According to Aradigm, the first patient in the Phase 3 ORBIT-4 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial of Pulmaquin inhaled ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis has been dosed. The other Phase 3 trial, ORBIT-3, began in April 2014. Both 48-week double-blind trials expect to enroll about 255 patients and … [Read more...] about Second Phase 3 trial of Aradigm’s Pulmaquin gets underway
Medical
Verona Pharma halts development of inhaled antitussive
Verona Pharma has announced that it will stop development of its VRP700 inhaled antitussive after the drug failed to produce statistically significant reduction in cough frequency compared to placebo in a Phase 2a clinical trial. The trial evaluated the efficacy of a single dose of VRP700 in 20 idiopathic pulmonary fibrosis patients with severe chronic cough. … [Read more...] about Verona Pharma halts development of inhaled antitussive
Asmacure announces Phase 1/2a trial results for ASM-024 inhalation powder
Asmacure has announced that a Phase 1/2a trial of ASM-024 inhalation powder found that the drug was safe and well tolerated. In April 2013, the company announced that it had dosed the first patient in the study. The Phase 1 portion of the trial was a single ascending dose study in 40 healthy subjects; the Phase 2a portion of the trial involved 15 asthma patients … [Read more...] about Asmacure announces Phase 1/2a trial results for ASM-024 inhalation powder
Positive Phase 3 results for Incruse Ellipta plus Breo/Relvar Ellipta
GlaxoSmithKline and Theravance have announced that two Phase 3 studies have shown that COPD patients using the Incruse Ellipta umeclidinium (UMEC) DPI in conjunction with the Breo/Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI achieved a statistically significant greater improvement in FEV1 compared to patients using Breo/Relvar plus a placebo. A total … [Read more...] about Positive Phase 3 results for Incruse Ellipta plus Breo/Relvar Ellipta
Positive Phase 3 results for Avanir’s intranasal sumatriptan
Avanir Pharmaceuticals and OptiNose have announced that a Phase 3b trial demonstrated that acute migraine patients experienced greater pain relief within 30 minutes of dosing using Avanir's AVP-825 intranasal sumatriptan powder than patients taking sumatriptan 100mg tablets. In addition, a greater percentage of patients using AVP-825 were free of pain at 15 minute … [Read more...] about Positive Phase 3 results for Avanir’s intranasal sumatriptan
Grifols makes $5 million milestone payment to Aradigm as Pulmaquin Phase 3 trial begins
Aradigm has received a $5 million milestone payment from Grifols as the ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial of Pulmaquin inhaled ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis gets underway, the company announced. In May 2013, Grifols paid $25 million upfront to license Aradigm's inhaled ciprofloxacin … [Read more...] about Grifols makes $5 million milestone payment to Aradigm as Pulmaquin Phase 3 trial begins
Parion announces management changes
Parion Sciences, which is developing a trans-nasal aerosol delivery system and several products for cystic fibrosis, has announced several changes to its executive team. Paul Boucher, previously VP of Finance & Business has been promoted to President; Joe Schachle, previously Head of Global Marketing Operations at Grifols, has been hired as Chief Operating Officer; … [Read more...] about Parion announces management changes
Positive Phase 2 results for Trimel’s Tefina nasal testosterone
Trimel Pharmaceuticals has announced that an 84-day Phase 2 trial of its Tefina testosterone nasal gel for the treatment of anorgasmia in women found that the lowest of three doses tested produced a statistically significant increase in the number of orgasms experienced compared to placebo. The study involved more than 250 women in the US, Canada, and Australia. … [Read more...] about Positive Phase 2 results for Trimel’s Tefina nasal testosterone
Study shows reminders significantly improved inhaler adherence but increased adherence did not greatly improve asthma control
A six-month study conducted by the Woolcock Institute of Medical Research (WIMR) found that patients getting reminders from the Smartinhaler SmartTrack inhaler monitoring system manufactured by Nexus6 took 73% of prescribed doses on average compared to 46% for patients not using a reminder system. However, despite the significant difference in adherence between the … [Read more...] about Study shows reminders significantly improved inhaler adherence but increased adherence did not greatly improve asthma control
AZTherapies moving forward with Phase 3 study of inhaled Alzheimer’s therapy
Boston-based AZTherapies says that it plans to initiate a Phase 3 study of its ALZT-OP1, an inhaled combination product for the prevention and treatment of Alzheimer's disease, by the end of 2014 now that it has gotten the go-ahead from the FDA. Both drugs used in the combination therapy are already approved in the US, and the company plans to use data from the trial … [Read more...] about AZTherapies moving forward with Phase 3 study of inhaled Alzheimer’s therapy