JPS Health Network has joined with pharmaceutical company NeuroRX to conduct clinical trials of a drug program that has the potential to greatly reduce the number suicides among people struggling with bipolar disorder.
According to Dr. Cynthia Claassen, Director of Research and Education at the health network, the work is groundbreaking because there is currently no indicated drug therapy specifically for people with bipolar depression including suicidal inclinations. Suicide has become a nationwide problem, and the Dallas-Fort Worth area is no exception.
"The suicide rate in Tarrant County has increased 35 percent faster than the population over the past 20 years. This means that JPS patients are increasingly vulnerable to suicidal acts," Claassen said. “We need to be doing whatever we can to be a part of the solution to this problem.”
About 50 percent of bipolar patients will attempt suicide at some point, while more than 100 people across the United States succeed in ending their life each day, according to the American Foundation for Suicide Prevention. Suicide is the 10th-highest cause of death in this country. Last year, JPS treated 524 bi-polar patients who were considered to be a suicide risk.
For the past several months, JPS has been working to plan its clinical trial with NeuroRx and the U.S. Food and Drug Administration (FDA) in hopes of gaining approval for the treatments, called NRX-101. The trials are now underway with hopes of gaining final government approval by the end of next summer.
"We need to be doing whatever we can to be a part of the solution to this problem."
The NRX-101 treatments consist of an oral medication patients can take at home, making it easier for them to stay on their medication and avoid relapsing into a suicidal state.
"To our knowledge, this is the first well-controlled study in which patients with severe bipolar depression and acute suicidal ideation have been maintained in remission with an oral drug regimen," said Dr. Fred Grossman NeuroRx's Chief Medical Officer. "This is a population of patients who frequently require prolonged hospitalization and electroshock therapy and who have a 20 percent chance of dying from suicide at some point."
Because of the encouraging results of testing so far, the FDA has granted NRX-101 its “breakthrough therapy designation.” That’s a process designed to expedite the development and review of drugs that are intended to treat a serious condition when there is preliminary clinical evidence that indicates the drug may demonstrate substantial improvement over available therapy.
In May, NeuroRX reported “significant final results” from a multicenter study on the effectiveness of NRX-101. The study was in partnership with Harvard University and Massachusetts General Hospital, The University of Alabama-Birmingham and the Baylor College of Medicine. The study found patients who received NRX-101 following a single dose of ketamine had considerably lower levels of depression on the Montgomery Asberg Depression Rating Scale (MADRS) than those in the control group.
Studies have additionally found that NRX-101 is well tolerated without hallucinations and other dissociative side effects, Grossman reported.
NeuroRX leaders said they were interested in JPS as a site for the clinical trials because they wanted to work with a healthcare organization that has a close and familiar relationship with its bipolar patients. It’s important, they said, to have a high confidence level in patients’ response to the treatments.
Claassen said she is excited JPS is part of the process of testing NRX-101 because financially disadvantaged people often aren’t asked to participate in similar trials – even when the product on trial stands to benefit them immensely.
“As a general rule, under-served populations like the JPS patient population are not well represented in clinical trial research for several reasons,” Claassen said. “These patients are often more compromised medically, often have more severe forms of illness, and frequently have less access to basic resources like transportation to attend medical appointments... So, when new treatments come along, they have been evaluated under conditions that do not apply to populations like ours. Yet it is our patients who really need the most help. Conducting clinical trial research in the ‘real world’ -- at sites like JPS -- is the only way to ensure that our patients benefit from new treatment approaches which advance care and improve the quality of their lives.”