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Phase 2 study of Promius Pharma’s intranasal sumatriptan meets primary endpoint

Dr. Reddy's subsidiary Promius Pharma has announced that a Phase 2 study of its DFN-02 intranasal sumatriptan for the treatment of migraine met its primary endpoint, the proportion of subjects free of migraine pain at 2 hours post dose. After 2 hours, 43.8% of patients treated with DFN-02 experienced migraine pain relief compared to 22.5% of patients who received … [Read more...] about Phase 2 study of Promius Pharma’s intranasal sumatriptan meets primary endpoint

InCarda announces positive Phase 1 results for inhaled flecainide

InCarda Therapeutics has announced that a Phase 1 study of InRhythm inhaled flecainide, which it is developing for the treatment of paroxysmal atrial fibrillation (PAF), met its primary and secondary endpoints, with all doses found to be safe and well tolerated and achieving effective plasma levels within 3 minutes. In 2015, InCarda established an Australian … [Read more...] about InCarda announces positive Phase 1 results for inhaled flecainide

Vectura reports positive Phase 1 results for VR942 inhaled biologic

Vectura has announced that it is presenting positive results from a Phase I clinical study of VR942, an inhaled anti-IL-13 monoclonal fragment antibody, at the American Thoracic Society 2017 International Conference. Vectura is partnered with UCB to develop VR942 as a treatment for severe asthma, and the companies expect to begin a Phase 2 study in the second half of … [Read more...] about Vectura reports positive Phase 1 results for VR942 inhaled biologic

Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial

Acorda Therapeutics will present new data from a Phase 3 trial of its CVT-301 inhaled L-dopa, which it is now calling Inbrija, at the International Congress of Parkinson’s Disease and Movement Disorders (MDS). The company has previously said that data from the Phase 3 SPAN-PD trial show that CVT-301 significantly improves motor function in Parkinson's Disease … [Read more...] about Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial

Positive Phase 2 results for Milestone’s intranasal etripamil

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

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