Milestone Pharmaceuticals has announced positive results from the Phase 2 NODE-1 study of intranasal etripamil for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT), a type of cardiac arrhythmia. The double-blind dose ranging study enrolled 104 patients who received 1 of 4 doses of intranasal etripamil or placebo after an induced PSVT … [Read more...] about Positive Phase 2 results for Milestone’s intranasal etripamil
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Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
The IMPALA Phase 2/3 trial for Savara's Molgradex inhaled molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) will be modified in order to qualify as a pivotal study for a US regulatory submission, the company said. According to Savara, the FDA has provided guidance on increasing enrollment and changing endpoint hierarchy and analysis … [Read more...] about Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
Salford Lung Study data show increased effectiveness of Relvar Ellipta for asthma compared to usual care
GlaxoSmithKline and Innoviva have announced that data from the real world Salford Lung Study show that asthma patients using Relvar (Breo) Ellipa fluticasone furoate/vilanterol 100/25μg or 200/25μg had improved asthma control compared to those using their usual care, either ICS or ICS/LABA combinations. Relvar Ellipta was approved for the treatment of asthma in the … [Read more...] about Salford Lung Study data show increased effectiveness of Relvar Ellipta for asthma compared to usual care
Positive Phase 1 results for Dauntless’s intranasal octreotide
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
Phase 3 trial of intranasal midazolam meets primary endpoint
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 to begin Phase 1 trial of AB569
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
Nemera to develop inhaled nanoparticle delivery devices as part of Project Cupido
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
Positive Phase 3 results for Glenmark’s mometasone/olopatadine nasal spray
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 initiates Phase 2 trial of intranasal naloxone for the treatment of bulimia nervosa
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
Positive results for Phase 1 study of inhaled oxytocin
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