Medical

Pulmatrix has announced that a pilot bioequivalence study of 5 formulations of its PUR0200 DPI for the treatment of COPD has begun enrollment. The company is partnered with Mylan on development of the DPI. According to Pulmatrix, enrollment of 42 healthy volunteers for the study should be completed by the end of the first quarter of 2016, and results should be … [Read more...] about Pulmatrix bioequivalence study of PUR0200 gets underway

Mast Therapeutics says that top-line results from a Phase 2a study of its AIR001 sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) demonstrated statistically significant change in pulmonary capillary wedge pressure (PCWP) during exercise compared to placebo, which was the primary endpoint. Mast acquired … [Read more...] about Positive Phase 2a results for Mast’s AIR001 for the treatment of heart failure

Milestone Pharmaceuticals has announced today that its MSP-2017 intranasal calcium channel antagonist has been assigned the unique non-proprietary name "etripamil" by the United States Adopted Name (USAN) Council. The company is developing the etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone CEO Philippe Douville … [Read more...] about Milestone’s intranasal calcium channel antagonist gets generic name “etripamil”

Neurelis says that it has received guidance from the FDA regarding clinical trial requirements for the company's NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients and is now initiating the pivotal trial program for the product. Neurelis President and CEO Craig C. Chambliss commented, "We were pleased to obtain guidance … [Read more...] about Neurelis announces initiation of pivotal trials for intranasal diazepam

Turing Pharmaceuticals said that it has received a no objection letter from Health Canada regarding the initiation of Phase 1 trials of TUR-002 intranasal ketamine for the reduction of suicidal ideations and that it expects to complete the trials by mid-2016. The timing is in line with a November 2015 announcement from Turing that was made prior to the arrest and … [Read more...] about Turing says that it is initiating Phase 1 clinical trials for intranasal ketamine

Cipla has announced the launch of a mobile app called “My Breathefree,” which is intended to serve as a "virtual caregiver" for asthma patients in India. The app includes video demonstrations of correct use for various types of inhalers in 10 languages, as well as dose reminders, tracking tools for peak expiratory flow rate, a "trigger map," and other resources from … [Read more...] about Cipla launches mobile app for management of asthma in India

Discovery Laboratories has announced the initiation of a Phase 2b trial of Aerosurf aerosolized KL4 surfactant to treat respiratory distress syndrome (RDS) in premature infants. The trial, which is expected to enroll up to 250 patients will compare outcomes for infants receiving Aerosurf plus non-invasive nasal continuous positive airway pressure (nCPAP) to outcomes … [Read more...] about Discovery Labs initiates Phase 2b trial of Aerosurf

Alexza Pharmaceuticals has announced interim results from a Phase 2a study of AZ-002 inhaled alprazolam in epilepsy patients. Dose-related decreases in mean standardized photosensivity range (SPR), the study's primary endpoint, were noted 2 minutes post inhalation for 2 of the 3 doses tested, the company said. According to Alexza, AZ-002 was also well tolerated with … [Read more...] about Alexza announces interim results from Phase 2a study of AZ-002