What To Know
- Aptar’s patented BDS Liquid System has been approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the delivery of other therapeutics and, to date, millions of the Bidose and Unidose (UDS) Systems have been sold and are used daily by thousands of patients worldwide.
- Seelos has completed Part 1, the 16-patient, open-label cohort, of its Proof-of-Concept study, which uses the Aptar BDS Liquid System to deliver 90mg of SLS-002 to patients who are imminently suicidal.
Seelos Therapeutics has announced the signing of an agreement between Seelos and AptarGroup, Inc.for the co-exclusive use and supply of Aptar Pharma’s Bidose (BDS) Liquid System device for Seelos’ intranasal ketamine product candidate, SLS-002, in the investigational development programs for the treatment of suicidality, depression, and Post-Traumatic Stress Disorder (PTSD).
Under the terms of the agreement, Seelos Therapeutics has certain rights to add other undisclosed indications to the Strategic Device Partnership.
Aptar’s patented BDS Liquid System has been approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the delivery of other therapeutics and, to date, millions of the Bidose and Unidose (UDS) Systems have been sold and are used daily by thousands of patients worldwide. Aptar’s BDS Liquid System is ideal for intranasal therapies, like SLS-002, where a precise delivery of active CNS drug formulations is required. The BDS Liquid System is ready-to-use, requiring no priming or shaking, making the device ideal for use in a crisis situation.
“Aptar is a world-class organization and has been an integral partner for our intranasal ketamine program since our inception,” said Raj Mehra Ph.D., Chairman and CEO of Seelos Therapeutics. “This partnership strengthens the collaboration between Seelos and Aptar, and further protects the SLS-002 franchise.”
The Strategic Device Partnership covers Seelos’ use of Aptar’s BDS Liquid System with its SLS-002 program, which is currently in development for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
Seelos has completed Part 1, the 16-patient, open-label cohort, of its Proof-of-Concept study, which uses the Aptar BDS Liquid System to deliver 90mg of SLS-002 to patients who are imminently suicidal. Part 1 of the Proof-of-Concept study precedes Part 2, which is a registrational double blind placebo-controlled trial.
Seelos expects to release key open-label data in the second quarter of 2021, after analyzing the data received from Part 1 of the study. The last patient completed Part 1 of the study on March 30, 2021.
If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.