Medical

In a Phase 2 study of Civitas Therapeutics' CVT-301 inhaled levodopa (L-dopa), Parkinson's disease patients with motor fluctuations (OFF episodes) who used the drug experienced "rapid and durable" motor function improvement, the company announced. The 24-patient randomized, placebo-controlled study was funded in part by a grant from the Michael J. Fox Foundation. … [Read more...] about Positive Phase 2 results for inhaled L-dopa

According to Impel NeuroPharma, the results of a human proof of concept study using SPECT imaging demonstrated nose-to-brain delivery by its Precision Olfactory Delivery (POD) device. The company said that the SPECT images showed deposition of radiolabeled tripeptide by the POD device in the deep nasal cavity and bypassing of the blood brain barrier with delivery to … [Read more...] about Impel Neuropharma SPECT imaging study shows nose-to-brain delivery

Savara Pharmaceuticals has announced the commencement of a Phase 2 clinical trial of its AeroVanc inhaled dry powder vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. The randomized, double-blind, placebo-controlled study will involve 80 CF patients across the US. Results should be available … [Read more...] about Phase 2 study of Savara’s AeroVanc initated

Almirall and Forest Laboratories have announced that a 6-month Phase 3 study of their aclidinium bromide/formoterol fumarate dry powder fixed dose combination delivered by the Genuair (Pressair) inhaler for the treatment of COPD demonstrated statistically significant improvements with both doses tested. The study of more than 1,700 patients found that both the … [Read more...] about Positive Phase 3 results for Almirall and Forest’s aclidinium/formoterol DPI

Bayer HealthCare has announced the initiation of its Phase 3 program to evaluate the efficacy and safety of Amikacin Inhale in patients with Gram-negative pneumonia who are intubated and mechanically ventilated and being treated with intravenous antibiotics. Bayer is developing Amikacin Inhale in partnership with Nektar, and the inhalation solution is delivered by … [Read more...] about Phase 3 trial of Amikacin Inhale gets underway

Canadian respiratory drug developer Asmacure has dosed the first subjects in a Phase 1/2 clinical trial of its ASM-024 inhalation powder for the treatment of asthma, the company says. According to the company, "ASM-024 has a novel multi-functional mechanism of action with nicotinic and muscarinic effects and has demonstrated anti-inflammatory effects, … [Read more...] about Asmacure initiates Phase 1/2 trial of ASM-024 DPI

According to Activaero, a Phase 2 trial of a budesonide suspension delivered using its FAVORITE (Flow and Volume Controlled Inhalation Technology) system in children with mild to moderate asthma improved asthma control, reduced treatment times, and required lower doses of the drug. In the proof-of-concept study, 41 German children aged 3 to 11 with mild to moderate … [Read more...] about Positive Phase 2 results for Activaero budesonide delivery study

According to AstraZeneca, data from the PATHOS real world study show fewer exacerbations and fewer hospitalizations for COPD patients treated with the Symbicort Turbuhaler than for those treated with Seretide (Advair). The study was published online in the Journal of Internal Medicine. The PATHOS study reviewed the medical records of 5,468 patients in Sweden who were … [Read more...] about AstraZeneca says study shows COPD treatment with budesonide/formoterol beats fluticasone/salmeterol

Acorda Therapeutics presented data from a Phase 1 study of its diazepam nasal spray at the American Academy of Neurology Annual Meeting this week showing that the plasma bioavailability of a 20 mg dose of diazepam nasal spray was comparable to that of a 20 mg dose of diazepam rectal gel. The company acquired the product, which is being developed for the treatment of … [Read more...] about Acorda Phase 1 data shows diazepam nasal spray has comparable biovailability to rectal gel