Neurocrine Biosciences Initiates Phase 3 Study for Osavampator as an Adjunctive Treatment for Major Depressive Disorder
January 28, 2025 – San Diego, CA – Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a biopharmaceutical company focused on neuroscience and rare diseases, recently announced the initiation of a Phase 3 registrational study for osavampator, an investigational drug being developed as an adjunctive treatment for major depressive disorder (MDD). This announcement comes following the positive topline data from the Phase 2 SAVITRI™ study, which was announced in April 2024.
Background on Osavampator and Major Depressive Disorder
Major depressive disorder (MDD) is a common and debilitating mental illness characterized by persistent feelings of sadness, hopelessness, and loss of interest or pleasure in activities. According to the National Institute of Mental Health (NIMH), approximately 16.5 million adults in the United States have had at least one major depressive episode in the past year.
Despite the availability of various antidepressant medications, many patients do not achieve adequate symptom relief. This has led to the development of adjunctive treatments, which are used in combination with antidepressants to improve treatment outcomes. Neurocrine Biosciences’ osavampator is one such investigational adjunctive treatment for MDD.
Phase 3 Study Design
The Phase 3 registrational study, named SAVANTA™, is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy, safety, and tolerability of osavampator in adult subjects with MDD who have an inadequate response to antidepressant therapy. The study will enroll approximately 500 participants and will be conducted at over 100 sites in the United States and Europe.
Impact on Individuals
For people living with major depressive disorder, the initiation of this Phase 3 study represents a potential new treatment option. If successful, osavampator could offer relief to those who have not responded adequately to current antidepressant therapies. This could mean improved mood, increased energy levels, and a better quality of life.
Impact on the World
The World Health Organization (WHO) reports that depression is the leading cause of disability worldwide, and it is estimated that depression will be the second leading cause of disease burden by 2030. The development of new and effective treatments for major depressive disorder, such as osavampator, could have a significant impact on individuals’ lives and the overall healthcare system.
Conclusion
Neurocrine Biosciences’ Phase 3 study of osavampator as an adjunctive treatment for major depressive disorder represents an important step forward in the development of new and effective treatments for this debilitating condition. If successful, osavampator could offer relief to those who have not responded adequately to current antidepressant therapies, improving their overall quality of life and potentially reducing the burden of depression on individuals and the healthcare system.
- Neurocrine Biosciences initiates Phase 3 study for osavampator as an adjunctive treatment for major depressive disorder
- Previous positive Phase 2 SAVITRI™ study results announced in April 2024
- MDD affects approximately 16.5 million adults in the US alone
- Osavampator could offer relief to those who have not responded adequately to current antidepressant therapies
- Successful study results could have a significant impact on individuals’ lives and the healthcare system
