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New Antidepressant NRX-1074 (NMDA Receptor Modulator) In Development

NRX-1074 is a new antidepressant under development by the biotech company Naurex. It is this same company that has already been granted “fast track” status by the FDA for their intravenous antidepressant GLYX-13 – which shows significant promise. Naurex’s private stock has been steadily rising due to emergence of preliminary evidence suggesting that both of these drugs have significant advantages over current antidepressant options.

What is NRX-1074?

This is considered a second-generation antidepressant compound that acts as a selective partial NDMA receptor agonist, specifically at the glycine site. In other words, it works very similar to the drug GLYX-13 which is also under development by the same company. Although NRX-1074 is not as far through clinical trials as GLYX-13, it should be mentioned that some evidence suggests that it may actually be superior in efficacy to GLYX-13 due to the fact that it is more potent by weight.

Both of these drugs are essentially eliciting similar antidepressant effects to the illicit drug ketamine.  It has long been known that ketamine works for depression.  However, ketamine also tends to elicit unwanted adverse effects, particularly those that are of psychomimetic nature.  Therefore many drug companies have sought out how to isolate the antidepressant properties of ketamine, while eliminating the cause of the unwanted “trippy” effects.

Initially the drug Lanicemine (AZD6765) was in development by AstraZeneca, but it never made it through clinical trials.  Naurex seems to have cracked the code with their latest developments by finding a way to create effective drugs without the unwanted side effects.  Since the drug NRX-1074 is relatively similar to an existing development by Naurex, below is a brief comparative analysis.

Drug Comparison: NRX-1074 vs. GLYX-13

There are several key differences between NRX-1074 and GLYX-13. Although GLYX-13 is likely to be approved by the FDA before NRX-1074, it doesn’t necessarily mean its better. In fact, there is significant evidence to suggest that this medication would be preferred over GLYX-13 for numerous reasons. Below is a brief comparison of the drugs given current information available to the general public.

  • Administration: Currently GLYX-13 is only available as an intravenous injection whereas NRX-1074 is available to take orally (i.e. pill form).
  • Antidepressant: Both drugs show promising antidepressant potential. However, the drug GLYX-13 is indicated as being used as an antidepressant augmentation strategy, whereas NRX-1074 is being touted as a standalone treatment option. Both seem to elicit similar “rapid onset” antidepressant effects as a result of their similar mechanism of action.
  • Mechanism of action: Both drugs have similar mechanisms of action, affecting the NMDA receptor’s glycine site as selective partial agonists.
  • Potency: NRX-1074 is considered to be “several thousand” times more potent by weight in comparison to GLYX-13. This does not mean that it is going to be several thousand times “more effective” – rather it means that the drug is more potent based on its weight.
  • Tolerability: Both substances seem to be very tolerable based on data collected from early clinical trials. Adverse effects seem to be relatively uncommon as do major unwanted side effects. With that said, further data will be unveiled as they continue to advance through clinical trials and we will get a better understanding of the tolerability.

NRX-1074: Clinical Trials

As of May 2014, this substance was in Phase II(A) clinical trials for major depression. It has since advanced to Phase II(B) trials and therefore is slightly behind in development compared to GLYX-13. With that said, GLYX-13 has received “fast track” status from the FDA as an adjunctive treatment strategy, whereas NRX-1074 has not been granted this status.

It could eventually be “fast tracked” if the treatment shows significant promise with minimal safety concerns. Many would argue that since its “relative” (GLYX-13) has received this “fast tracking” that NRX-1074 should be granted the same – after all, they are very similar in terms of general function and neither seem to elicit psychomimetic effects.

Given the current developments by the company Naurex, it seems as though we will soon have a new classification of antidepressant drugs available. These may be classified as “NMDA receptor modulators” or something along those lines. It is unclear as to whether the NRX-1074 is merely an attempt of making an oral formulation of GLYX-13 or whether a separate oral formulation of GLYX-13 will become available.

Final Thoughts on NRX-1074

There seems to be significant promise of NRX-1074 in early stages of studies. Although it isn’t guaranteed that this drug will pass clinical trials and become available to the public, at this stage it seems very likely that it will eventually be granted FDA approval. It is good to see companies like Naurex branching out into an entirely new direction (away from the highly outdated “serotonin hypothesis”) for the treatment of depression.

This may spur a variety of other companies to create other partial NMDA receptor agonists, but this will likely result in improvements to the early drugs in this class. It can only be hoped that companies continue to think “outside the box” in regards to treatment for depression and other mental health conditions. Drugs like NRX-1074 and even ALKS 5461 treat depression by targeting neurotransmitters other than the common: serotonin and norepinephrine.

It is unlikely that this will become a “utopian” treatment option, but early evidence suggest that the development of this medication is much-needed for those who don’t benefit from existing medications. No “drug” will ever offer a cure for depression, but some drugs may be more universally effective and may work for longer periods of time (before tolerance is established) with less adverse effects compared to current-market drugs. As of now we can only wait and hope there are no major hang-ups with clinical trials.

  • Source: https://clinicaltrials.gov/ct2/show/NCT02067793

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{ 1 comment… add one }
  • Cindy February 19, 2016, 3:42 am

    I now have hope. I’ve been depressed for 4 years and am now on so many pills I don’t know what I am doing.

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