ACCORDING TO DATA, the US government has been spending more than $70 billion on suicides and suicide attempts, according to data from the Centers for Disease Control and Prevention (CDC). Additionally, a suicidal patient has to wait for an average of 10 days before hospitalization due to the current shortage of over 120,000 inpatient psychiatric beds. However, results from a study by Seelos Therapeutics, Inc. (NASDAQ: SEEL) of SLS-002 are likely to bring quick solutions in treating suicidal patients.
The biopharma announced the dosing of the first patient in Part 2 of the registration study of the intranasal racemic ketamine. Thus, the possible treatment for Acute Suicidal Ideation and Behavior in Major Depressive Disorder has two investigational new drug applications. In Part 1 of the study, which enrolled 17 subjects, the treatment demonstrated a well-tolerated safety profile and clinically meaningful efficacy after a single dose.
The Chairman and CEO of Seelos, Raj Mehra, says that they used the positive data from Part 1 of the study to improve the treatment further and execute Part 2. In addition, information from the FDA indicates that Part 2 could serve as a registrational study for the SLS-002 program.
These are Trying Times, and SLS-002 Could Create a Paradigm Shift
The battle against the suicide epidemic is hard-hitting, and the presence of the COVID-19 global pandemic has only intensified it. However, Mehra is optimistic about the positive rate of SLS-002, citing, “The goal of the development of SLS-002 in treating suicidal patients is to… allow for patients to be discharged sooner in the future and treated as an outpatient….”
There have been 16 clinical studies for SLS-002 under Javelin Pharmaceuticals, Inc. /Hospira, Inc. program, which has engaged approximately 500 subjects. And given that there no approved medication by the regulatory agency for the treatment of suicidal ideation, the Part 2 study aims to demonstrate a benefit from it as quickly as overnight. The findings are expected to bring a historic contribution to the treatment of suicidality.