SLS-002 Intranasal Ketamine Depression Drug Granted Fast Track Status by FDA

Seelos FDA Ketamine News
Seelos FDA Ketamine News


Seelos Therapeutics Inc (NASDAQ:SEEL) stock soared Monday after its SLS-002 intranasal ketamine depression drug aimed at patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at risk of committing suicide, was granted fast track designation by US regulators.

The US Food and Drug Administration (FDA) granted the status for the development of the drug for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with major depressive disorder.

Investors responded well, sending shares in the New York clinical-stage biopharmaceutical company nearly 10.2% higher to $0.95 in morning trade.

“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 Seelos CEO Raj Mehra.

“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,” added Mehra.

Speeds up drug development

The FDA’s fast track program is designed to speed up the development and review of new medicines for the treatment of serious conditions where there is an unmet need.

“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,” said Tim Whitaker, head of R&D at Seelos Therapeutics.

“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,” he added.

Data from a Phase I study of SLS-002 to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions are expected in the first quarter of 2020.

Suicide represents the tenth leading cause of death in the US, according to the Centers for Disease Control and Prevention with nearly 1.3 million adults attempting suicide each year and 45,000 of such attempts result in death.

Wall Street is bullish that Seelos Therapeutics’ SLS-002 intranasal ketamine depression drug under development is safe and will reach millions of patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at imminent risk of committing suicide.

Far more potent 

Johnson & Johnson’s (NYSE:JNJ) J&J’s nasal spray SPRAVATO and Seelos’ SLS-002 nasal spray both have formulations of ketamine, with subtle differences. J&J’s nasal spray contains the esketamine compound, which is one half of the ketamine compound. However, Seelos Therapeutics’ nasal form of racemic ketamine is made of two mirror-image molecules and is likely to be given at a lower dose because it is far more potent.

A Zanos publication shows in the animal depression model, that racemic/R ketamine has more potency and minimal side effects versus S-ketamine. The R isomer also lacks the negative psychoactive effects associated with ketamine.


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