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Trial Underway Testing Suicide-Prevention Nasal Spray

Sad, depressed

(Daniel Reche, Pixabay)

6 July 2021. A clinical trial testing a nasal spray against a placebo to prevent suicide from depression enrolled its first participants considered at high risk of suicide. The trial is conducted by Seelos Therapeutics Inc., based in New York, evaluating its therapy candidate code-named SLS-002.

Suicide, according to Centers for Disease Control and Prevention, is the 10th leading cause of death in the U.S., responsible for more than 47,500 deaths in 2019, an increase of 33 percent since 1999. CDC reports in 2019, more than 12 million people thought about committing suicide, with 3.5 million planning, and 1.4 million attempting a suicide. Depression is considered a factor that increases the risk for suicide. Depression, says CDC, affects 4.7 percent of adults in the U.S., as well as more than nine percent of patients making doctors’ visits and 11 percent of individuals visiting hospital emergency rooms. National Suicide Prevention Hotline: 1-800-273-TALK (1-800-273-8255).

Seelos Therapeutics is a biopharmaceutical company developing treatments for central nervous system and rare diseases. SLS-002 is among the company’s lead products, designed as a therapy for suicide ideation and behavior from depression and post-traumatic stress disorder. The therapy is derived from racemic ketamine, approved and used mainly as an anesthetic, but sometimes prescribed off-label for pain relief and depression. Because of its hallucinogenic, tranquilizing and dissociative effects, ketamine is sometimes abused as a recreational drug.

Single-use fast-acting nasal spray

Ketamine is believed to bind to N-Methyl-D-aspartate, or NMDA receptors, molecules found in synapses, the part of nerve cells that permit sending and receiving of signals. NMDA receptors help keep synapses flexible, which affects memory, learning, and development of the central nervous system. This binding action releases glutamate, a neurotransmitter in the brain and other proteins that help neurons communicate, and also reduce inflammation associated with depression.

Ketamine is usually given as an anesthetic in infusion or injection form. SLS-002 however is formulated and packaged as a single-use fast-acting nasal spray. The clinical trial is enrolling 136 adults diagnosed with major depressive disorder and hospitalized due to high risk of suicide or previous suicide attempts. In the first part of the study, 17 participants tested SLS-002 for signs of adverse effects, but also scores on four standard scales of depression and suicidal thoughts. Findings from that part of the trial, reported by the company and not peer-reviewed, show SLS-002 is well-tolerated with no serious adverse effects from the treatments. Participants also recorded lower scores on the depression and suicidal rating scales after 16 days.

The second stage of the trial tests SLS-002 against a placebo nasal spray. Participants are randomly assigned to receive standard in-patient care for depression, and either SLS-002 twice a week or a placebo for two weeks. The study team is looking primarily at changes in the Montgomery-Åsberg depression rating scale that measures depression severity on a range of variables, including suicidal thoughts. The researchers are also tracking scores on three other scales of suicidal thoughts.

“SLS-002’s potential to have a rapid onset of efficacy, as was suggested in Part 1 of our study,” says Seelos Therapeutics CEO Raj Mehra in a company statement, “aims to show a benefit as quickly as overnight. This could potentially allow for patients to be discharged sooner in the future and treated as an outpatient.” Mehra adds the company “will continue discussions with the FDA on the regulatory pathway going forward.”

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