Neurocrine Biosciences Unveils Promising Data on Osavampator for Major Depressive Disorder

Neurocrine Biosciences to Present New Data on Osavampator

Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading biopharmaceutical company, has announced its plans to share exciting new data from its Phase 2 SAVITRI study involving osavampator at the upcoming Psych Congress 2025. This annual event will occur from September 17 to 21 in vibrant San Diego, California. The highly anticipated results will be disclosed during a poster presentation at 4:30 PM PT on September 18, under the session titled "Latest Discoveries: Emerging Trends in Major Depressive Disorder (MDD)."

Osavampator (NBI-1065845) is an investigational drug viewed as a potential first-in-class selective positive allosteric modulator of the AMPA receptor. This innovative treatment is designed as an adjunctive option for adults suffering from major depressive disorder who have not fully responded to conventional oral antidepressants. Dr. Sanjay Keswani, the Chief Medical Officer at Neurocrine, has expressed optimism about the findings, stating, "The expanded data we will share at Psych Congress from our Phase 2 SAVITRI study represent an important step forward in understanding and addressing major depressive disorder. We are confident in our osavampator program and its potential to be a first-in-class treatment."

The Phase 2 SAVITRI study involved a rigorous double-blind, placebo-controlled design and aimed to assess the safety and efficacy of osavampator in a well-defined cohort. A total of 183 adult participants, diagnosed with MDD and exhibiting inadequate response to their ongoing antidepressant therapies, were enrolled in this pivotal trial. Following the promising results of the top-line data released in April 2024, Neurocrine Biosciences advanced its development efforts by initiating a Phase 3 registrational program for osavampator earlier this year. This program encompasses five separate studies that are currently in progress.

At Psych Congress, Neurocrine will showcase several posters, which include two notable finalists in the competition for Poster Awards. One of these posters will detail that osavampator has shown statistically significant and clinically meaningful improvements in depression severity, along with a favorable tolerance profile in adults diagnosed with major depressive disorder. The other poster will focus on the functionality of osavampator as a selective positive allosteric modulator of the AMPA receptor, emphasizing its innovative mechanism of action.

Neurocrine’s commitment extends beyond mere data presentation. They aim to contribute to the broader conversation about major depressive disorder, a condition impacting over 21 million individuals in the United States alone, significantly affecting their daily lives, interactions, and overall well-being. According to the World Health Organization, MDD stands as one of the leading causes of disability worldwide and carries a heightened risk for both suicide and self-harm, making improvements in treatment options crucial.

The significant aspect of Neurocrine’s approach is the acknowledgment that many patients with MDD do not achieve symptomatic relief from their first prescribed antidepressants. Therefore, the introduction of a treatment like osavampator holds the potential to transform the management of major depressive disorder by offering hope to those with inadequate responses to standard therapies.

As the presentation date approaches, Neurocrine Biosciences emphasizes the importance of this new data in ushering in a better understanding of MDD and improving therapeutic options available for patients struggling with this debilitating disorder. The company’s focus remains on addressing neurological, neuroendocrine, and neuropsychiatric challenges with a commitment to delivering impactful treatments that can genuinely improve patients’ lives.

For anyone seeking more information about the Phase 3 osavampator studies, detailed findings, and updates will be consistently shared on ClinicalTrials.gov alongside their broader portfolio tracking.

As demonstrated by Neurocrine's active pursuit of advancements in psychiatric treatments, the future may signal significant progress in combating major depressive disorder, and osavampator could play a pivotal role in vitalizing the landscape of mental health therapies.