SAN
DIEGO, Jan. 28, 2025 /PRNewswire/ --
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today
announced the initiation of a Phase 3 registrational study to
evaluate the efficacy, safety and tolerability of osavampator
(formerly NBI-1065845), an investigational drug under development
as an adjunctive treatment to antidepressants for major depressive
disorder (MDD). Positive topline data for the Phase 2 SAVITRI™
study of osavampator in adult subjects with MDD were announced in
April 2024.
"Osavampator has the potential to become a first-in-class
treatment for MDD, a disorder that impacts more than 21 million
people in the United States," said
Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine
Biosciences. "More than a third of those MDD sufferers endure
debilitating symptoms that current treatment options cannot fully
resolve."
The Phase 2 SAVITRI study with osavampator met its primary and
secondary endpoints, and was generally well tolerated.
"Major depressive disorder is a condition that has a profound
effect on patients and their families and is associated with
significant morbidity and mortality," said Maurizio Fava, M.D., Chair, Mass General Brigham
Academic Medical Centers Department of Psychiatry. "The great
majority of patients suffering from major depressive disorder do
not achieve a sustained remission of their condition and the
options for next step strategies to help them are quite limited.
This trial is happening at a time when it is clear that, as a
field, we need to develop new augmentation strategies to enhance
the efficacy of standard antidepressants."
About Osavampator and the Phase 3 Registrational
Program
Osavampator (formerly NBI-1065845) is a potential
first-in-class, investigational
alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA)
positive allosteric modulator (PAM) in development as a potential
treatment for patients with inadequate response to treatment in
MDD. Neurocrine received an exclusive license to osavampator
from Takeda Pharmaceutical Company Limited for all indications in
all territories worldwide except Japan.
The Phase 3 registrational program is designed to assess the
efficacy, safety and tolerability of osavampator in adult
subjects with MDD. The study will enroll adults with a primary
diagnosis of MDD, who have inadequate response to current
antidepressant treatment. For more information about the Phase 3
osavampator study, click here.
About Major Depressive Disorder
Major depressive disorder (MDD) is a serious disorder
characterized by a persistently depressed mood, loss of interest,
poor concentration, and decreased energy, among other symptoms.
According to the World Health Organization, MDD is one of the
leading causes of disability, is a serious condition that presents
an increased risk of suicide and self-harm, and is associated with
increased all-cause mortality rates. More than 21 million
people in the U.S. live with MDD and it is estimated that roughly a
third of those do not respond to available antidepressants.
About Neurocrine Biosciences
Neurocrine Biosciences is a leading neuroscience-focused,
biopharmaceutical company with a simple purpose: to relieve
suffering for people with great needs. We are dedicated to
discovering and developing life-changing treatments for patients
with under-addressed neurological, neuroendocrine and
neuropsychiatric disorders. The company's diverse portfolio
includes FDA-approved treatments for tardive dyskinesia, chorea
associated with Huntington's disease, classic congenital adrenal
hyperplasia, endometriosis* and uterine fibroids*, as well as a
robust pipeline including multiple compounds in mid- to late-phase
clinical development across our core therapeutic areas. For three
decades, we have applied our unique insight into neuroscience and
the interconnections between brain and body systems to treat
complex conditions. We relentlessly pursue medicines to ease the
burden of debilitating diseases and disorders, because you deserve
brave science. For more information,
visit neurocrine.com, and follow the company on LinkedIn, X
(formerly Twitter), and Facebook.
(*in collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE
SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.
SAVITRI is a trademark of Neurocrine Biosciences, Inc.
Forward-Looking Statements
In addition to historical facts, this press release contains
forward-looking statements that involve a number of risks and
uncertainties. These statements include, but are not limited to,
statements regarding the safety, efficacy, and therapeutic
potential of NBI-1065845; and the results, conduct, and timing of
our NBI-1065845 Phase 3 clinical study. Factors that could cause
actual results to differ materially from those stated or implied in
the forward-looking statements include, but are not limited to, the
following: risks that clinical development activities may not be
initiated or completed on time or at all, or may be delayed for
regulatory, manufacturing, or other reasons, may not be successful
or replicate previous clinical trial results, may fail to
demonstrate that our product candidates are safe and effective, or
may not be predictive of real-world results or of results in
subsequent clinical trials; risks that regulatory submissions for
our product candidates may not occur or be submitted in a timely
manner; our future financial and operating performance; risks
associated with our dependence on third parties for development,
manufacturing, and commercialization activities for our products
and product candidates, and our ability to manage these third
parties; risks that the FDA or other regulatory authorities may
make adverse decisions regarding our products or product
candidates; risks that the potential benefits of the agreements
with our collaboration partners may never be realized; risks that
our products, and/or our product candidates may be precluded from
commercialization by the proprietary or regulatory rights of third
parties, or have unintended side effects, adverse reactions or
incidents of misuse; risks associated with U.S. federal or state
legislative or regulatory and/or policy efforts which may result
in, among other things, an adverse impact on our revenues or
potential revenue; risks associated with potential generic entrants
for our products; and other risks described in the Company's
periodic reports filed with the Securities and Exchange Commission,
including without limitation the Company's quarterly report on Form
10-Q for the quarter ended September 30,
2024. Neurocrine Biosciences disclaims any obligation to
update the statements contained in this press release after the
date hereof other than required by law.
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SOURCE Neurocrine Biosciences, Inc.
