Seelos Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its new, investigational intranasal racemic ketamine program, SLS-002, for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
“The decision by the FDA to grant Fast Track designation to SLS-002 underscores the significant unmet medical need for patients with Acute Suicidal Ideation and Behavior in Major Depressive Disorder,” said Raj Mehra, PhD, Chairman and CEO of Seelos. “We will be working diligently in close collaboration with the FDA to finalize the protocol for the proof of concept study and future clinical development.”
“While I was a psychiatrist working in an academic teaching hospital, I saw and treated many of these patients,” Tim Whitaker, MD, Head of R&D at Seelos said. “The limited medical treatment options have been a source of great frustration to patients, their families, and their healthcare practitioners. SLS-002 has promise to help address this critical unmet need. We are encouraged by the FDA's Fast Track designation as this moves the program forward in a meaningful way.”
Data from a Phase I study of SLS-002 to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions (DDI) is expected in the first quarter of 2020.
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Suicide represents the 10th leading cause of death in the US across all age groups and ethnicities according to the CDC. Approximately 1.3 million adults attempt suicide each year in the US and 45,000 of such attempts result in death. Suicide occurs throughout the lifespan and was the second leading cause of death among 15- to 29-year-olds globally in 2016 according to the World Health Organization.
Approximately 90% of all individuals who commit suicide suffer from a diagnosable psychiatric disorder. While suicide ideation and behavior is most commonly associated with MDD, patients with other underlying Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses such as schizophrenia, personality disorders, bipolar disorder, and substance abuse disorders may also exhibit suicide ideation and behavior. It is estimated that the incidence of attempted suicide is about 20-fold higher in patients with MDD compared with the general population. Major depression is one of the most common mental disorders, with an estimated 17.3 million adults in the US (7.1% of all US adults) experiencing at least one major depressive episode in 2017.