Seelos Therapeutics Receives FDA Fast Track Designation for Intranasal Racemic Ketamine (SLS-002)

NEW YORK, Nov. 18, 2019 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. 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 10^th 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 2010; Dadiomov 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

Forward-Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding our expectations regarding the potential benefits of Fast Track designation by the FDA for SLS-002, statements regarding the protocol for the proof of concept study and future clinical development of SLS-002 and expectations regarding the timing for receiving data from the company's phase I study of SLS-002 to evaluate the PK, PD and DDI. These statements are based on the company's current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its clinical studies and not gaining marketing approvals for our product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund our development plans and ongoing operations, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. SEEL
300 Park Ave., 12^th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Centers for Disease Control (CDC 2018). Vital Signs: Trends in State Suicide Rates — United States, 1999–2016 and Circumstances Contributing to Suicide — 27 States, 2015. MMWR Morb Mortal Wkly Rep 2018;67:617–624. Available from: http://dx.doi.org/10.15585/mmwr.mm6722a1.

Word Health Organization (WHO): Suicide Fact Sheet 2018. Available from: https://www.who.int/en/news-room/fact-sheets/detail/suicide

Johnsson Fridell E, Ojehagen A, Träskman-Bendz L. A 5-year follow-up study of suicide attempts. Acta Psychiatr Scand. 1996 Mar;93(3):151-7.

Weissman MM, Klerman GL, Markowitz JS, Ouellette R. Suicidal ideation and suicide attempts in panic disorder and attacks. N Engl J Med. 1989 Nov 2;321(18):1209-14.

Cavanagh JT, Carson AJ, Sharpe M, Lawrie SM. Psychological autopsy studies of suicide: a systematic review. Psychol Med. 2003 Apr;33(3):395-405.

Holma KM, Melartin TK, Haukka J, Holma IA, Sokero TP, Isometsä ET. Incidence and predictors of suicide attempts in DSM-IV major depressive disorder: a five-year prospective study. Am J Psychiatry. 2010 Jul;167(7):801-8.

Dadiomov D, Lee K. The effects of ketamine on suicidality across various formulations and study settings. Ment Health Clin. 2019 Jan 4;9(1):48-60.

The National Institute of Mental Health (NIMH). Mental Health Information - Statistics: Major Depression. Last revised February 2019. Accessed 23 Aug 2019. Available at: https://www.nimh.nih.gov/health/statistics/major-depression.shtml