FDA Grants Fast Track Designation for Seelos Therapeutics’ Intranasal Racemic Ketamine

NEW YORK, Nov. 18, 2019 (GLOBE NEWSWIRE) — 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 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.”

Tim Whitaker, MD, Head of R&D at Seelos added, “While I was a psychiatrist working in an academic teaching hospital, I saw and treated many of these patients. 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.”

According to the FDA, “Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.” 

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.

About Suicide and Suicide Ideation

Suicide represents the 10th leading cause of death in the US across all age groups and ethnicities (CDC 2018). Approximately 1.3 million adults attempt suicide each year in the US and 45,000 of such attempts result in death (CDC 2018). Suicide occurs throughout the lifespan and was the second leading cause of death among 15- to 29-year-olds globally in 2016 (WHO 2018). Prior suicide attempts are strongly correlated with a subsequent successful suicide (Johnsson-Fridell 1996), and the attempts themselves are predicted by suicidal ideation and planning (Weissman 1989).

About Suicide and Major Depressive Disorder

Approximately 90% of all individuals who commit suicide suffer from a diagnosable psychiatric disorder (Cavanagh 2003). 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 (Holma 2010Dadiomov 2019). 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 (NIMH 2019).

About Fast Track Designation

A drug receiving Fast Track designation may eligible for the following:

  • More frequent meetings with the FDA to discuss development plans and data collection
  • More frequent written communications with the FDA
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • Rolling Review which allows for submission of completed sections of its Biologic License Application or New Drug Application (NDA) for review by the FDA rather than being required to complete their full NDA

Check Also

FDA Approves Bayer’s Lampit for the Treatment of Children with Chagas Disease

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer announced today that the United States Food and Drug Administration (FDA) has …