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
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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
Aptar publishes summary of roundtable on inhaler adherence
Aptar Pharma has published a white paper summarizing a roundtable discussion on inhaler adherence held in Paris, France on November 29th 2013. The panel included five experts on inhaler usage from the UK and France. The company said, "Aptar Pharma and its distinguished scientific guests were delighted with the successful outcome of the inhaler adherence … [Read more...] about Aptar publishes summary of roundtable on inhaler adherence
Positive Phase 1b results for Pulmatrix LAMA DPI
Pulmatrix has announced that a recently completed Phase 1b study of its PUR0200 inhaled LAMA in COPD patients found that all three doses of PUR0200 produced significant improvement in lung function compared to placebo and comparable or greater to an active comparator. The company had announced initiation of the study in July 2013. PUR0200 is a carrier-free dry … [Read more...] about Positive Phase 1b results for Pulmatrix LAMA DPI
Clinical trials underway for inhaled immune system stimulant
According to an announcement from the Texas A&M Health Science Center (TAMHSC), Texas-based biotech Pulmotect has initiated clinical trials of PUL-042, an inhaled immune system stimulant. In 2012, the company received a grant of over $7 million for development of PUL-042, which was designed by researchers at TAMHSC and the University of Texas MD Anderson Cancer … [Read more...] about Clinical trials underway for inhaled immune system stimulant
VR1 presents poster on intranasal capsaicin for headache
The makers of a homeopathic capsaicin nasal spray are presenting a poster featuring "real-world patient case series analysis supporting the use of intranasal capsaicin as an effective rapid treatment for severe headache and migraine pain" at the 2014 American Academy of Neurology (AAN) Annual Meeting. VR1, Inc. recently launched an intranasal capsaicin product, … [Read more...] about VR1 presents poster on intranasal capsaicin for headache