Medical

Theravance Biopharma and Mylan have announced that a 12-month Phase 3 safety study of nebulized revefenacin (TD-4208) showed that the drug was well tolerated, with low rates of adverse events and serious adverse events that were comparable to a standard of care treatment arm. The 52-week safety study compared 2 doses of revefenacin to tiotropium. Half of the … [Read more...] about Positive results from Phase 3 safety study of nebulized revefenacin

Samumed has announced positive results from a Phase I trial of an inhalation solution of its novel Wnt signaling modulator SM04646, which the company is developing for the treatment of idiopathic pulmonary fibrosis (IPF). The study enrolled 17 healthy subjects and delivered 4 ascending doses of SM04646 in a single inhalation via nebulizer. All doses were well … [Read more...] about Positive Phase 1 results for Samumed’s inhaled Wnt signaling modulator

Savara Pharmaceuticals has presented interim results from a Phase 2 study of Aironite sodium nitrite inhalation solution for the treatment of pulmonary hypertension at the 4th Annual Drug Discovery and Development Symposium for Pulmonary Hypertension. Savara acquired Aironite when Mast Therapeutics merged with the company earlier this year. Mast had acquired … [Read more...] about Positive interim results from Phase 2 study of Aironite for pulmonary hypertension

Windtree Therapeutics has announced that its Phase 2b clinical trial of Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants receiving nasal continuous positive airway pressure (nCPAP) failed to meet its primary endpoint, reduction in nCPAP failure at 72 hours. The study enrolled 221 infants that received … [Read more...] about Phase 2b trial of Aerosurf inhaled surfactant for RDS fails to meet primary endpoint

The AIR Louisville program, which distributed Propeller Health's inhaler monitoring technology to asthma and COPD patients in Louisville, Kentucky, has announced its final results. Beginning in 2015, the program enrolled 1,147 patients and captured data on over 250,000 inhaler puffs. According to AIR Louisville, participants using the Propeller reduced their use of … [Read more...] about AIR Louisville results show 82% reduction in rescue inhaler use

Sun Pharma Advanced Research Company Ltd. (SPARC) has announced that its SPARC DPI salmeterol 25 µg/fluticasone propionate 50 µg dry powder inhaler failed to show bioequivalence to Seretide Accuhaler (Advair Diskus) salmeterol 50 µg/fluticasone propionate 100 µg in a pivotal study because the peak concentration of salmeterol for patients using the SPARC DPI was higher … [Read more...] about SPARC announces top line results of pivotal trial of SPARC DPI, a generic version of Seretide Accuhaler/Advair Diskus

German biotech Ventaleon, a spin-off of Activaero, which was acquired by Vectura in 2014, presented data from a Phase 2 trial of inhaled D, L-lysine acetylsalicylate glycine (LASAG) in severe influenza at the recent ISAM Congress that show inhibition of a signaling factor required for flu virus replication. The double-blind placebo-controlled study, in 41 … [Read more...] about Ventaleon presents data from Phase 2 study of inhaled LASAG for severe influenza

Dr. Reddy's subsidiary Promius Pharma has announced that a Phase 2 study of its DFN-02 intranasal sumatriptan for the treatment of migraine met its primary endpoint, the proportion of subjects free of migraine pain at 2 hours post dose. After 2 hours, 43.8% of patients treated with DFN-02 experienced migraine pain relief compared to 22.5% of patients who received … [Read more...] about Phase 2 study of Promius Pharma’s intranasal sumatriptan meets primary endpoint