A Department of Defense (DOD) Health Agency-funded adaptive platform trial for alternative treatments for PTSD will test SLS-002 on some 600 active-duty service members and veterans. The intranasal racemic ketamine was developed by biotech company Seelos Therapeutics (NASDAQ:SEEL)
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The Study
The new Phase 2 study will use an adaptive platform trial design involving a 30-day screening period, a 12-week treatment period, and a four-week follow-up to assess safety, tolerability and efficacy of multiple doses of SLS-002 paired with therapy.
Project managers will “guide the development of medical products for th. Army Medical Department and other service branches involved.
The study will assess changes in PTSD symptom severity and other endpoints like incidence of new or worsening suicidal thoughts or behaviors.
SLS-002, derived from a Javelin Pharmaceuticals Inc./Hospira Inc. program with 16 clinical studies with 500 participants, aims to address the much-needed suicidality treatment in the U.S.
Seelos is advancing clinical trials and has placed two Investigational New Drug (IND) applications with the FDA for SLS-002’s therapy on acute suicidal ideation and behavior in both Major Depressive Disorder (MDD) and in PTSD.
CEO and chairman Dr. Raj Mehra says the company’s inclusion in this “landmark adaptive platform study” will enable an expedited pursuit of additional treatment indications.
Taking place in Decatur, Georgia, the study is expected to commence soon and be completed by 2026.
PTSD In The US
The incidence of PTSD has increased significantly for veterans of more recent conflicts: 3% for WWII and Korean War veterans, 10% for the Vietnam War, 21% for the Gulf War (Desert Storm,) and 29% for the Iraq war.
Considering PTSD can also be triggered by other traumatic experiences, in 2019 the Agency for Healthcare Research and Quality databases showed over one million visits to emergency rooms for suicide attempts in the U.S. alone.
Experimental studies suggest ketamine could be a rapid and effective treatment for conditions including refractory depression, suicidality and PTSD.
Photo: Benzinga edit with photo by Spotmatik Ltd on Shutterstock and Wikimedia Commons.
