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WILMINGTON, Del., Jan. 3, 2018 /PRNewswire/ -- NeuroRx, a clinical stage biopharma company developing the first drug regimen to treat Severe Bipolar Depression in patients with Acute Suicidal Ideation & Behavior (ASIB), announced that it has retained J.P. Morgan as financial advisor. NeuroRx is developing a sequential treatment regimen of NRX-100 (ketamine) and NRX-101 (a proprietary formulation of d-cycloserine / lurasidone), and will begin enrolling patients shortly in a Phase 2b/3 pivotal study targeting severe bipolar depression in patients with ASIB. The FDA awarded FAST TRACK designation to this investigational drug regimen in August, 2017. There currently is no approved drug therapy for bipolar depression in patients with Acute Suicidal Ideation and Behavior, the only FDA-approved treatment is electroconvulsive therapy (ECT).  In fact, most antidepressants bear a warning about their potential to increase the risk of suicide. 

Jonathan Javitt, M.D., M.P.H., NeuroRx Founder and Chief Executive Officer, will provide a company update at the upcoming annual J.P. Morgan Healthcare Conference in San Francisco, CA,  on January 10^th, at 3:30 PST at the Westin St. Francis Hotel, San Francisco, CA. In addition, the company is available to conduct one-on-one meetings with registered attendees of the conference. The presentation will be webcast.

About Bipolar Depression and Acute Suicidal Ideation & Behavior

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," can trigger suicidal thoughts  and behaviors. Standard-of-care consists of hospitalized observation and electroconvulsive therapy (ECT). Unfortunately, most commonly-used antidepressants bear an FDA-mandated warning label identifying their potential to increase the risk of suicide.

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). Although only 10% of all people with depression have bipolar depression, NeuroRx estimates that bipolar depression accounts for nearly half of all suicides each year.  Estimates indicate that 50% or more of individuals with bipolar disorder attempt suicide and that 11% or more succumb to suicide.

About NRX-101

NRX-101 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. In August 2017, NRX-101 was awarded FAST TRACK designation for treatment of Acute Suicidal Ideation and Behavior in patients with Bipolar Depression and has now entered a pivotal phase 2b/3 trial led by investigators from Harvard, Yale, Columbia, Baylor, and UAB.

Statistically significant results from two Phase II clinical studies, have been published in peer-reviewed journals. The studies showed a 50% reduction in symptoms of depression in patients with major depressive disorder and suicidal bipolar depression, and a 75% reduction in suicidal ideation in bipolar patients.  Biomarker studies using MR Spectroscopy have demonstrated beneficial changes in brain chemistry that equal the antidepressant effect of ketamine and exceed the neurochemical changes achieved with electroconvulsive therapy.

NeuroRx has now signed a Cooperative Research and Development Agreement with the US Dept. of Veterans Affairs to study the effects of NRX-101 in veterans with suicidal depression and PTSD.

About NeuroRx, Inc.

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. The company is privately- funded and led by former senior executives of Johnson and Johnson, Pfizer, Lilly, and Bristol Meyer Squibb.

Learn more at www.NeuroRxpharma.com.

SOURCE NeuroRx