Interstitial Lung Disease – Pulmonary Fibrosis Treatment & Idiopathic Pulmonary Fibrosis Coughing and Improved Lung Function Treatments (Patented Rx Technology)
- Rx N115 Nonsteroidal Nasal Spray treats up to (8) medical endpoints with the use of a single nasal spray
- In a completed Phase III, 21 day Clinical Trial with Rx N115, a Nonsteroidal Nasal Spray, in Patients with Pulmonary Fibrosis, there was a statistically and clinically significant improvement in all lung functions, compared to placebo and baseline measurements, including the measurements for FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%) and a decrease in hypoxemia, along with a reduction in coughing and fatigue. No adverse events were reported.
- In a completed Pivotal Phase III Double Blinded Placebo controlled Clinical Trial for the FDA New Drug Application (NDA), patients with Idiopathic Pulmonary Fibrosis (IPF) were treated for 21 days with the Rx N115 a Nonsteroidal Nasal Spray and demonstrated a statistically and clinically significant improvement in Coughing (73% reduction in all patients with Uncontrolled Coughing. All patients reported being able to sleep at night), with a statistically and clinically significant improvement in Lung Functions including FEV-1, SaO2, FVC, FEV-1/FVC ratios. No adverse events were reported.
- Ready to submit an FDA Marketing Application as part of the New Drug Application for IPF Coughing and Improved Lung Function with the clinical results listed above. The Marketing Application requires a manufacturing site, a drug master manufacturing file, and the marketing and distribution of Rx N115 Nonsteroidal Nasal Spray for IPF Coughing and Improved Lung Function treatment to US Pharmacies. Actively seeking a pharmaceutical partner for completing and submitting the marketing application to the FDA.