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
Medical
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
Single batch of Omnaris nasal spray recalled in Hong Kong
According to the Hong Kong Department of Health (DH), Nycomed (Hong Kong) has voluntarily recalled a batch of Omnaris ciclesonide nasal spray due "a quality defect." The product, from batch number 137930, was manufactured in Germany by Nycomed Gmbh in August 2010. The DH says that it was notified by Nycomed Gmbh that it had found pinholes in some of the foil … [Read more...] about Single batch of Omnaris nasal spray recalled in Hong Kong
Almirall and Forest initiate Phase 3 trial of aclidinium/formoterol DPI
Two Phase 3 studies to evaluate the safety of twice daily doses of a fixed dose combination dry powder formulation of aclidinium bromide and formoterol fumarate in 3,500 patients with moderate to severe COPD have been initiated by Almirall and its US partner, Forest Laboratories. The 24-week studies are taking place in Europe and North America, along with a 52-week … [Read more...] about Almirall and Forest initiate Phase 3 trial of aclidinium/formoterol DPI
Positive results for intranasal Ampion
Ampio Pharmaceuticals has announced results of a randomized, double-blinded study of its intranasal Ampion, a biologic anti-inflammatory, for the treatment of nasal inflammation. According to the company, Ampion "is naturally produced by humans in response to injury and is present in commercial human serum albumin (HSA) preparations." Ampio is also developing oral and … [Read more...] about Positive results for intranasal Ampion
Discovery Labs announces progress on inhaled therapies
Within the last week, Discovery Laboratories has announced that its aerosolized KL4 surfactant has received orphan drug designation from the EU for the treatment of cystic fibrosis, and it has presented data on a new product, Afectair, which it calls "a series of proprietary ventilator circuit/patient interface connectors and related componentry" that "simplifies the … [Read more...] about Discovery Labs announces progress on inhaled therapies
Positive Phase 3 results for ciclesonide nasal aerosol for perennial allergic rhinitis
Sunovion is presenting results from a 26-week double-blind, randomized Phase 3 study of ciclesonide HFA nasal aerosol involving more than 1,100 patients with perennial allergic rhinitis (PAR) that showed statistically significant improvement in nasal symptoms for ciclesonide compared to placebo. The study demonstrated positive results for both a 74 mcg dose and a 148 … [Read more...] about Positive Phase 3 results for ciclesonide nasal aerosol for perennial allergic rhinitis
Lightlake provides additional details on studies of nasal spray for eating disorders
Lightlake Therapeutics has provided additional details of recently announced Phase 2 trials of its naloxone nasal spray for binge eating disorder and for bulimia nervosa. Binge eating disorder trials have begun in Helsinki, with 138 patients randomly selected from more than 900 applicants taking either intranasal naloxone or a placebo nasal spray, says the … [Read more...] about Lightlake provides additional details on studies of nasal spray for eating disorders