According to an article published online in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine, only about a third of asthma patients not using an inhaled corticosteroid (ICS) and 17% of those using ICS had eosinophils in their sputum, an indicator of inflammation that suggests they would likely respond to ICS treatment. The … [Read more...] about Many patients with mild-to-moderate asthma may not respond to ICS
Medical
St Renatus gets funding for Phase 3 development of nasal spray dental anesthesia
An unnamed angel investment group is providing up to $3.5 million dollars to St. Renatus for Phase 3 clinical trials of its nasal mist dental anesthesia. St. Renatus announced in March 2011 that it had had a successful end-of-Phase 2 meeting with FDA regulators and planned to move ahead with Phase 3. The product, delivered to the nasal cavity, numbs only the upper … [Read more...] about St Renatus gets funding for Phase 3 development of nasal spray dental anesthesia
GSK says “totality of the data” gives it confidence to submit applications for Relovair
GlaxoSmithKline and Theravance have announced the completion of Phase 3 studies of their Relovair fluticasone furoate/vilanterol DPI for COPD. One Phase 3 study for the treatment of asthma remains to be completed. Despite the fact that the studies failed to produce statistically significant improvements in a number of measures, GSK says that it will submit … [Read more...] about GSK says “totality of the data” gives it confidence to submit applications for Relovair
Pearl ready to begin Phase 3 studies of PT003
According to Pearl Therapeutics, it has completed two Phase 2b clinical studies of PT003, its inhaled combination bronchodilator for the treatment of moderate-to-severe COPD, and is "on-track to commence Phase 3 program in 2012." One of the trials was a dose confirmation study of various doses of PT003 compared to its components, PT001 and PT005; the other was a … [Read more...] about Pearl ready to begin Phase 3 studies of PT003
Positive Phase 1 results for inhaled L-dopa
Civitas Therapeutics has announced positive results from a Phase 1 clinical study of its CVT-301 inhaled dry powder formulation of levodopa (L-dopa) for the treatment of Parkinson’s disease. According to the company, the study showed that all of the doses tested were well tolerated, and sufficient plasma levels of L-dopa were achieved in healthy volunteers who inhaled … [Read more...] about Positive Phase 1 results for inhaled L-dopa
Phase 2 study of ISTA’s bepotastine-steroid nasal spray begins
ISTA Pharmaceuticals says that it has initiated a Phase 2 study of its Beposone bepotastine besilate/steroid combination nasal spray for the treatment of seasonal allergic rhinitis. Approximately 600 patients with allergic rhinitis caused by mountain cedar pollen are expected to take part in the randomized, placebo-controlled, parallel-group environmental study, which … [Read more...] about Phase 2 study of ISTA’s bepotastine-steroid nasal spray begins
Pulmatrix says iSperse data show superiority over lactose blends for DPIs
Pulmatrix has presented data at the 11th US-Japan Symposium on Drug Delivery Systems in Hawaii that it says demonstrate the superiority of its iSPERSE inhalation platform over lactose formulations for combination dry powder inhalers. The iSPERSE technology makes use of a "delivery matrix containing proprietary cationic salt formulations" that allows for increased … [Read more...] about Pulmatrix says iSperse data show superiority over lactose blends for DPIs
Intranasal norovirus vaccine capable of reducing infection
An article published in the December 8, 2011 issue of the New England Journal of Medicine describes a proof of principle study in which an intranasal dry powder vaccine significantly reduced Norwalk virus gastroenteritis and infection in study participants innoculated with Norwalk virus. LigoCyte Pharmaceuticals created the vaccine from virus-like particles since … [Read more...] about Intranasal norovirus vaccine capable of reducing infection
Positive Phase 2b results for Pearl’s PT001
Pearl Therapeutics has announced positive top-line results from a Phase 2b dose-ranging study of its PT001 glycopyrrolate (GP) MDI in patients with moderate-to-severe COPD. The randomized, double-blind study compared 4 doses of the PT001 MDI to placebo and to Atrovent HFA inhalation aerosol. According to Pearl all of the doses of GP tested demonstrated statistically … [Read more...] about Positive Phase 2b results for Pearl’s PT001
Daily low dose budesonide inhalation not superior to intermittent high dose treatment in young children
According to a study published in the November 24 issue of the New England Journal of Medicine, intermittent administration of a high dose of inhaled budesonide resulted in no more exacerbations over the course of a year in young children with asthma than daily inhalation of a low dose, and the intermittent regimen resulted in significantly lower budesonide exposure. … [Read more...] about Daily low dose budesonide inhalation not superior to intermittent high dose treatment in young children