Paradigm Biopharmaceuticals has announced the completion of a Phase 1 clinical trial of its Rhinosul pentosan polysulfate sodium (PPS) nasal spray for allergic rhinitis. Paradigm said that none of the 18 healthy volunteers involved in the study experienced any significant adverse effects and that it anticipates the final report in October 2016. The company also … [Read more...] about Paradigm Biopharmaceuticals completes Phase 1 trial of pentosan polysulfate sodium nasal spray
Medical
AstraZeneca announces positive results from two Symbicort studies
AstraZeneca has announced top-line results from the Phase 3 RISE (Revealing the Impact of Symbicort in reducing Exacerbations in COPD) and CHASE 3 (ChildHood Asthma Safety and Efficacy) studies of the Symbicort budesonide/formoterol fumarate MDI showing that Symbicort met the primary endpoints in both studies. The RISE study compared twice daily Symbicort MDI … [Read more...] about AstraZeneca announces positive results from two Symbicort studies
Windtree gets $2.6 million for Phase 2b trial of Aerosurf
Windtree Therapeutics has received $1 million from a Phase 2 Small Business Innovation Research Grant (SBIR) worth up to $2.6 million for a Phase 2b trial of its Aerosurf aerosolized KL4 surfactant in premature infants with respiratory distress syndrome (RDS) who are receiving nasal continuous positive airway pressure (nCPAP). The company previously received a … [Read more...] about Windtree gets $2.6 million for Phase 2b trial of Aerosurf
Mast Therapeutics initiates Phase 2 study of AIR001
According to Mast Therapeutics the first patient has been enrolled in a Phase 2 study of its AIR001 sodium nitrite inhalation solution in patients with heart failure with preserved ejection fraction (HFpEF). The multicenter, randomized, double-blind, placebo-controlled is expected to enroll 100 patients. The company announced earlier this year that the INDIE-HFpEF … [Read more...] about Mast Therapeutics initiates Phase 2 study of AIR001
Sunovion announces results of long-term safety study of glycopyrrolate inhalation solution
Sunovion has announced results from the Phase 3 GOLDEN-5 48-week safety study of SUN-101 glycopyrrolate inhalation solution in patients with moderate-to-very severe COPD. According to the company, the data show that SUN-101 was well tolerated, and the incidence of adverse events was similar to that of the active comparator, Spiriva Handihaler. The study enrolled 1,087 … [Read more...] about Sunovion announces results of long-term safety study of glycopyrrolate inhalation solution
McMaster researchers developing intranasal vaccine against chlamydia
Researchers at the Michael G. DeGroote Institute for Infectious Disease Research at McMaster University have published an article in the journal Vaccine describing promising results from a study of their intranasal BD584 chlamydial antigen against Chlamydia trachomatis, which can cause eye infections called trachoma that may result in blindness and can also cause … [Read more...] about McMaster researchers developing intranasal vaccine against chlamydia
Evoke’s Phase 3 trial of intranasal metoclopramide fails to meet primary endpoint
Evoke Pharma has announced that a Phase 3 trial of EVK-001 intranasal metoclopramide in 205 female diabetic gastroparesis patients failed to achieve its primary endpoint, which was improvement of symptoms at Week 4. EVK-001 and placebo treatment both produced similar improvement at Week 4. Results from a Phase 2b study announced in January 2014 had shown superior … [Read more...] about Evoke’s Phase 3 trial of intranasal metoclopramide fails to meet primary endpoint
Positive Phase 1 results for Pulmatrix’s PUR0200 DPI
Pulmatrix has announced topline results from the Phase 1 bioavailability trial of Pulmatrix's PUR0200 generic tiotropium DPI initiated in January 2016 and completed in May 2016. The company had previously announced positive Phase 1b results for a trial of PUR0200 in COPD patients. The 7-way crossover study involved 42 healthy subjects who each received a dose of … [Read more...] about Positive Phase 1 results for Pulmatrix’s PUR0200 DPI
Phase 3 study shows GSK’s FF/UMEC/VI combination improves lung function and quality of life better than Symbicort
GlaxoSmithKline and Innoviva have presented data from the FULFIL study of its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI versus Symbicort for COPD, reiterating that the data support the company's plans to file an NDA for the product by the end of the year as recently announced as well as filing for approval in the EU by the end of 2016. The study met … [Read more...] about Phase 3 study shows GSK’s FF/UMEC/VI combination improves lung function and quality of life better than Symbicort
Acorda presents data from Phase 1 study of CVT-427 inhaled zolmitriptan
Acorda Therapeutics will present data from a Phase 1 study of its CVT-427 zolmitriptan DPI at the Annual Scientific Meeting of the American Headache Society, the company has announced. According to the company, the data show that the bioavailability of CVT-427 exceeded that of oral and intranasal zolmitriptan with lower variability in plasma concentrations. Acorda, … [Read more...] about Acorda presents data from Phase 1 study of CVT-427 inhaled zolmitriptan