New Non-Steroidal Treatment for Lung Diseases to Improve Patient Quality of Life
The Centers for Disease Control and Prevention (CDC) estimates there are 30 million plus Americans with COPD and an additional 30 to 60 Million patients in America alone called “Unmet Needs” patients which cannot use steroids and thus are without a safe nasal or inhalation spray they can use.
In some cases, not having an oral inhalation or nasal spray product can be life threatening. The Unmet Needs group represents Pregnant Women, thousands of newborn children, and millions of diabetic and hypertensive patients, including patients with pulmonary fibrosis.
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).
In addition to the U.S. market, there is a significant worldwide need for an effective non-toxic, non-steroid pulmonary disease drug. The combined populations of Europe, Japan, Canada and the United States equal 1.135 billion people. Of this population group, 5%, or 56.75 million people suffer from COPD and related lung diseases.
EmphyCorp globally patented nasal and oral 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 and nasal cavity and produced statistically and clinically significant increases in lung function measurements, including FEV-1, FVC, PEF, SaO2, and FEV-1/FVC ratios, Nitric oxide and reduced nasal and lung inflammation. 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. No adverse events were reported.
EmphyCorp has the proprietary technology to penetrate this market and secure a major market share. EmphyCorp will target the U.S. market first and then the worldwide markets by entering into Sublicense Agreements and/or Joint Venture or outright sale with respiratory drug manufacturers or companies seeking to enter the respiratory drug market, both in the U.S. and foreign countries.