Almirall and Forest Laboratories have announced that Phase 3 studies of inhaled aclidinium and Phase 2b studies of an inhaled aclidinium/formoterol combination both met their primary endpoints. As a result, the companies expect to submit regulatory applications for an aclidinium DPI for the treatment of COPD in the US and Europe in mid-2011 and will begin Phase 3 … [Read more...] about Positive results for aclidinium alone and in combination with formoterol
Medical
Ritedose recalls albuterol inhalation solution vials in US
Contract manufacturer Ritedose has voluntarily recalled unit dose vials of albuterol inhalation solution due to mislabeling. The single dose vials contain a 2.5 mg/3 mL solution but are labeled as 0.5 mg/3 mL. The product was distributed across the United States and in Puerto Rico. Read the company's press release. … [Read more...] about Ritedose recalls albuterol inhalation solution vials in US
Inspire’s CF drug fails Phase 3 trial
The results from Inspire Pharmaceuticals' second Phase 3 trial of denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis show that the drug failed to meet its primary endpoint, change in FEV from baseline. Denufosol is an ion channel regulator. A previous Phase 3 trial had produced significant change in FEV from baseline, and the company says … [Read more...] about Inspire’s CF drug fails Phase 3 trial
MAP completes final Levadex trial
According to MAP Pharmaceuticals, it has completed a year-long open label safety trial of its Levadex inhaled dihydroergotamine, the final step in its development program for the product. More than 250 patients completed the 12-month study. The company plans to submit an NDA for Levadex in the first half of 2011. Read the company's press release. … [Read more...] about MAP completes final Levadex trial
Pearl announces positive Phase 2b results for COPD drug
According to Pearl Therapeutics, a Phase 2b study has demonstrated that its PT003 glycopyrrolate/formoterol combination MDI provides superior bronchodilation compared to placebo, compared to its individual components, and compared to tiotropium. The trial involved patients with moderate to very severe COPD. Read the company's press release. … [Read more...] about Pearl announces positive Phase 2b results for COPD drug
Verona announces successful proof of concept tests of lead product
Verona Pharma, which has been looking for a partner for its lead product RPL554, an inhaled phosphodiesterase 3 and phosphodiesterase 4 inhibitor for the treatment of asthma, COPD, and allergic rhinitis, announced that it has performed successful delivery tests by nebulizer, MDI, and DPI. Read the company's press release. … [Read more...] about Verona announces successful proof of concept tests of lead product
New asthma cure — quit Facebook?
An article published in The Lancet on November 20, 2010 describes the case of a teen-aged boy who appeared to suffer from asthma exacerbations linked to emotional distress caused by his use of Facebook. His asthma had previously been well controlled with ICS and Singulair; but after he was dumped by his girlfriend, visits to her profile page coincided with measurable … [Read more...] about New asthma cure — quit Facebook?
Clinicians told they overprescribe combination inhalers
Researchers from the Medco Research Institute presented data at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) showing that clinicians are prescribing ICS/LABA combination treatment for two thirds of patients with mild persistent asthma and that the combination therapy has no benefit for these patients compared to ICS … [Read more...] about Clinicians told they overprescribe combination inhalers
Mannkind announces positive Phase 3 results while facing clinical trial fraud accusations
Having recently announced that it stands by its clinical trials after a former executive filed suit against the company for retaliatory termination after he raised concerns about the validity of studies conducted in Russia and Bulgaria, Mannkind has released new data from a Phase 3 bioequivalence study of its Afrezza inhaled insulin. The new data concern the … [Read more...] about Mannkind announces positive Phase 3 results while facing clinical trial fraud accusations
Teva announces positive Phase 3 results for Qnaze nasal spray
A Phase 3 study of the Qnaze beclamethasone nasal spray from Teva has demonstrated that the product produced significant symptom relief compared to placebo, according to a Teva presentation at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI). Qnaze is a "dry" HFA intranasal formulation delivered by MDI and … [Read more...] about Teva announces positive Phase 3 results for Qnaze nasal spray