FDA Submissions

Sodium Pyruvate is biochemically classified as an α-ketoacid and is part of the body’s natural endogenous antioxidant defense system. It is secreted by cells, readily enters cells, and can directly react to detoxify detrimental compounds such as H2O2 and peroxynitrites. Sodium Pyruvate has been shown to significantly reduce inflammatory agents in all parts of the human body including the lungs and the nasal cavities. The inflammatory agents being reduced include hydrogen peroxide, nitric oxide, IL-8, TNF, and other inflammatory cytokines, that are produced by oxygen radicals.

Normal plasma levels of Sodium Pyruvate are approximately 0.1 mM and normal intracellular levels can reach 0.5 mM. Sodium pyruvate has been shown to have protective antioxidant activity both in vitro and in vivo. There are four major chemical pathways by which sodium pyruvate can either directly or indirectly generate or augment an antioxidant or anti-inflammatory effect:

1. Hydrogen peroxide. H2O2 is directly toxic to cells and also is a precursor to other reactive oxygen species. Inhibition of H2O2 would have broad antioxidant and anti-inflammatory effects. Sodium pyruvate directly interacts non-enzymatically with H2O2 to generate the non-toxic compounds CO2 and H2O.

1. Peroxynitrites. Compounds referred to as peroxynitrites are produced in the reaction of superoxide anion with NO. The peroxynitrites are known to be more toxic and more active than either superoxide anion or NO alone. They are very toxic and disruptive to cell membranes via lipid peroxidation not only leading to cell death but also dysfunction of many cellular membrane functions, such as transport mechanisms. Sodium Pyruvate directly interacts in a 2nd order chemical reaction with peroxynitrites converting them into non-toxic compounds.

1. NADPH2. An essential component in the reductive activity of thiol compounds like GSH is the generation of NADPH2, which aids in driving the reaction to the reduced state (i.e., GSH), thus replenishing antioxidant activity. Sodium Pyruvate has been shown to play an important role in the generation of intracellular NADPH2 and therefore may help in maintaining optimal levels of thiol compounds, such as GSH.

1. Reduction of inflammatory Cytokines. Sodium Pyruvate has been shown to reduce many inflammatory cytokines like Il-6, IL-8 TNF etc. In our own studies with CF patients, EmphyCorp showed a significant reduction of these cytokines in CF patients treated with0.5mM Pyruvate.

Clinically, Sodium Pyruvate has been given to patients for a variety of disorders ranging from Friedreich’s ataxia to open heart operations and including kidney surgery, eye surgery, hyperkeratotic disorders, and treatment of mitochondrial diseases.

It has been administered via several routes including intravenous (10-20 times EmphyCorp’s inhaled therapeutic dose), topical administration for hyperkeratotic disorders (61), and in dietary supplementation. Sodium pyruvate has been shown to protect neurons, lungs, hearts, muscles, cerebral metabolism, embryos, eyes, kidneys, cellular DNA and membranes from oxygen radical damage.

The levels of Sodium Pyruvate employed in these applications are 2-32mM concentrations. In human and animal studies, Sodium Pyruvate was shown to facilitate wound healing, decrease inflammation, and decrease production of oxygen radicals. It is being sold as an OTC product and is being used in the gastrointestinal tract to heal surgical wounds. Sodium Pyruvate or the other a- keto acids are considered “Generally Regarded as Safe” (GRAS) by the FDA

In summary, Sodium Pyruvate is a safe and efficacious antagonist of both reactive oxygen and nitrogen species. It also has the potential to increase intracellular levels of thiol compounds, major sources of intracellular anti-oxidants. Sodium Pyruvate has been shown to act as an anti-inflammatory agent that can reduce the number of infiltrating neutrophils and levels of oxygen radicals at wound sites, thereby limiting the production of pro-inflammatory mediators.

SODIUM PYRUVATE:

SAFETY

EmphyCorp, Inc. has discovered and patented the use of Sodium Pyruvate as an inhaled natural antioxidant that significantly reduces inflammatory agents throughout the human body including the lungs and nasal cavities. The lung and sinus inflammatory agents that are reduced include oxygen radicals like hydrogen peroxide, and inflammatory cytokines including Interleukin 6 (IL-6). 

Sodium Pyruvate increases nasal nitric oxide needed to kill infections to safely treat sinus infections and symptoms in numerous lung diseases including COVID-19, long COVID and Flu. It acts like a steroid, but is non-toxic, safe and natural. 

As demonstrated in 19 Human FDA Clinicals with thousands of Patients, our Drug Patented N115 Nasal Spray with Sodium Pyruvate was shown to increase all lung functions, SaO2, while also decreasing coughing, hypoxemia and dyspnea.

Pyruvate is a natural antioxidant component of human cells that is critical to human survival. Sodium Pyruvate provides energy to all human cells. 

Sodium Pyruvate has been studied for over 100 years with over 33,000 publications in peer review journals, providing ample data as to its safety and mechanism of actions. Sodium Pyruvate is used in OTC Nasal Products as an antioxidant.

As with many products that contain Sodium Pyruvate (Neosporin, Lubriderm, Vaginal Products, Viva Eye Drops, Ringers Solution, Human IV Solutions, and solutions to store red blood cells by the Red Cross and store human organs for transplant), its main function is as an antioxidant and anti-inflammatory agent. 

Sodium Pyruvate is considered GRAS (Generally Regarded as safe) by the FDA and it has been administered to patients for a variety of medical disorders by oral, intravenous, or topical administration and applications including: the treatment of Friedreich’s ataxia, as a constituent in a therapeutic solution used in open heart surgery,  kidney surgery, eye surgery, mitochondrial diseases, as an oral dietary supplement, and as a component in organ transplant media that is being used to preserve human lungs, hearts, and other organs for human transplants.  

In summary the use of our N115 Nasal Spray with inhaled Sodium Pyruvate has been shown to be safe and efficacious in the treatment of Patients with Covid-19 infections, COVID long haulers, Flu, COPD, Asthma, Cystic Fibrosis, Pulmonary Fibrosis, Allergic Rhinitis, and Patients suffering with Hypoxemia. 

Sodium Pyruvate is biochemically classified as an α-ketoacid and is part of the body’s natural endogenous antioxidant defense system. It is secreted by cells, readily enters cells, and can directly react to detoxify detrimental compounds such as H2O2 and peroxynitrites. Sodium Pyruvate has been shown to significantly reduce inflammatory agents in all parts of the human body including the lungs and the nasal cavities. The inflammatory agents being reduced include hydrogen peroxide, nitric oxide, IL-8, TNF, and other inflammatory cytokines, that are produced by oxygen radicals.

Normal plasma levels of Sodium Pyruvate are approximately 0.1 mM and normal intracellular levels can reach 0.5 mM. Sodium pyruvate has been shown to have protective antioxidant activity both in vitro and in vivo. There are four major chemical pathways by which sodium pyruvate can either directly or indirectly generate or augment an antioxidant or anti-inflammatory effect:

1. Hydrogen peroxide. H2O2 is directly toxic to cells and also is a precursor to other reactive oxygen species. Inhibition of H2O2 would have broad antioxidant and anti-inflammatory effects. Sodium pyruvate directly interacts non-enzymatically with H2O2 to generate the non-toxic compounds CO2 and H2O.
2. Peroxynitrites. Compounds referred to as peroxynitrites are produced in the reaction of superoxide anion with NO. The peroxynitrites are known to be more toxic and more active than either superoxide anion or NO alone. They are very toxic and disruptive to cell membranes via lipid peroxidation not only leading to cell death but also dysfunction of many cellular membrane functions, such as transport mechanisms. Sodium Pyruvate directly interacts in a 2nd order chemical reaction with peroxynitrites converting them into non-toxic compounds.
3. NADPH2. An essential component in the reductive activity of thiol compounds like GSH is the generation of NADPH2, which aids in driving the reaction to the reduced state (i.e., GSH), thus replenishing antioxidant activity. Sodium Pyruvate has been shown to play an important role in the generation of intracellular NADPH2 and therefore may help in maintaining optimal levels of thiol compounds, such as GSH.
4. Reduction of inflammatory Cytokines. Sodium Pyruvate has been shown to reduce many inflammatory cytokines like Il-6, IL-8 TNF etc. In our own studies with CF patients, EmphyCorp showed a significant reduction of these cytokines in CF patients treated with0.5mM Pyruvate.

Clinically, Sodium Pyruvate has been given to patients for a variety of disorders ranging from Friedreich’s ataxia to open heart operations and including kidney surgery, eye surgery, hyperkeratotic disorders, and treatment of mitochondrial diseases.

It has been administered via several routes including intravenous (10-20 times EmphyCorp’s inhaled therapeutic dose), topical administration for hyperkeratotic disorders (61), and in dietary supplementation. Sodium pyruvate has been shown to protect neurons, lungs, hearts, muscles, cerebral metabolism, embryos, eyes, kidneys, cellular DNA and membranes from oxygen radical damage.

The levels of Sodium Pyruvate employed in these applications are 2-32mM concentrations. In human and animal studies, Sodium Pyruvate was shown to facilitate wound healing, decrease inflammation, and decrease production of oxygen radicals. It is being sold as an OTC product and is being used in the gastrointestinal tract to heal surgical wounds. Sodium Pyruvate or the other a- keto acids are considered “Generally Regarded as Safe” (GRAS) by the FDA

In summary, Sodium Pyruvate is a safe and efficacious antagonist of both reactive oxygen and nitrogen species. It also has the potential to increase intracellular levels of thiol compounds, major sources of intracellular anti-oxidants. Sodium Pyruvate has been shown to act as an anti-inflammatory agent that can reduce the number of infiltrating neutrophils and levels of oxygen radicals at wound sites, thereby limiting the production of pro-inflammatory mediators.

SODIUM PYRUVATE:

SAFETY

EmphyCorp, Inc. has discovered and patented the use of Sodium Pyruvate as an inhaled natural antioxidant that significantly reduces inflammatory agents throughout the human body including the lungs and nasal cavities. The lung and sinus inflammatory agents that are reduced include oxygen radicals like hydrogen peroxide, and inflammatory cytokines including Interleukin 6 (IL-6). 

Sodium Pyruvate increases nasal nitric oxide needed to kill infections to safely treat sinus infections and symptoms in numerous lung diseases including COVID-19, long COVID and Flu. It acts like a steroid, but is non-toxic, safe and natural. 

As demonstrated in 19 Human FDA Clinicals with thousands of Patients, our Drug Patented N115 Nasal Spray with Sodium Pyruvate was shown to increase all lung functions, SaO2, while also decreasing coughing, hypoxemia and dyspnea.

Pyruvate is a natural antioxidant component of human cells that is critical to human survival. Sodium Pyruvate provides energy to all human cells. 

Sodium Pyruvate has been studied for over 100 years with over 33,000 publications in peer review journals, providing ample data as to its safety and mechanism of actions. Sodium Pyruvate is used in OTC Nasal Products as an antioxidant.

As with many products that contain Sodium Pyruvate (Neosporin, Lubriderm, Vaginal Products, Viva Eye Drops, Ringers Solution, Human IV Solutions, and solutions to store red blood cells by the Red Cross and store human organs for transplant), its main function is as an antioxidant and anti-inflammatory agent. 

Sodium Pyruvate is considered GRAS (Generally Regarded as safe) by the FDA and it has been administered to patients for a variety of medical disorders by oral, intravenous, or topical administration and applications including: the treatment of Friedreich’s ataxia, as a constituent in a therapeutic solution used in open heart surgery,  kidney surgery, eye surgery, mitochondrial diseases, as an oral dietary supplement, and as a component in organ transplant media that is being used to preserve human lungs, hearts, and other organs for human transplants.  

In summary the use of our N115 Nasal Spray with inhaled Sodium Pyruvate has been shown to be safe and efficacious in the treatment of Patients with Covid-19 infections, COVID long haulers, Flu, COPD, Asthma, Cystic Fibrosis, Pulmonary Fibrosis, Allergic Rhinitis, and Patients suffering with Hypoxemia. 

Effect of Inhaled Sodium Pyruvate on Regulating Nitric Oxide (NO) in Inflammatory Lung Disease

Nitric oxide (NO) produces clinically useful bronchodilation (1) and is also used by the body to kill bacteria, fungal infections, viral infections, and tumors. The pharmaceutical industry is answering the challenge of the link between inflammation and lung diseases by developing and launching a number of antiinflammatory compounds designed to reduce and manage lung inflammation, or to “up regulate” components of the inflammatory process like NO to fight lung infections and tumors. The currently FDA recognized primary markers for lung disease include oxygen radicals (hydrogen peroxide), NO, histamines, leukotrienes, prostaglandins, pro-inflammatory cytokines, interleukins and chemokines. The two major antiinflammatory agents used to treat lung inflammation are the corticosteriods and anti-leukotrienes. The corticosteriods reduce lung inflammation by preventing the activation and migration of inflammatory cells into the lungs. The ability of inhaled steroids to reduce lung inflammation can be measured by the decreased levels of the above mentioned inflammatory markers. The problem is that not all patients’ respond, and corticosteriods can have serious toxic side effects. The anti-leukotrienes work by inhibiting the synthesis of leukotrienes and include the products Singulair,Accolate, and Zyflo. Again their efficacy is limited to about 50% of patients treated, and they do not significantly improve FEV1* values. The ability to up regulate the synthesis of NO is also being developed by many companies that are developing the use of arginine or arginine analogs to fight lung infections and cancers. The problem with inhaled arginine or arginine analogs has been their toxicity.

Thus, the ability of inhaled pyruvate to “up regulate” or down regulate NO levels in lungs and to protect NO from other oxygen radicals, allows NO to deactivate NF-kappa B, which, in turn,will reduce lung NO levels and reduce lung inflammation. In human clinical studies, sodium pyruvate at lower concentrations decreased hydrogen peroxide and NO levels in patients treated by inhalation therapy. Sodium pyruvate inhalation at higher concentrations increased NO levels in expired breaths, of asthmatics and moderate and severe COPD patients, that could be used to treat lung cancers, lung infections, especially in patients with cystic fibrosis. Patients with cystic fibrosis, produce very low levels of NO, that allows viral replication to occur. In HSV-1 infected cells, sodium pyruvate at the higher concentrations, reduced viral loads and in combination with antiviral agents, eliminated the virus completely from the infected cells.

The FDA has determined that N115 has sufficient safety toxicology and clinical data to proceed with the multi-dose, extended use, clinical trials. Phase III/Phase IV studies will focus on Pulmonary Fibrosis, Unmet Needs and COPD patients. On the basis of existing clinical data, EmphyCorp is confident that its Investigative New Drug, N115, can and will be used for maintenance or continuous treatment of patients over extended periods of time. The Company believes that N115 will set the standard in the pharmaceutical industry for the treatment of major pulmonary diseases.