Rigel Pharmaceuticals' R343 inhaled SYK inhibitor has failed to meet primary or secondary endpoints in a Phase 2 study, the company said. As a result, Rigel will discontinue development of the product for the treatment of asthma. The company announced the launch of a Phase 2 study called SITAR ((SYK Inhibition for Treatment of Asthma with R343) in September … [Read more...] about Inhaled SYK inhibitor fails to meet endpoints in Phase 2 study
Medical
MannKind announces positive results from Phase 3 study of Afrezza
MannKind Corporation has announced that preliminary results from two Phase 3 clinical studies of Afrezza inhaled insulin met their primary endpoints. In a study in patients with Type 1 diabetes comparing Afrezza to insulin aspart, Afrezza was shown to be non-inferior in A1c level decreases and showed significant reductions in fasting blood glucose and significantly … [Read more...] about MannKind announces positive results from Phase 3 study of Afrezza
Dance Biopharm reports positive results from inhaled insulin study
According to Dance Biopharm, a 12-patient, randomized, semi-blinded Phase 1/2 pharmacokinetic study of its Adagio inhaled insulin in patients with Type 1 diabetes demonstrated the safety of the product and showed that it did not cause coughing. The Samba 01 study also showed consistent delivery of insulin, comparable to delivery by injection. Adagio is an inhalation … [Read more...] about Dance Biopharm reports positive results from inhaled insulin study
Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM
The US National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), has awarded a Small Business Initiative Research (SBIR) grant of approximately $278,000 to Aradigm to study the use of Aradigm’s Pulmaquin and Lipoquin inhaled liposomal ciprofloxacin products for the treatment of pulmonary non-tuberculous mycobacteria … [Read more...] about Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM
Intranasal aerosol proposed as treatment for snakebite
A group of researchers has published an article in Clinical Case Reports describing successful reversal of induced paralysis in a human volunteer after administration of intranasal aerosolized neostigmine, an anticholinesterase. According to the article, IV administration of anticholinesterases is the first-line treatment for neurotoxic snakebite when antivenom is … [Read more...] about Intranasal aerosol proposed as treatment for snakebite
Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays
Patient advocacy organization Allergy & Asthma Network Mothers of Asthmatics (AANMA) has released data from a survey of patients using intranasal corticosteroid sprays showing that 90% of the patients surveyed "said they prefer to rely on medical professionals to diagnose and manage their conditions." According to the organization, the survey also showed that more … [Read more...] about Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays
Pulmatrix initiates Phase 1B study of DPI for COPD
Pulmatrix has initiated a Phase 1B study of its PUR0200, an inhaled LAMA for the treatment of COPD, the company says. PUR0200 is a lactose-free formulation created using the company's iSPERSE particle engineering technology. Pulmatrix Chief Scientific Officer David Hava said, “PUR0200 has demonstrated outstanding performance in preclinical evaluation models of … [Read more...] about Pulmatrix initiates Phase 1B study of DPI for COPD
Activaero system used in new Ablynx Phase 1 studies of inhaled Nanobody for RSV
Activaero has announced that its FAVORITE (flow and volume regulated inhalation technology) system is being used for additional Phase 1 studies of Ablynx's Nanobody ALX-0171 for the treatment of respiratory syncytial virus (RSV). Results from a previous Phase 1 study of the drug were announced in September 2012. Ablynx President and CEO Edwin Moses recently … [Read more...] about Activaero system used in new Ablynx Phase 1 studies of inhaled Nanobody for RSV
Study shows feasibility of nasal dosing of diazepam during seizure
Acorda Therapeutics announced results from a clinical study of the pharmacokinetics, safety, and tolerability of its diazepam nasal spray for the treatment of cluster seizures in epilepsy patients at the recent International Congress of the International League Against Epilepsy (ILAE) and International Bureau for Epilepsy (IBE). Over the course of the study, 31 … [Read more...] about Study shows feasibility of nasal dosing of diazepam during seizure
Arikace meets primary endpoint in Phase 3 study
According to Insmed, a Phase 3 study of more than 300 cystic fibrosis patients has demonstrated the non-inferiority of once-daily Arikace inhaled liposomal amikacin to twice-daily TOBI tobramycin inhalation solution, meeting the study's primary endpoint. The company also announced that the FDA has granted Arikace Fast Track and Qualified Infectious Disease Product … [Read more...] about Arikace meets primary endpoint in Phase 3 study