Seelos Therapeutics Receives FDA Fast Track Designation for Intranasal Racemic Ketamine (SLS-002)
2019年11月18日 - 10:00PM
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 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. (Nasdaq: SEEL) 300 Park
Ave., 12th Fl New York, NY 10022 (646) 293-2136
anthony.marciano@seelostx.comhttps://seelostherapeutics.com/https://twitter.com/seelostxhttps://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
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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
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Carson AJ, Sharpe M, Lawrie SM. Psychological autopsy studies of
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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
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