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
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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
Mast Therapeutics announces Phase 1/2 study of AIR001 for the treatment of P. aeruginosa infections in CF patients
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
GSK says study shows Relvar (Breo) Ellipta non-inferior to Seretide (Advair) for well-controlled asthma
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
Pharmaxis announces completion of treatment in Phase 3 trial of Bronchitol for CF
According to Pharmaxis, treatment has been concluded in a Phase 3 trial of its Bronchitol mannitol DPI for the treatment of cystic fibrosis. A total of 423 patients in 21 countries were treated in the 26-week randomized, double-blind parallel group study. The company expects to report topline results in the second quarter of 2017 and, if results are positive, to … [Read more...] about Pharmaxis announces completion of treatment in Phase 3 trial of Bronchitol for CF
Dauntless Pharmaceuticals initiates Phase 1 study of intranasal octreotide
Dauntless Pharmaceuticals has initiated a Phase 1 clinical study of its DP1038 intranasal octreotide acetate, the company said. The study will compare DP1038 to Sandostatin octreotide acetate injection in healthy volunteers. DP1038 is in development for the treatment of acromegaly and neuroendocrine tumors. In July 2014, Aegis Therapeutics announced that it was … [Read more...] about Dauntless Pharmaceuticals initiates Phase 1 study of intranasal octreotide
Windtree says aerosolized KL4 surfactant shows promise for treatment of flu in pre-clinical study
Windtree Therapeutics says a pre-clinical study in ferrets exposed to influenza demonstrated that the company's aerosolized KL4 surfactant increased survival and reduced lung inflammation, although the increase in survival rate was less than that for animals treated with oseltamivir (Tamiflu). Fewer clinical signs of influenza were observed in animals treated with KL4 … [Read more...] about Windtree says aerosolized KL4 surfactant shows promise for treatment of flu in pre-clinical study
Prevacus announces plans for Phase 1 study of PRV-002 intranasal therapy for concussion
Prevacus has announced that it plans to initiate a Phase 1 clinical trial of its PRV-002 intranasal product for the treatment of mild traumatic brain injury (mTBI) by the middle of 2017. According to the company, pre-clinical studies showed that intranasal administration of PRV-002 positively impacted memory, sensory-motor function, cerebral edema, anxiety and … [Read more...] about Prevacus announces plans for Phase 1 study of PRV-002 intranasal therapy for concussion
Spyryx Biosciences announces positive results from Phase 1 study of SPX-101
According to Spyryx Biosciences, a Phase 1 study of its SPX-101, an inhaled SPLUNC1-derived peptide that the company is developing for the treatment of cystic fibrosis, showed that the drug was well tolerated, with no reduction in lung function and no dose-limiting adverse effects. Based on those results, the company is planning a Phase 2 study in CF patients. The … [Read more...] about Spyryx Biosciences announces positive results from Phase 1 study of SPX-101