Lightlake Therapeutics has announced preliminary results from a Phase 2 trial of its intranasal naloxone for the treatment of patients with binge eating disorder. According to the company, the randomized, double-blind, placebo-controlled trial demonstrated that patients using the naloxone nasal spray spent a significantly smaller amount of time binge eating than did … [Read more...] about Positive Phase 2 results for nasal spray to treat binge eating disorder
Medical
Sunovion to launch Zetonna ciclesonide nasal aerosol in the US by Fall 2012
Sunovion has announced that it will make its Zetonna ciclesonide nasal aerosol for the treatment of allergic rhinitis available in the US in time for the fall allergy season. The FDA approved Zetonna, an HFA formulation delivered by nasal pMDI, in January 2012. Sunovion markets two other ciclesonide aerosols in the US: Omnaris nasal spray for the treatment of … [Read more...] about Sunovion to launch Zetonna ciclesonide nasal aerosol in the US by Fall 2012
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