Pearl Therapeutics has announced the initiation of a Phase 3 program called PINNACLE for its PT003 glycopyrrolate/formoterol fumarate metered dose inhaler for patients with moderate-to-severe COPD. The program will include two studies involving more than 2,700 patients in North America, Europe, Australia, and New Zealand. Enrollment is expected to be complete by … [Read more...] about Pearl Therapeutics initiates Phase 3 program for LAMA/LABA MDI
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More positive Phase 3 results for aclidinium/formoterol DPI
Almirall and Forest Labs have announced positive results from the Phase 3 AUGMENT/COPD study of their fixed dose combination aclidinium bromide/formoterol fumarate dry powder inhaler in patients with COPD. The announcement followed several weeks after the companies announced positive results from another Phase 3 study of aclidinium/formoterol, the ACLIFORM/COPD study. … [Read more...] about More positive Phase 3 results for aclidinium/formoterol DPI
QVA149 data demonstrates superior reduction of COPD exacerbations compared to glycopyrronium alone
Novartis's QVA149 indacaterol maleate/glycopyrronium DPI demonstrated 15% greater reduction in all COPD exacerbations compared to glycopyrronium and 14% compared to tiotropium according to study results published April 23 2013 in Lancet Respiratory Medicine. QVA149 reduced moderate-to-severe exacerbations by 12% over glycopyrronium. The study also showed improved lung … [Read more...] about QVA149 data demonstrates superior reduction of COPD exacerbations compared to glycopyrronium alone
Positive Phase 2 results for inhaled L-dopa
In a Phase 2 study of Civitas Therapeutics' CVT-301 inhaled levodopa (L-dopa), Parkinson's disease patients with motor fluctuations (OFF episodes) who used the drug experienced "rapid and durable" motor function improvement, the company announced. The 24-patient randomized, placebo-controlled study was funded in part by a grant from the Michael J. Fox Foundation. … [Read more...] about Positive Phase 2 results for inhaled L-dopa
Impel Neuropharma SPECT imaging study shows nose-to-brain delivery
According to Impel NeuroPharma, the results of a human proof of concept study using SPECT imaging demonstrated nose-to-brain delivery by its Precision Olfactory Delivery (POD) device. The company said that the SPECT images showed deposition of radiolabeled tripeptide by the POD device in the deep nasal cavity and bypassing of the blood brain barrier with delivery to … [Read more...] about Impel Neuropharma SPECT imaging study shows nose-to-brain delivery
Phase 2 study of Savara’s AeroVanc initated
Savara Pharmaceuticals has announced the commencement of a Phase 2 clinical trial of its AeroVanc inhaled dry powder vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. The randomized, double-blind, placebo-controlled study will involve 80 CF patients across the US. Results should be available … [Read more...] about Phase 2 study of Savara’s AeroVanc initated
Positive Phase 3 results for Almirall and Forest’s aclidinium/formoterol DPI
Almirall and Forest Laboratories have announced that a 6-month Phase 3 study of their aclidinium bromide/formoterol fumarate dry powder fixed dose combination delivered by the Genuair (Pressair) inhaler for the treatment of COPD demonstrated statistically significant improvements with both doses tested. The study of more than 1,700 patients found that both the … [Read more...] about Positive Phase 3 results for Almirall and Forest’s aclidinium/formoterol DPI
Phase 3 trial of Amikacin Inhale gets underway
Bayer HealthCare has announced the initiation of its Phase 3 program to evaluate the efficacy and safety of Amikacin Inhale in patients with Gram-negative pneumonia who are intubated and mechanically ventilated and being treated with intravenous antibiotics. Bayer is developing Amikacin Inhale in partnership with Nektar, and the inhalation solution is delivered by … [Read more...] about Phase 3 trial of Amikacin Inhale gets underway
Discovery Labs says Aerosurf program “currently remains on track”
According to Discovery Laboratories its Aerosurf aerosolized surfactant development program "currently remains on track for the Phase 2 clinical program in the fourth quarter of 2013" and is unaffected by the FDA's recent questions about product specifications for Discovery Labs' Surfaxin intratracheal suspension surfactant. The company says that it will respond to … [Read more...] about Discovery Labs says Aerosurf program “currently remains on track”
Asmacure initiates Phase 1/2 trial of ASM-024 DPI
Canadian respiratory drug developer Asmacure has dosed the first subjects in a Phase 1/2 clinical trial of its ASM-024 inhalation powder for the treatment of asthma, the company says. According to the company, "ASM-024 has a novel multi-functional mechanism of action with nicotinic and muscarinic effects and has demonstrated anti-inflammatory effects, … [Read more...] about Asmacure initiates Phase 1/2 trial of ASM-024 DPI