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Seelos to seek FDA guidance on Phase III trial for SLS-002 ketamine depression drug

It will seek guidance from the FDA in March for an adaptive Phase III trial of SLS-002

Seelos Therapeutics - Seelos Therapeutics Inc schedules FDA meeting on Phase III trial for SLS-002 ketamine depression drug
Data from ongoing Phase I studies of SLS-002 are expected throughout the first quarter of 2020

Seelos Therapeutics Inc (NASDAQ:SEEL) announced Monday that it has scheduled a meeting with federal regulators as it advances its SLS-002 intranasal racemic ketamine depression drug. 

In a statement, the company said in March, it will seek guidance from the US Food and Drug Administration (FDA) 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,” said CEO Raj Mehra. 

READ: Seelos starts dosing in Phase I study of SLS-002 intranasal ketamine depression drug

“We are diligently striving to advance the program forward as we share the Phase I data from the ongoing studies throughout the first quarter,” he added.

Seelos, based in New York, recently received Fast Track designation for SLS-002 for the treatment of ASIB in patients with MDD.

Data from the ongoing Phase I studies of SLS-002 to evaluate the pharmacokinetics, pharmacodynamics, and drug-drug interactions are expected throughout the first quarter of 2020.

Seelos' stock recently traded 7.5% higher to $1.43 a share in New York. 

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