Breakthrough Therapy Designation


If something receives a breakthrough therapy designation, the designation is designed to expedite the approval process. Typically, this designation is given if there is preliminary clinical evidence that a therapy being developed has the potential to significantly improve existing treatments or create a new category of effective treatment altogether. There are numerous examples of substances being given a breakthrough therapy designation over the years, with one example being the esketamine nasal spray Spravato. This treatment was found to be particularly effective at treating depression, so it was given a breakthrough therapy designation to fast-track it through the approval process. After being given a breakthrough therapy designation, the treatment can still be given full approval by the FDA down the road.

If you or someone you know is in immediate distress or is thinking about hurting themselves, call or text the National Suicide Prevention Lifeline toll-free: Call:1-800-273-TALK (8255) Text: HELLO to 741741

Let’s get you back to being you

Zero barriers. Deeper healing. More progress.
Realize Your Breakthrough
A woman with a smile waring a green top and beaded necklaces