Seelos Therapeutics Announces the Participation of Acadia Healthcare in the Registration Directed Study of SLS-002 (Intranasal Racemic Ketamine) for Acute Suicidal Ideation and Behavior in Patients with Major Depressive Disorder

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the participation of Acadia Healthcare Company, Inc. (Nasdaq: ACHC) in the registration directed Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder.

“The Seelos program shows significant promise for the potential treatment of suicidal patients,” said Dr. Michael Genovese, M.D., Chief Medical Officer of Acadia Healthcare. “As the largest stand-alone behavioral health hospital network in the U.S., we feel it is very important that we play a role in this innovative study.”

Seelos’ registration directed study is currently enrolling in Part 2, a randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the efficacy, safety, and tolerability of repeat doses of SLS-002 (intranasal racemic ketamine) in addition to standard of care on the symptoms of MDD and suicidality in patients who are assessed to be at an imminent risk of suicide.

Acadia is a leading provider of behavioral healthcare services across the United States. As of June 30, 2022, Acadia operated a network of 239 behavioral healthcare facilities with approximately 10,600 beds in 39 states and Puerto Rico. With more than 22,500 employees serving approximately 70,000 patients daily, Acadia is the largest stand-alone behavioral health company in the U.S. Acadia provides behavioral healthcare services to its patients in a variety of settings, including inpatient psychiatric hospitals, specialty treatment facilities, residential treatment centers and outpatient clinics.

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder and in Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. Seelos looks to address an unmet need for a therapy to treat suicidality in the U.S. with SLS-002. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 includes two parallel healthy volunteer studies (Phase I), followed by pivotal registration studies after meeting with the FDA. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company’s robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Sanfilippo syndrome, Parkinson’s Disease, other psychiatric and movement disorders plus orphan diseases.