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
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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
Positive Phase 3 results for BI’s tiotropium/olodaterol Respimat
Boehringer Ingelheim has presented data from a 6-week Phase 3 study of its tiotropium/olodaterol soft mist inhaler in 219 moderate to severe COPD patients showing that patients using the fixed dose combination had significantly greater improvements in FEV1 than those using either placebo or tiotropium or olodaterol monotherapy. Safety data were similar for the … [Read more...] about Positive Phase 3 results for BI’s tiotropium/olodaterol Respimat
Insmed announces additional positive results for Arikayce
Insmed has presented additional positive results from the open label portion of a Phase 2 trial of Arikayce inhaled liposomal amikacin for the treatment-resistant nontuberculous mycobacterial (NTM) lung infections at the American Thoracic Society annual meeting. Previously announced results from the trial were mixed. The 84-day open label phase involved 78 of the … [Read more...] about Insmed announces additional positive results for Arikayce
Kamada pivotal study of inhaled AAT fails to meet primary endpoint
Kamada has announced that preliminary results from its Phase 2/3 pivotal trial of its inhaled Alpha-1 Antitrypsin (AAT) therapy showed no difference between inhaled AAT and placebo in “time to first moderate or severe exacerbation,” the primary endpoint. The 50-week study involved 168 patients. The company said that the frequency of severe exacerbations in patients … [Read more...] about Kamada pivotal study of inhaled AAT fails to meet primary endpoint