Medical

Auris Medical has announced results from a second Phase 1 study of its intranasal betahistine in 72 healthy volunteers that demonstrated superior bioavailability compared to oral betahistine for 4 doses of the nasal formulation, with plasma exposure up to 29 times higher. Earlier this year, Auris announced results from an earlier Phase 1 study and a pre-clinical … [Read more...] about Positive Phase 1 results for Auris Medical’s intranasal betahistine

Secarna Pharmaceuticals has announced that the Inhaled Nanocarriers with Antisense Therapy for lung fibrosis (INAT) project has received a 3-year grant to fund from the ERA-Net Cofund EuroNanoMed3, part of the EC's Horizon 2020 Framework Program for Research and Innovation. Secarna is part of a consortium for INAT that includes French, German, and Belgian universities … [Read more...] about Group developing inhaled antisense therapy for IPF gets funding through EuroNanoMed3

Just weeks after Janssen announced that it had submitted an NDA for its intranasal esketamine for the treatment of depression, the company has presented data from a Phase 3 trial of the nasal spray that failed to meet its primary endpoint. Positive results from a previous Phase 3 study were published in May 2018. The new data from a study that enrolled 346 adults … [Read more...] about Phase 3 trial of intranasal esketamine fails to meet primary endpoint

Impel NeuroPharma said that the first subject has been dosed in a Phase 1 study of INP105 intranasal dry powder olanzapine, which the company is developing for the treatment of acute agitation in bipolar I disorder and schizophrenia. The "SNAP 101" PK/PD trial will compare 3 doses of INP105 to 5 mg and 10 mg doses of intramuscular Zyprexa and to 10 mg of orally … [Read more...] about Impel initiates Phase 1 trial of INP105 intranasal olanzapine

AstraZeneca has announced that the Phase 3b AERISTO trial of Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for moderate to very severe COPD failed to meet 2 out of 3 of its primary endpoints, including non-inferiority to umeclidinium/vilanterol on trough FEV1 and superiority on peak FEV1. Bevespi Aerosphere did demonstrate non-inferiority on peak … [Read more...] about Disappointing results for Phase 3b study of Bevespi Aerosphere

Impel NeuroPharma said that the Phase 3 STOP-301 safety and tolerability study of INP104 intranasal dihydroergotamine (DHE) for the treatment of migraine has gotten underway, with the first patient dosed. The company announced plans for the study in June 2018. According to Impel, recruitment for the study, which will gather data at 24 weeks and 52 weeks of … [Read more...] about Impel initiates Phase 3 study of intranasal DHE for migraine

Vectura has announced results from a pharmacokinetic study of its VR647 nebulized budesonide inhalation suspension in asthma patients aged 4 to 8 and a methodology study of the use of a mouthpiece with the VR647 nebulizer (the Akita Jet nebulizer) by children aged 1 to 4. In January 2017, Vectura announced that it had received FDA approval of its IND for pediatric … [Read more...] about Vectura announces results from two studies of VR647 in pediatric asthma patients