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Medical

Paper compares multi-component particles to mixed powders for inhaled combination therapies

A review paper published in the Spring 2012 issue of European Respiratory Disease contends that, "Drug delivery to lungs with a consistent and predesigned ratio of co-associated active components can help maximise the chance of co-location at the active site and hence increases the potential of synergistic action from the solid." Authored by Dipesh Parikh, David … [Read more...] about Paper compares multi-component particles to mixed powders for inhaled combination therapies

Upsher-Smith recruiting for Phase 3 study of midazolam nasal spray

Upsher-Smith Laboratories is recruiting patients aged 14-65 with partial or generalized epilepsy who experience seizure clusters for an ongoing Phase 3 clinical trial called ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray). As part of the recruiting effort, the company has launched a website, www.seizureclusterstudy.com. Upsher-Smith is … [Read more...] about Upsher-Smith recruiting for Phase 3 study of midazolam nasal spray

Positive Phase 2 topline results for ISTA’s Beposone nasal spray

ISTA Pharmaceuticals has announced results from a Phase 2 randomized, placebo-controlled, parallel-group environmental clinical study of its Beposone bepotastine besilate/steroid nasal spray for the treatment of seasonal allergic rhinitis. According to the company, the study showed that Beposone produced statistically significant improvements in nasal symptoms of … [Read more...] about Positive Phase 2 topline results for ISTA’s Beposone nasal spray

Asmanex Twisthaler shortage

The FDA issued a drug shortage alert for the Asmanex Twisthaler 110 mcg mometasone furoate inhalation Powder, 30 inhalation units, as of April 26, 2012. According to the FDA web site, the shortage is due to manufacturing delays and the expected duration is unknown. The 110 mcg dose Asmanex Twisthaler is recommended for the treatment of asthma in children ages 4-11 … [Read more...] about Asmanex Twisthaler shortage

Savara’s AeroVanc inhaled vancomycin well tolerated in Phase 1a study

Savara Pharmaceuticals has announced top-line data from a Phase 1a study of its AeroVanc vancomycin hydrochloride inhalation powder for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients. According to the company, the study, which compared single ascending doses of AeroVanc with intravenous vancomycin in healthy … [Read more...] about Savara’s AeroVanc inhaled vancomycin well tolerated in Phase 1a study

Novartis expected to file NDAs for QVA149 and NVA237 in 2014

According to Sosei, Novartis and the FDA have agreed on Phase 3 trial design for QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide, which should put the company on track to file an application for NVA237 early in 2014 and an application for QVA149 by the end of that year. Novartis licensed NVA 237 from Sosei and Vectura. Both Sosei and … [Read more...] about Novartis expected to file NDAs for QVA149 and NVA237 in 2014

MicroDose Therapeutx completes Phase 1 studies of inhaled antiviral fusion inhibitor for RSV

Two Phase 1 studies of MDT-637 inhaled antiviral fusion inhibitor for the treatment of RSV infection have demonstrated that the drug is well tolerated and causes no significant changes in lung function, MicroDose Therapeutx has announced. The double-blind, randomized, placebo-controlled dose-ranging studies also showed that MDT-637 reached the respiratory tract at … [Read more...] about MicroDose Therapeutx completes Phase 1 studies of inhaled antiviral fusion inhibitor for RSV

Synairgen announces positive Phase 2 results for inhaled interferon beta

UK-based Synairgen has announced positive data from a Phase 2 trial of its SNG001 inhaled interferon beta as protection against the common cold and other respiratory viral infections in asthma patients. According to the company, SNG001 showed statistically significant improvements compared to placebo in prevention of symptom worsening during the first week of … [Read more...] about Synairgen announces positive Phase 2 results for inhaled interferon beta

Positive Phase 1 results for dry powder intranasal zolmitriptan

Shin Nippon Biomedical Laboratories has announced results from a Phase 1 study of its intranasal zolmitriptan formulation (TRZ) for the treatment of migraine headaches. The company is developing several intranasal drugs based on its μco muco-adhesive powder carrier system and intranasal powder delivery device. According to SNBL, the study, which compared three … [Read more...] about Positive Phase 1 results for dry powder intranasal zolmitriptan