SLS-002 (ketamine)

SLS-002 (IN Ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD)

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Seelos Therapeutics owns rights to Javelin’s post-operative pain program

  • Seven Phase I studies (226 subjects)
  • 16 clinical studies (~500 subjects)

 

Intranasal Ketamine in MDD Demonstrates Statistically Significant Efficacy

Design
Randomized, double-blinded, crossover study, n=20

Dose
IN ketamine hydrochloride (50 mg) or saline solution

Duration
Each treatment period (ketamine or placebo) consisted of 7 days. Assessments occurred at 40min, 120min, 240min, 24 hrs, 48 hrs, 72 hrs and 7 days after the start of treatment intervention

Results
Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo (p<0.001)

Lapidus_MADRS_Ketamine
  • IN ketamine was well tolerated with minimal adverse effects
  • Evidence for the rapid antidepressant effects of IN ketamine

Minimal Dissociative, Psychotomimetic, and Hemodynamic Effects of IN Ketamine and placebo in Treatment-resistant Depression (TRD)

Lapidus_Behaviorial and HD Changes with Footer_Ketamine

Lapidus KA, Levitch CF, Perez AM, et al. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry. 2014;76(12):970-6.

SLS-002 Intranasal Device Administration

Intranasal Administration
  • Bi-dose device administers 0.1 mL sprays in each nostril
  • Disposable device for single use
  • Convenient ready to use administration
  • Non-invasive approach for better compliance
  • Manufactured by Aptar Pharma
    • Leveraging their experience in nasal drug delivery

SLS-002 Has the Potential to Transform the Treatment of Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD)

Large unmet need globally

~800 000 people die due to suicide every year, which is one person
every 40 seconds1

Suicide is the 10th leading cause of deaths in the U.S.
(45,000 lives per year)2

Suicidality overall accounts for ~ 1,000,000 emergency room visits
annually, and over 40% of these patients are admitted3

No efficacious drug
approved

Current treatments include hospitalization and/or anti-depressants – many with black box warning as they lead to increase in suicidal thoughts

Fast acting,
efficacious drug

Most anti-depressants slow acting,
work over weeks;
Ketamine efficacy within hours

Ease of Administration

Bi-dose nasal spray system is non-invasive and convenient

High Regulatory awareness

Given the large unmet need, possibility of fast-track and breakthrough designations; Suicidality is a FDA-coined term

Esketamine nasal spray now approved in U.S.4

Five pivotal Phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression: three short-term studies, one withdrawal maintenance of effect study, and one long-term safety study

  1. Source: Mental Health Suicide Data. World Health Organization. Available at: https://www.who.int/mental_health/prevention/suicide/suicideprevent/en/ Accessed February 2019.
  2. Source: Suicide Rising Across the US. National Center for Injury Prevention and Control. Available at: https://www.cdc.gov/vitalsigns/suicide/ Accessed February 1, 2019.
  3. Owens PL (AHRQ), Fingar KR (IBM Watson Health), Heslin KC (AHRQ), Mutter R (SAMHSA), Booth CL (SAMHSA). Emergency Department Visits Related to Suicidal Ideation, 2006-2013. HCUP Statistical Brief #220. January 2017. Agency for Healthcare Research and Quality, Rockville, MD. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb220-Suicidal-Ideation-ED-Visits.pdf.
  4. Johnson & Johnson Press Release. Janssen Announces U.S. FDA Approval of SPRAVATOTM (esketamine) CIII Nasal Spray for Adults with Treatment-Resistant Depression (TRD) Who Have Cycled Through Multiple Treatments Without Relief. Available at: https://www.jnj.com/janssen-announces-u-s-fda-approval-of-spravatotm-esketamine-ciii-nasal-spray-for-adults-with-treatment-resistant-depression-trd-who-have-cycled-through-multiple-treatments-without-relief