Posted on December 12th, 2016
by Robert Besthof
This past week the NMDA field continued to narrow itself with the unfortunate recent failure of Cerecor’s CERC-301 for major depressive disorder. As someone who has spent a lengthy career in neuroscience cheering on the progress of all firms, this is particularly disappointing. The psychiatry field desperately needs successes. Few companies remain in the field, or like most big pharma, no longer see it as a priority. Those companies that are pursuing the area of depression, such as Cerecor, J&J, Allergan, and us at NeuroRx, have mostly clustered around the NMDA mechanism.
Patients need new drugs for depression and suicidal ideation, and treatments that work much sooner and provide higher levels of response. To date, there is no medicine indicated for suicidal ideation (thoughts or behaviors of suicide), which is establishing itself as a separate indication from depression.
Ketamine is a full NMDA blocker that has shown a strong and rapid reduction in both depression and suicidal ideation in clinical trials, including data by Dr. Carlos Zarate at NIH, in Treatment Resistant Bipolar Depression. However, there are significant strategic challenges around NMDA receptor based drugs; some are specific to the NMDA mechanism, while others are “par for the course” in psychiatry studies:
Given these hurdles, what is the best approach to mitigate the challenges associated with the development of a new NMDA based treatment? Here is our thinking at NeuroRx, as reflected on our upcoming study for NRX-101:
In the USA approximately 43,000 lives are lost to suicide every year. We estimate that more than half of those could be due to ASIBD. Members of our leadership team have felt the impact of this disease personally, and understand the urgent need for a new effective treatment. We remain committed to the development of NRX-101.
As we progress NRX-101 into a Phase 2b/3 clinical study, let me wish all of us still in the field the very best…patients are urgently waiting.
This blog was originally published at https://www.linkedin.com/pulse/race-next-antidepressant-challenges-tribulations-nmda-besthof
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