About the Investigational Study Medicine [SPT-300]
The study medicine [SPT-300] is an investigational medicine. This means that it has not yet been approved for the treatment of Major Depressive Disorder (MDD) by regulatory agencies such as the US Food and Drug Administration (FDA). Investigational drugs require clinical studies, like BUOY-1, to collect enough data to show that a new medicine is safe and effective enough to be available to a broad population.
About the Investigational Study Medicine [SPT-300]
The study medicine [SPT-300] is a new form of allopregnanolone attached to a fat-like molecule. Allopregnanolone is naturally made by the brain, where it works on brain receptors that help to regulate mood and stress. Allopregnanolone would be a new way to treat MDD. An injection of allopregnanolone was approved for use in a type of depression characterized by high anxiety and acute onset.
However, that form of allopregnanolone is not well absorbed as a pill, meaning very little medicine gets into the body if taken as a pill. The study medicine [SPT-300] works differently to get allopregnanolone into the body. That allows allopregnanolone to be available as a once-daily oral pill. Find out more about this technology at https://seaporttx.com/our-pipeline/.
If you are facing emotional distress, crisis or suicidal thoughts, please consider using the following resources for immediate support: