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Second Phase 3 trial of Aradigm’s Pulmaquin gets underway

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

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