Theravance Biopharma and Mylan announced that they have initiated Phase 3 studies for TD-4208 revefenacin inhalation solution for the treatment of COPD. The Phase 3 program includes 2 12-week efficacy studies plus a 12-month safety study and is expected to enroll 2,300 patients. The two companies announced in February 2015 that they would partner on development of the … [Read more...] about Mylan and Theravance Biopharma initiate Phase 3 trials of revefenacin for COPD
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AZTherapies begins Phase 3 study of inhaled Alzheimers therapy
AZTherapies announced that it has initiated a Phase 3 study of its ALZT-OP1 DPI for the treatment of early stage Alzheimer's disease. ALZT-OP1 is a dry powder formulation of cromolyn and ibuprofen that is delivered by a proprietary inhaler called Azhaler-D; AZTherapies licensed the technology from Massachusetts General Hospital. The company said that it plans to be … [Read more...] about AZTherapies begins Phase 3 study of inhaled Alzheimers therapy
KAER Biotherapeutics gets SBIR grant for aerosol delivery of surfactant
KAER Biotherapeutics has received a $291,000 Phase 1 Small Business Innovation Research (SBIR) grant from the National Heart Lung and Blood Institute of the National Institutes of Health for “Aerosol delivery of Surfactant for ARDS,” the company said. The grant will fund a study of surfactant aerosolization and delivery for the treatment of acute respiratory distress … [Read more...] about KAER Biotherapeutics gets SBIR grant for aerosol delivery of surfactant
Breo/Relvar Ellipta study shows reduction in deaths not statistically significant
GSK and Theravance have announced that a study called SUMMIT (Study to Understand Mortality and MorbidITy in COPD ) showed that COPD patients treated with the Breo/Relvar Ellipta fluticasone furoate/vilanterol DPI had lower risk of dying than those treated with placebo, but the difference was not statistically significant. Almost 16,500 COPD patients who had either a … [Read more...] about Breo/Relvar Ellipta study shows reduction in deaths not statistically significant
Serendex to begin Phase 2 trial of inhaled molgramostim
According to Serendex Pharmaceuticals, German regulators have cleared the way for the company to initiate a phase 2 clinical trial of inhaled molgramostim (Molgradex) for the treatment of pneumonia-associated acute respiratory distress syndrome (ARDS). Earlier this year, the company announced that it had partnered with the Universities of Giessen and Marburg Lung … [Read more...] about Serendex to begin Phase 2 trial of inhaled molgramostim
Study finds that CF patients would give up 5+ years of their lives to use a DPI instead of a standard nebulizer
A study published online in the American Journal of Pharmaceutical Benefits on August 20, 2015 found that approximately 90% of adult cystic fibrosis patients surveyed preferred using a dry powder inhaler to using a standard nebulizer if the cost is the same. On average, the patients said that they would be willing to give up 5.3 years of life, out of an expected 40 … [Read more...] about Study finds that CF patients would give up 5+ years of their lives to use a DPI instead of a standard nebulizer
Phase 3 data show Stiolto/Spiolto Respimat improves quality of life
Boehringer Ingelheim has published new data from the two OTEMTO Phase 3b trials of the Stiolto/Spiolto Respimat tiotropium/olodaterol SMI for the treatment of COPD. The data show that the inhaler produced clinically meaningful improvements in quality of life versus placebo as measured by the St. George's Respiratory Questionnaire (SRGQ). The soft mist inhaler is … [Read more...] about Phase 3 data show Stiolto/Spiolto Respimat improves quality of life
Pulmatrix announces plans for Phase 1 trial of inhaled anti-fungal for CF, BE study for LAMA
According to an update from Pulmatrix, the company has enough capital to fund development of its inhaled drug portfolio through the middle of 2017, and its plans over the next year and a half include the initiation of a Phase 1 trial of PUR1900 for the treatment of cystic fibrosis, and a pharmacokinetic bioequivalence study of PUR0200 for the treatment of COPD. … [Read more...] about Pulmatrix announces plans for Phase 1 trial of inhaled anti-fungal for CF, BE study for LAMA
OptiNose reports positive results from Phase 1 trial of intranasal oxytocin for autism
OptiNose has announced that a study comparing OPN-300 intranasal oxytocin to intravenous oxytocin for the treatment of autism showed the achievement of similar blood levels but significantly greater social-cognitive effects after intranasal administration. The results were published online July 14, 2015 in Translational Psychiatry. The randomized, … [Read more...] about OptiNose reports positive results from Phase 1 trial of intranasal oxytocin for autism
Inhaled Ebola vaccine shows promise
A study published July 13, 2015 in the Journal of Clinical investigation demonstrated that an inhaled vaccine created by a team from The University of Texas Medical Branch at Galveston (UTMB) and the National Institutes of Health protected primates against the Ebola virus. The vaccine was aerosolized using a nebulizer and delivered through a mask to a group of … [Read more...] about Inhaled Ebola vaccine shows promise