Medical

Dauntless Pharmaceutical has announced positive results from a Phase 1 trial of its DP1038 intranasal octreotide acetate, which it is developing for the treatment of acromegaly and neuroendocrine tumors. The company had announced initiation of the trial in February 2017. The PK/PD trial first compared 3 doses of intranasal octreotide acetate to 100 μg of … [Read more...] about Positive Phase 1 results for Dauntless’s intranasal octreotide

Upsher Smith subsidiary Proximagen has announced that the Phase 3 ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray) study of its USL261 intranasal midazolam for the treatment of seizure clusters, met its primary efficacy endpoint. Proximagen says that it plans to submit a 505(b)(2) NDA for the product by the end of the year. The primary … [Read more...] about Phase 3 trial of intranasal midazolam meets primary endpoint

Arch Biopartners said that it has begun manufacturing clinical trial supplies for a Phase 1 study of its AB569 sodium nitrite/ethylenediaminetetraacetic acid (EDTA) inhalation solution for the treatment of antibiotic-resistant bacterial lung infections, and the trial will begin as soon as the supplies are available. The study will evaluate PK and safety data of … [Read more...] about Arch Biopartners to begin Phase 1 trial of AB569

Device company Nemera has announced that it will develop devices for the delivery of inhaled nanoparticles for the treatment of cardiovascular disease as part of the Cupido (Cardio Ultraefficient Nanoparticles For Inhalation Of Drug Products) consortium. The Cupido project, funded by the €6 million from the EU Horizon 2020 Framework Program, has set as its goal, … [Read more...] about Nemera to develop inhaled nanoparticle delivery devices as part of Project Cupido

Glenmark Pharmaceuticals says that data from a Phase 3 study of its GSP 301 mometasone furoate/olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis show statistically significant and clinically meaningful improvement in symptoms compared to placebo and to the individual components. The two-week study enrolled 1,176 patients 12 … [Read more...] about Positive Phase 3 results for Glenmark’s mometasone/olopatadine nasal spray

Opiant Pharmaceuticals (formerly Lightlake Therapeutics) has announced the initiation of a Phase 2 trial of its OPNT001 intranasal naloxone for the treatment of bulimia nervosa. In 2014, the company licensed its Narcan intranasal naloxone for the reversal of opioid overdose to Adapt Pharma, and that product was approved in the US in November 2015. The upcoming … [Read more...] about Opiant initiates Phase 2 trial of intranasal naloxone for the treatment of bulimia nervosa

The Monash University Institute of Pharmaceutical Sciences (MIPS) has announced positive results from a Phase 1 study of inhaled oxytocin in healthy volunteers. The study was conducted by GSK, which is partnered with Monash University to develop inhaled oxytocin for the treatment of postpartum hemorrhage. According to MIPS, the PK data presented at the Royal … [Read more...] about Positive results for Phase 1 study of inhaled oxytocin

According to Mast Therapeutics, the University of Pittsburgh will conduct a Phase 1/2 open-label safety and proof of concept clinical trial of AIR001 sodium nitrite inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. Mast subsidiary Aires Pharmaceuticals will get rights to the data but is providing no support other than … [Read more...] about Mast Therapeutics announces Phase 1/2 study of AIR001 for the treatment of P. aeruginosa infections in CF patients

GlaxoSmithKline has announced that a lung function study to demonstrate non-inferiority for once-daily use of the Relvar (Breo) Ellipta fluticasone furoate/vilanterol DPI compared to twice-daily Seretide (Advair) fluticasone propionate/salmeterol DPI in patients with well-controlled asthma met its primary endpoint. In 2013, Relvar Ellipta was approved by the EU … [Read more...] about GSK says study shows Relvar (Breo) Ellipta non-inferior to Seretide (Advair) for well-controlled asthma