Company developing NRX-101 – first potential treatment for Acute Suicidal Ideation in Bipolar Depression
Wilmington, Delaware & Tel Aviv, Israel , Feb. 10, 2017 (GLOBE NEWSWIRE) — NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute Suicidal Ideation and Behavior (ASIB), today announced that Jonathan Javitt, Ph.D., M.D., Chief Executive Officer, will provide a corporate overview at BIO CEO & Investor Conference, being held on February 13-14, 2017 at the Waldorf Astoria in New York City. In addition, the company is available to conduct one-on-one meetings with registered attendees of the conference; meetings can be requested through the Bio partnering system.
BIO CEO & Investor Conference Presentation Details
Date: Monday, February 13
Time: 4:30pm Eastern Time
Location: Park North Ballroom
About Bipolar Depression and Acute Suicidal Crisis
Bipolar disorder, which affects 5.7 million Americans, is characterized by significant changes in mood, from mania or hypomania, to depression, often quite severe. The depressive phase, which is called “bipolar depression” and is distinct from the unipolar depression of major depressive disorder, can trigger thoughts of suicide (suicide ideation). For some patients, these thoughts can become strong, creating an urge to develop a plan and/or act upon them, making Acute Suicidal Ideation and Behavior (ASIB) in bipolar depression a uniquely lethal disease.
Bipolar patients experiencing acute suicidal crisis, as classified by FDA-recognized scales, have a 33% chance of death within six months. Many patients do seek medical care, or are brought to care by families and physicians, yet there is no approved medicine for the treatment of acute suicidal crisis. Standard of care consists of hospitalized observation and electroconvulsive therapy (ECT). In fact, most commonly used antidepressants bear an FDA-mandated warning label identifying the potential to increase the risk of suicide. Studies show that patients are at continued high-risk for suicide after hospitalization for a suicide attempt.
Each day, approximately 100 Americans, and more than 2,100 people worldwide, end their lives by suicide, according to American Foundation for Suicide Prevention (AFSP) and the World Health Organization (WHO). NeuroRx estimates that more than half of all suicides may be related to bipolar disorder.
NRX-101 is a potentially rapid-onset and sustained oral treatment regimen in a phase 2b/3 pending clinical trial for Acute Suicidal Ideation and Behavior (ASIB) in patients with bipolar depression. The treatment, which is currently investigational, is a patented, oral, fixed-dose combination of two FDA-approved drugs: d-cycloserine, a N-methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, a 5-HT2a receptor antagonist. NeuroRx’s investigational treatment approach begins with a single dose of ketamine, an FDA-approved anesthetic, for initial stabilization, followed by approximately six weeks of daily oral NRX-101. Results from two Phase II clinical studies, involving 26 and 8 patients respectively, have been published in peer-reviewed journals. Findings showed a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation in bipolar patients who were on background antidepressant therapy and then treated with d-cycloserine, one of the active ingredients in NRX-101.
About NeuroRx, Inc.
NeuroRx, Inc. is developing NRX-101, the first oral therapeutic for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in bipolar depression. There is no approved drug for patients with suicidal ideation / behavior. Most antidepressants, including the SSRI class, carry an FDA black box warning for increased risk of suicide, leaving hospitalization and electroshock therapy (ECT) as the standard of care for bipolar patients experiencing a suicidal episode.
NeuroRx draws upon 30 years of basic science and clinical expertise in the role of the N-methyl-D-aspartate (NMDA), a receptor that regulates human thought processes, particularly depression and suicidality. NeuroRx is currently initiating a Phase 2b/3 clinical trial of NRX-101 for the treatment of Acute Suicidal Ideation & Behavior (ASIB) in patients with bipolar depression, the depressive phase of bipolar disorder in which most suicide attempts occur.