New Treatment for Pulmonary Fibrosis - Submission of Medical Endpoints to the FDA

EmphyCorp Press Release

New Treatment for Pulmonary Fibrosis to improve Patient Quality of Life

EmphyCorp is proud to announce the completion of two clinical trials with our nasal spray, to define medical endpoints as requested by the FDA for the NDA marketing application in patients with pulmonary Fibrosis, under its Orphan Drug Designations for the treatment of Interstitial Lung Diseases (ILD), which includes Pulmonary Fibrosis and Cystic Fibrosis. 

The Clinical trials with our nasal spray, demonstrated a statistically and clinically significant increase FEV-1, SaO2, FVC, FEV-1/FVC ratios (52% to 86%), and  nitric oxide, (needed to increase bronchial dilation and fight infections), and a significant reduction of coughing, nasal erythema, inflammation and congestion, in all patients tested with  Idiopathic pulmonary fibrosis. 

Interstitial lung diseases, encompass a large group of chronic lung disorders, including Pulmonary Fibrosis, associated with excessive tissue remodeling, scarring, fibrosis, decreased FEV-1/FVC ratios, decreases in nasal nitric oxide, and a decrease in total lung capacity. 96.88% of Pulmonary Fibrosis patients have congestion caused by nasal inflammation by age 60, which decreases the ability of nasal nitric oxide to maintain normal lung functions leading to increased lung and nasal infections, a reduced SaO2 level, post nasal drip that causes coughing, mouth breathing, and reduced FVC levels.  

Nasal steroids and other OTC nasal treatments shut down the synthesis of nasal nitric oxide, which leads to decreased lung function and a 34% increase in infections. 

There have been over 32,381 patient complaints to the FDA from patients with Idiopathic Pulmonary Fibrosis, stating that Rx, OTC, and steroid-based inhalation products, have failed to provide relief from nasal or lung inflammation2. (Data from FDA reports and the FDA Voice of the Patient publication).

EmphyCorp globally patented nasal delivery system, with sodium pyruvate which is a naturally occurring antioxidant of the human body, has been shown to significantly reduce inflammatory agents throughout the human body, including the lungs as demonstrated in eight Phase I/II and partial phase III human studies and eight human nasal studies submitted to the FDA in patients with, COPD, Pulmonary Fibrosis, and Cystic Fibrosis (CF) patients for our NDA submission.

Over one and a half million nasal spray units have been used to treat patients in over 100 hospitals, including an estimated 150,000 patients with COPD, and patients with Unmet Needs, which  includes Pregnant Women, small children, diabetics, and hypertensive who suffer from nasal congestion, nasal drip, Inflammation, but cannot take any nasal sprays with steroids. The “Unmet Needs” patients represent 30 to 60 Million patients in America alone, without a nasal spray they can use. In some cases, not having a nasal spray product can be life threatening. In China we have treated over 60,000 Pregnant Women, thousands of newborn children, and thousands of diabetic and hypertensive patients, while demonstrating both safety and efficacy, with no adverse events reported.

EmphyCorp Inc. is a privately funded pharmaceutical-based, drug discovery company that is currently engaged in the discovery, development and commercialization of new Non-Steroidal remedies for pulmonary and respiratory conditions. The company  directly  targets medical conditions that degrade a patient's quality of life, such as allergic rhinitis, asthma, cystic fibrosis, interstitial lung, chronic obstructive pulmonary disease, cancer, Alzheimer’s, and smoking. 

For more information:

Please contact Robert Millar, Director at 973-586-4421

Or Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

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