SLS-002

Indicated For

Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), Post-Traumatic Stress Disorder (PTSD)

About This Medication

# Seelos Therapeutics Patient Assistance Program Guide: How to Get SLS-002 (Intranasal Racemic Ketamine) at Low or No Cost SLS-002 is an investigational intranasal racemic ketamine therapy developed by **Seelos Therapeutics, Inc.** for treating **Acute Suicidal Ideation and Behavior (ASIB)** in adults with **Major Depressive Disorder (MDD)** and potentially **Post-Traumatic Stress Disorder (PTSD)**. Currently in clinical trials, no FDA-approved patient assistance program exists, but this guide outlines steps to access it through trials, compassionate use, or future programs while emphasizing urgent mental health support.[1][2][9] ## About SLS-002 (Intranasal Racemic Ketamine) **SLS-002** is a convenient, single-use intranasal device delivering racemic ketamine sprays (0.1 mL per nostril) via a bi-dose liquid system from Aptar Pharma. Unlike traditional antidepressants that may take weeks to work and can sometimes increase suicidal thoughts, SLS-002 showed rapid effects—potentially overnight—in clinical studies, improving depression symptoms (MADRS scores), suicidality (CGIS-SI/B), and other measures in Part 1 (open-label, 17 subjects) and Part 2 (double-blind, placebo-controlled, 147 subjects) of the SLS-002-201 study.[1][7][10] It's targeted at patients with MDD at **imminent suicide risk** (e.g., high S-STS scores, history of attempts per C-SSRS), excluding those with bipolar, psychosis, seizures, or treatment-resistant depression from >4 antidepressant trials.[2][9] Ongoing trials include PTSD studies with the U.S. Army (dosing started late 2024).[4][8] Seelos aims to fill the gap as **no FDA-approved ASIB treatment exists**.[10] **Important Safety Note:** SLS-002 is investigational. If you're in crisis, call the National Suicide Prevention Lifeline at 1-800-273-8255 or go to the ER immediately.[2] ## Who Qualifies? Since SLS-002 lacks a commercial patient assistance program (all provided details like income thresholds and application methods are null or empty), access is primarily via **clinical trials** or potential expanded access. Qualification focuses on medical need: - Adults (18+) with **MDD and imminent suicide risk** (e.g., psychiatric hospitalization risk, S-STS ≥15, clinician-rated high risk).[2][9] - Possible expansion to **PTSD** in military/veteran trials.[4][8] - Exclusions: Bipolar, psychosis, OCD, seizures, intellectual disability, or chronic refractory depression.[2] Contact **SLS002team@seelostx.com** for trial eligibility or compassionate use inquiries.[3][9] Future commercial programs may follow FDA approval. ## Income Eligibility Breakdown No specific income thresholds (e.g., FPL percentage) are published for SLS-002. Seelos Therapeutics has not detailed a traditional PAP with limits like 400-500% FPL common in other programs. Monitor for updates post-approval. For reference, here's a general table of common PAP income structures (not SLS-002 specific): | Household Size | Typical Max Income (400% FPL) | Notes | |---------------|-------------------------------|-------| | Individual | $60,240 | Annual, varies by program | | Couple | $81,760 | - | | Family of 3 | $103,280 | - | | Family of 4 | $124,800 | Add ~$21,520 per additional member | Contact Seelos for any emerging criteria.[3] ## Insurance Requirements No insurance details available as SLS-002 is trial-based. Trials often cover costs regardless of insurance; standard care continues alongside. Medicare/Medicaid patients may qualify for trials. Post-approval, expect requirements like government insurance exclusion (common in PAPs).[2] ## Step-by-Step Application Process 1. **Consult Your Doctor:** Discuss SLS-002 suitability. They assess suicide risk via scales like MADRS, S-STS, C-SSRS.[1][2] 2. **Contact Seelos Team:** Email **SLS002team@seelostx.com** or visit seelostherapeutics.com/patients-and-caregivers for trial info (e.g., NCT04669665).[3][9] 3. **Screening:** Undergo evaluation (30-day screening for some trials).[4] 4. **Enroll if Eligible:** Trials include treatment (e.g., 12 weeks) + follow-up; costs covered.[2][4] 5. **For Non-Trial Access:** Inquire about Expanded Access (if available pre-approval). 6. **Follow-Up:** Trials monitor safety closely.[2] No formal PAP application URL/phone listed; use clinicaltrials.gov for sites.[2] ## Timeline and Delivery Trial timelines: Screening (up to 30 days), treatment (e.g., 12 weeks), follow-up (4 weeks).[4] Top-line data from prior studies expected quarterly; new PTSD dosing in 2024.[4][10] Delivery: Intranasal device, clinician-administered in trials. No PAP processing time specified—assume trial-dependent (weeks to months).[2] ## Alternatives if Denied or Ineligible - **Other Ketamine Options:** Esketamine (Spravato) PAP via Janssen (income-based).[External knowledge] - **Trials:** Check clinicaltrials.gov for ketamine/MDD studies. - **Standard Care:** Antidepressants, ECT, therapy—seek immediate help. - **Other PAPs:** NeedyMeds.org or RxAssist.org for depression meds. - **Biosimilars:** None listed for SLS-002. ## Disclaimer This guide is for informational purposes based on public data as of 2026. SLS-002 is **not FDA-approved**; access is trial-limited. No guaranteed PAP exists—details may change. Consult healthcare providers; this is not medical advice. Seelos not liable for outcomes. For crises: 1-800-273-8255.[1][2][3] (Word count: 912)

Program information last verified: March 30, 2026