Seelos Therapeutics Schedules Type C Meeting with FDA to Discuss Intranasal Racemic Ketamine Program (SLS-002)
NEW YORK, Jan. 06, 2020 (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 scheduling of a Type C meeting with the U.S. Food and Drug Administration (FDA) in March 2020.
Seelos will seek guidance for an adaptive Phase III trial of SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
“Continued communication with FDA is essential for the development of SLS-002 in this high unmet need of ASIB in MDD. We are diligently striving to advance the program forward as we share the Phase I data from the ongoing studies throughout the first quarter,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos.
Seelos recently received Fast Track designation for SLS-002 for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
Data from the ongoing Phase I studies of SLS-002 to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions (DDI) is expected throughout the first quarter of 2020.
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 the scheduling of a Type C meeting with the FDA, the primary objectives and results of the Phase I studies of SLS-002 to evaluate the PK, PD and DDI and expectations regarding the timing for receiving data from the Phase I studies of SLS-002. These statements are based on Seelos’ 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 its product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its 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.
Anthony Marciano Head of Corporate Communications Seelos Therapeutics, Inc. (Nasdaq: SEEL) 300 Park Ave., 12th Fl New York, NY 10022 (646) 293-2136 email@example.com://seelostherapeutics.com/https://twitter.com/seelostxhttps://www.linkedin.com/company/seelos