N115 FDA Submissions

 

Until now the primary treatment for asthmatic bronchitis and chronic obstructive pulmonary diseases is the use of corticosteroids (67%). It is well documented that prolonged use of corticosteroids for the treatment of pulmonary diseases has serious side effects, including death. Other marketed drugs for the treatment of pulmonary diseases can produce central nervous system, cardiovascular, respiratory and gastrointestinal problems.

FDA Submissions: Clinical Findings for N115

  1. Rat Study: Effect of Intratracheal Injection of a Single Dose of Sodium pyruvate on the Lungs
  2. Rabbit Study: Effect of a Single Dose and Multiple Doses of Inhaled Sodium Pyruvate on the Lungs
  3. Rat Study: Effect of Multiple Intratracheal Administrations of Sodium Pyruvate on Lung Injury Caused by Bleomycin
  4. Rat Study: Multiple Dose Toxicity Study of Aerosolized Sodium Pyruvate in Sprague-Dawley Rats
  5. Rat Study: 180-Day Nose-Only Inhalation Study of Sodium Pyruvate in Charles River Rats
  6. Rat Study: Sodium Pyruvate: A 90 and 180 Day Nose-Only Inhalation Study in Rats (Study 2). Dosing at 10X the human therapeutic dose
  7.  Two-week Rabbit Inhalation Study - Safety of Repeated Dosing at Different Sodium Pyruvate Concentrations. Maximum tolerated dosing at 200X the human therapeutic dose 

Human  Clinical Studies

In all clinical studies, the inhalation of sodium pyruvate demonstrated clinically significant improvements in all lung functions parameters including FEV-1, PEF, SaO2 levels FEV-1/FVC ratios and clinically significant reductions in inflammatory cytokines, and hydrogen peroxide.  

1.     Inhaled Sodium Pyruvate for the Treatment of Bronchial Asthma/COPD, a Phase I/II Study.5 (John Votto, D.O., and Roger Thrall, Ph.D., Hospital for Special Care and the University of Connecticut Health Center) 

2.     Sodium Pyruvate/Nitric Oxide Pilot Study in Subjects with Lung Disease (John Votto, D.O., and Roger Thrall, Ph.D., Hospital for Special Care and the University of Connecticut Health Center) 

3.  Inhaled Sodium Pyruvate-SaO2 Pilot Study in Subjects with Lung Disease. Final Report for COPD Subjects (John Votto, M.D., Hospital for Special Care and the University of Connecticut) 

4.     Long-Term Use of Inhaled Sodium Pyruvate for the Treatment of Chronic Obstructive Pulmonary Disease. This was a two-center study. (John Votto, M.D., Hospital for Special Care and the University of Connecticut Health Center, and Roger S. Thrall, Ph.D. Hospital for Special Care, and Geoffrey Chupp, MD, Yale University School of Medicine, Yale New Haven Hospital, New Haven, Connecticut.13 

5.     Use of Inhaled Sodium Pyruvate for the Treatment of Subjects with Cystic Fibrosis (Carlos Milla, M.D. The Minnesota Cystic Fibrosis Center. University of Minnesota Medical School. Minneapolis, Minnesota 55455.)1415 , 

6.   Sodium Pyruvate Bronchodilation in Asthmatics (Donald Tashkin, M.D. David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA 90095)161718  

7.   A Phase 1 Pilot Study on the Effect of Inhaled Sodium Pyruvate in Subjects with Chronic Obstructive Pulmonary Disease. (A non-IND study) Francisco Flores Murrieta, MD, and Héctor Léon Molina, MD. Instituto Nacional de Enfermedades Respiratorios, Mexico City, Mexico 

8.     Open Label, Three-Week Study on the Effects of the Addition of Sodium Pyruvate Inhalation Therapy to Standard Treatment in Patients with Pulmonary Fibrosis. (Mario Hernandez, M.D., Manuel Lam, M.D., Omar Lopez, R.N. Nova Research Institute, Miami, Florida 33125) 

9.   Results of an Open Label Study on the Acute Effects of Three Days Administration of Sodium Pyruvate Nasal Spray Inhalation Drug on Patients with Pulmonary Fibrosis. (Mario Hernandez, M.D., Manuel Lam, M.D., Omar Lopez, R.N. Nova Research Institute, Miami, Florida 33125)

Sodium Pyruvate Nasal Spray Studies: Safety and Efficacy Data submitted to the FDA

Clinical Trial 1:  Twenty-four subjects.  All subjects completed the study, and none opted to return to their normal nasal spray therapy during this period. The data obtained from the rhinoscopic examinations indicated that the Sodium Pyruvate + Saline Nasal Spray did not induce dermal irritation and was effective in significantly (p=0.006) reducing the erythema in subjects who normally use either saline or non-saline nasal sprays like steroids,  when pre-test ratings were compared to post-test ratings.

Clinical Trial 2: Thirty-nine subjects who were regular nasal spray users due to chronic sinusitis or allergic rhinitis were recruited for this one-week open label, in home-use trial. Thirty-eight subjects completed the study. The data obtained from the rhinoscopic examinations indicated that Sodium Pyruvate + Saline Nasal Spray did not induce dermal irritation and was effective in reducing the erythema in subjects who normally use either saline or non-saline nasal sprays when pre-test ratings were compared to post-test ratings.

Clinical Trial 3: Fourteen-Day In-Use Evaluation of Nasal Sprays Containing Sodium Pyruvate and Reduced Steroids.  “Reduced-Strength Flonase®” and “Reduced-Strength Nasacort®” Test Product nasal sprays with sodium pyruvate  were found to be as effective as the “full-strength” (i.e. commercial) Flonase® and more effective than the commercial Nasacort® when the reduced commercial “active ingredients” were delivered to the subjects.

Clinical Trial 4: Fifty-three subjects. Treatment Effect of Sodium Pyruvate nasal saline spray on allergic Rhinitis. Randomized Placebo controlled study.  Results Sodium pyruvate nasal spray was effective in attenuating rhino conjunctivitis symptoms and reducing rescue medications use in allergic rhinitis patients. 

Clinical Trial 5: One hundred and thirty subjects. Blinded saline placebo controlled nasal spray study against a sodium pyruvate formulation in allergic Rhinitis patients.  Results: The sodium pyruvate formulation was clinically and statistically superior to saline in reducing nasal inflammation and congestion.

Clinical Trial 6:  Sixty subjects. Random and positive controlled clinical trial to evaluate the efficacy and safety of the sodium pyruvate nasal spray in the treatment of Chronic Rhinitis (allergic and non-allergic) Results: The use of a Sodium pyruvate nasal spray was safe and effective and clinically superior to saline in reducing nasal symptoms in these patients.

Clinical study 7: Seventy-seven subjects. Research on the efficacy of sodium pyruvate nasal spray to treat mild to moderate Allergic Rhinitis. Results: Sodium pyruvate nasal spray, as a non-drug treatment, can effectively improve the symptoms of mild to moderate AR.

Clinical Trial 8:  Human Mucociliary clearance time (MCT) studies.  Several studies have shown the effect of nasal saline on MCT. Our investigators have found isotonic saline sped clearance time by 2%, while the Sodium pyruvate nasal formula sped clearance by 17% 10-20 minutes after treatment in 32 adults.

Summary

In all patients tested, (92%) of these patients stated that the Pyruvate Saline Nasal Spray opened their nasal passages and cleared their congestion for over 12 hours. In each study the Sodium Pyruvate Saline Nasal Sprays were objectively and subjectively judged to be “Comparable To” or “Better Than” both Saline or Steroid-based commercial nasal sprays. To date millions of Patients have inhaled Sodium Pyruvate with no adverse events reported. 

Evaluation of the Sodium Pyruvate Formulation to Deliver Other Drugs

Nicotine Inhalation with Pyruvate in the Sinuses or Lungs.We placed nicotine into a modified pyruvate nasal solution and discovered that inhaled nicotine (nasal or lungs) was well tolerated over nicotine by itself, which was irritating. The combination was synergistic. Forty Smokers who used this formula rated the pyruvate nicotine formula much higher than nicotine by itself.  The 20mM pyruvate solution in combination with nicotine balanced the negative effect of nicotine and enhanced the effect of nicotine.

Insulin inhalation with Pyruvate in the Sinuses or Lungs. The addition of pyruvate enhanced insulin uptake for patients that have diabetes with pulmonary lung or sinus diseases.  The 20mM pyruvate solution in combination with insulin balanced the negative effect of insulin and enhanced the effect of insulin. 

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