Suicide continues to grow at an alarming rate in the U.S. Suicide rates increased 30% between 2000 and 2018, according to data from the Centers for Disease Control and Prevention.
Suicide is a leading cause of death in the United States, with 45,979 deaths in 2020. This is about one death every 11 minutes. The number of people who think about or attempt suicide is even higher. In 2020, an estimated 12.2 million American adults seriously thought about suicide, 3.2 million planned a suicide attempt, and 1.2 million attempted suicide.
Serious intervention is needed. Yet many of the available pharmaceutical treatments have a side effect that causes a lot of discussion among patients and their prescribing doctors: increased thoughts or actions of suicide. Examples include common antidepressants Rexulti, Caplyta, Zoloft, and Cymbalta.
Researchers are stumped about what causes this side effect. “The mechanism by which antidepressant drugs might increase suicidal thinking, suicidal behavior, and suicide is not yet established,” one study included.
Novel treatments are required. That’s where psychedelics come in.
One of the first psychedelics companies to address the growing menace of treating and controlling suicide is Seelos Therapeutics (Nasdaq: SEEL), a New York-based clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases.
Seelos has developed an unusual formulation of ketamine delivered intranasally, racemic ketamine, designated as SLS-002, that is designed to specifically treat the symptoms of suicidality associated with major depression.
In the open-label portion of their ongoing registrational study in 2021, SLS-002 showed positive data demonstrating rapid and significant treatment effect and a well-tolerated safety profile. Patients were given 90 milligrams of intranasal racemic ketamine SLS-002 in an open label manner twice per week, receiving five total doses.
Nearly all, 94%, of the patients had a meaningful improvement after one dose on the measurement scale of suicidal symptoms; after the full course of treatment, 100% showed meaningful improvement in the depression and suicidal ideation and behavior measurements.
Seelos is continuing this study and plans to complete it by the end of 2022.
Raj Mehra, chairman, founder, and CEO of Seelos, told Psychedealia that Seelos thought they should focus their suicide treatment outreach on patients who are showing up in the emergency room and were trying to end their lives.
“They are captives, for lack of a better term, for at least three to five nights, if not more. Last year, we heard from one physician that he’s holding some suicide patients for 24 days in the ER because he could not find a psychiatric bed,” he said. “They will do the psychiatric evaluation, and, to the extent they can as clinicians, make the judgment that these patients are stable enough to be released back into the society, they will release them. Then it’s good luck to you after that. They have not really treated their underlying disorder.”
He said that 60%-65% of the suicide ideation cases will have major depression. “Over time, if they’re not treated effectively, they will start to think about suicide. These folks think about it constantly,” he said.
If they get caught trying to commit suicide by a family member or friend, they will end up in an emergency room where the doctor will give them more of their antidepressant, which causes them more problems because of the suicide side effect.
“So those are the wrong drugs, but that’s all the ER doctors have available,” he said. “Then on top of that, almost all the antidepressants take six to eight weeks before they really start working. But here’s a patient in the ER who’s imminently suicidal.”
In their study with SLS-002, after a single dose of ketamine delivered through a nasal spray, they saw a measurement on a scale that measures the level of depression that had never been shown by any antidepressant in the history of antidepressant drugs, he said. “More importantly, the effect sizes shown on day one was higher than what people don’t even show in four weeks on antidepressants. So yes, it’s the psychedelic doing the work. But it’s a unique molecule.”
The SLS-002 finally “gives people hope,” he said. “There are so many media reports about the pandemic and post-pandemic, and the increase in suicidality. There was so much doom and gloom. We show that there is help, and at least give people some hope that the psychedelics industry is not just ignoring this.”