Upsher-Smith Laboratories has presented data from a Phase 1 study of its USL261 midazolam nasal spray in children with epilepsy demonstrating that the median Tmax for 1.25 mg, 2.5 mg and 5 mg single doses was ~15 minutes and Cmax was not dose dependent. According to the company, the FDA has granted both fast track and orphan drug designations to USL261 for rescue … [Read more...] about Upsher-Smith reports results from Phase 1 study of midazolam nasal spray in children
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Windtree Therapeutics announces data from deposition study using its aerosol delivery system
Windtree Therapeutics has announced that a lung deposition study in cynomolgus macaques showed that its proprietary aerosol delivery system (ADS) delivered KL4 surfactant uniformly to all regions of the lung. The ADS is being developed to deliver Windtree's Aerosurf inhaled lucinactant, which is in Phase 2 development for the treatment of respiratory distress syndrome … [Read more...] about Windtree Therapeutics announces data from deposition study using its aerosol delivery system
Eurocine Vaccines begins Phase 1/2 study of intranasal flu vaccine
Eurocine Vaccines has started a Phase 1/2 clinical study of its Immunose FLU intranasal quadrivalent influenza vaccine, which uses the company's Endocine adjuvent and inactivated split antigens, the company said. Results should be available in mid-2017. Eurocine Vaccines Chief Scientific Officer Anna-Karin Maltais said, "We are very pleased that our nasal influenza … [Read more...] about Eurocine Vaccines begins Phase 1/2 study of intranasal flu vaccine
Sunovion partners with CHEST for “Delivery Makes a Difference” initiative
Sunovion Pharmaceuticals and the American College of Chest Physicians (CHEST) have launched an initiative called "Delivery Makes a Difference," which they say "seeks to understand patient and health care provider practices and to provide tools for matching patients with appropriate medications and delivery devices." According to the announcement, a steering … [Read more...] about Sunovion partners with CHEST for “Delivery Makes a Difference” initiative
Mylan and Theravance announce positive Phase 3 results for inhaled revefenacin for COPD
Theravance Biopharma and Mylan have announced that two 12-week Phase 3 efficacy studies of nebulized revefenacin (TD-4208) for the treatment of COPD have met their primary efficacy endpoint of statistically significant increase in FEV1 for both doses studied compared to placebo. Patients receiving the 88 mcg dose averaged a 118 mL increase in tough FEV1 after 12 weeks … [Read more...] about Mylan and Theravance announce positive Phase 3 results for inhaled revefenacin for COPD
Aradigm and Woolcock Institute of Medical Research get grant for development of aerosol nanotechnology
Aradigm Corporation has partnered with Professors Daniela Traini and Paul Young of the University of Sydney's Woolcock Institute of Medical Research to develop an aerosol nanoparticle technology to combat fungal and bacterial biofilms. The project will be funded by a A$420,000 grant from an Australian Research Council Linkage Project over three years. According to … [Read more...] about Aradigm and Woolcock Institute of Medical Research get grant for development of aerosol nanotechnology
Sumatriptan nasal spray shortage expected to be resolved by February 2017
According to an FDA drug shortages report, the US shortage of sumatriptan nasal spray due to a shortage of active ingredient that was first reported in November 2015 should be completely resolved by February 2017. At this time, both GlaxoSmithKline and Sandoz are reported to have 5 mg/spray versions of the nasal spray available, and GSK has the 20 mg product … [Read more...] about Sumatriptan nasal spray shortage expected to be resolved by February 2017
Raptor presents data on Quinsair efficacy
Raptor Pharmaceutical has presented results from a network meta-analysis of data from clinical trials of inhaled tobramycin, colistimethate sodium, aztreonam and levofloxacin for the treatment of P. aeruginosa lung infections in CF patients. The data, which were presented at the 2016 European Respiratory Society International Congress, show the efficacy of its … [Read more...] about Raptor presents data on Quinsair efficacy
Positive Phase 2 results for Patara’s inhaled treatment for chronic cough in IPF patients
Patara Pharma has announced Phase 2 results for its PA101 inhaled treatment for refractory chronic cough in patients with idiopathic pulmonary fibrosis (IPF) showing that patients receiving PA101 experienced a statistically significant reduction in cough frequency after 14 days compared to patients receiving a placebo. PA101 is delivered via the PARI eFlow nebulizer … [Read more...] about Positive Phase 2 results for Patara’s inhaled treatment for chronic cough in IPF patients
Flutiform fails to meet primary endpoint in Phase 3 trial for COPD
According to Vectura, Mundipharma's Phase 3 trial of the flutiform fluticasone/formoterol MDI failed to demonstrate statistically significant superiority compared to formoterol alone in reducing moderate and severe COPD exacerbations. Mundipharma had planned to seek approval from European regulators to market flutiform for the treatment of COPD but will now put off … [Read more...] about Flutiform fails to meet primary endpoint in Phase 3 trial for COPD