Medical

Theravance has begun a dose ranging Phase 2b study of its TD-4208 inhalation solution in approximately 60 patients with moderate to severe COPD. According to the company, "The goal of Theravance's LAMA program for respiratory disease is to develop a once-daily inhaled medicine in a nebulizer that offers improved efficacy and tolerability relative to current therapies … [Read more...] about Theravance initiates Phase 2b study of investigational LAMA

A study by scientists from the UK Defence Science and Technology Laboratory (Dstl) showed that a single dose of Aradigm's Lipoquin liposomal ciprofloxacin administered through the nose fully protected mice exposed to an aerosolized "lethal dose" of Yersinia pestis. Inhaled aerosolized Lipoquin provided 70% protection, while untreated mice and those given a single dose … [Read more...] about Study shows Aradigm’s Lipoquin protects against plague in mice

The FDA has issued a warning to parents and health care professionals after receiving reports of accidental ingestion of nasal sprays and eye drops by children. According to the agency, the decongestant nasal sprays reported to have sickened children 5 years and younger who swallowed them had the active ingredients tetrahydrozoline or oxymetazoline. The warning … [Read more...] about FDA issues warning on ingestion of nasal sprays

According to Pearl Therapeutics, a randomized, double-blind, dose-ranging Phase 2b study of its PT003 formoterol fumarate (FF)/glycopyrrolate (GP) MDI for the treatment of moderate-to-severe COPD in more than a thousand patients showed that several doses of PT003 demonstrated superior bronchodilation compared to each of the components and to tiotropium. The … [Read more...] about Pearl completes Phase 2 program for PT003

According to Chiesi Group, a Phase 1 trial of its inhaled phosphodiesterase 4 (PDE4) inhibitor for the treatment of lung diseases such as COPD and asthma demonstrated that the drug, known as CHF 6001, was well tolerated in healthy volunteers at doses of up to 2000 µg for up to 7 days. In vitro and animal studies have shown that CHF 6001 is more potent than … [Read more...] about Chiesi announces positive Phase 1 results for its inhaled PDE4 inhibitor

An article posted on October 4, 2012 on the BMJ publication Drug and Therapeutics Bulletin article asks, "who needs teaching?" when it comes to inhaler technique. The article points out that an overwhelming number of health professionals have a poor understanding of how to use inhalers and are therefore in no position to teach patients how to use the devices. The … [Read more...] about Drug and Therapeutics Bulletin article warns that health professionals do not understand how to use inhalers properly

MannKind Corporation says that it has completed recruitment of patients for two Phase 3 studies of Afrezza inhaled insulin. One of the studies will assess HbA1c levels in Type 1 diabetes patients using either injected rapid-acting insulin, Afrezza delivered with the MedTone inhaler, or Afrezza delivered by MannKind's next generation inhaler. The second study involves … [Read more...] about MannKind completes patient recruitment for two Afrezza studies

OptiNose has announced results of a randomized, single-dose, four-way cross-over PK study demonstrating that 20% less of its intranasal dry powder sumatriptan product delivered into the nose than Imitrex nasal spray resulted in over 60% more sumatriptan in the blood in the first 15 minutes. The 16 mg dose of the Optinose product also resulted in over 30% more in … [Read more...] about Study shows better absorption for dry powder intranasal sumatriptan than nasal or oral Imitrex

MicroDose Therapeutx has completed the Phase 1 clinical program for its inhaled antiviral fusion inhibitor MDT-637 for the treatment of respiratory syncytial virus infection and plans to present data from the three studies at the upcoming International Respiratory Syncytial Virus Symposium. The company announced completion of the first two studies in April 2012. … [Read more...] about Microdose announces completion of Phase 1 studies for inhaled RSV treatment