Medical

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 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

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 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

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

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

Pulmatrix has announced the completion of a Phase 1 pharmacokinetic study of its PUR0200 generic tiotropium DPI in healthy volunteers. Pulmatrix announced the initiation of the study in February 2016. The company has partnered with Mylan on development of PUR0200, which it says is "is focused on demonstrating bioequivalence between PUR0200 and a currently marketed … [Read more...] about Pulmatrix completes PK study of PUR0200

GlaxoSmithKline and Innoviva (formerly Theravance, Inc.) have announced data from the Salford Lung Study (SLS) showing that COPD patients using the Relvar Ellipta 100/25 mcg fluticasone furuoate/vilanterol DPI had an 8.41% lower rate of moderate or severe exacerbations compared to patients receiving LAMAs, LABAs, and/or ICS as monotherapy or in combination. Relvar … [Read more...] about Study shows superiority of Relvar (Breo) Ellipta to usual care in reducing COPD exacerbations