug Administration banned non-medical use of ketamine and designated it as a controlled substance on Schedule III.
According to an article in Bloomberg Business, at about the same time, researchers from Yale University, including Dennis Charney, who is currently the dean of the Icahn School of Medicine on Mount Sinai, came across the promise of a drug as a mood stabilizer. “At the time, we didn't think ketamine would be an antidepressant,” says Charney. When patients began to report that they were suddenly better, scientists were surprised.
The findings of the group, published in Biological Psychiatry in 2000, were largely ignored. The study was tiny, and because of the reputation of ketamine as a party drug, scientists were associated with follow-up. “They didn’t believe that in a few hours you could become better than depression,” adds Charney. "They never saw it." According to the National Institute of Mental Health, standard antidepressants, such as Prozac and Wellbutrin, take weeks or months. Up to 30 percent of depressed patients do not respond to regular anti-depressants.
Ketamine as a treatment
Six years later, Charney, who continued to work at the National Institutes of Health, initiated a replication study with 17 patients. During the day, receiving one infusion of ketamine, 70 percent of the subjects entered remission. Since then, scientists from institutions, including Yale University, Mount Sinai Hospital and Baylor College of Medicine, have conducted dozens of studies confirming the results. Additional studies show that ketamine works by producing long-term changes in the brain, reversing nerve damage caused by stress and depression, and a potentially decreasing level of inflammation and cortisol.
Ketamine continues to be widely distributed in the scientific literature and media, based on the growing popularity of ophthalmic management for the treatment of acute depression. Dr. Kate Ablow praised FoxNews on her blog: “I have now treated about a hundred patients with intravenous ketamine. Low mood, lack of energy, reduced self-esteem, and even suicidal thinking very often inevitably lead to the infusion of ketamine constantly relieving patients from their suffering.
The ketamine success stories I’ve watched include patients who used to wallow in depression and haven’t worked for many years, who returned to their jobs for several weeks of treatment, patients who were anxious made it almost impossible to leave the house, which can now go on vacation, requiring a trip, and young people who were forced to cut themselves off from stress and self-disgust, but now stopped cutting and began to create their own futures. "
Future prospects
The FDA's approval of ketamine for depression depends on multi-phase clinical studies that inadvertently occur. Pharmaceutical companies usually pay for clinical trials and cannot earn money on a ten-year generic drug. “You can get a few years of exclusivity for new use, but as a rule, you need more than a few years to offset the costs of research and development for delivering a drug to the market,” says Michael Tase, professor of psychiatry at the University of Pennsylvania which have been consulted for various pharmaceutical companies developing ketamine-like products.
Instead, companies spend millions on developing similar, patentable drugs. According to Bloomberg Business, Janssen is seeking approval for a nasal spray derived from estetamine, a variation of ketamine molecule that is 20 percent stronger, Manji says. Spray may appear on the market in a few years. Cerecor, based in Baltimore, is developing a pill that reproduces the effects of ketamine. In June, the startup filed an application for publication and attracted $ 31.6 million. Pharmaceutical giant Allergan spent $ 560 million in July on the acquisition of Naurex, an Illinois-based biopharmaceutical company whose main products are two ketamine-like drugs in the clinical stage, called rapaminel and NRX-1074. Both are designed to modulate the same receptor as ketamine, alleviating depression without causing hallucinations.
Instead of replacing, NeuroRx tries to work with it. They claim that Cyclorad can prolong the effect of ketamine in the treatment of acute depression. Writing in the Journal of Clinical Psychiatry, prof. Dan V. Iosifescu of the Icahn School of Medicine stated: “In this context, the study [of Cyclurad] represents an important addition to the emerging literature on maintaining a clinical response after initial treatment with ketamine ... D-cycloserine has several advantages. It can be administered administratively and demonstrate safety and tolerance for long-term use. "
Bipolar depression is the leading cause of disability in the United States. Currently, over three million Americans have bipolar depression. 500 people with this condition tragically end their lives every day. Those who have bipolar depression are more likely to commit suicide than patients who have other forms of depression. Between 25% and 50% will attempt to commit suicide at some point in their lives. In general, patients with resistant to depression for all causes cost the health care system more than $ 120 billion a year.
