Israeli pharmaceutical company Kamada has initiated a US Phase 2 trial of its inhaled alpha-1 antitrypsin (AAT) for the treatment of AAT deficiency, also known as inherited emphysema. The company also announced a delay in reporting results from a Phase 2/3 study of the product in Europe and Canada and said that it now expects to report top-line results from that … [Read more...] about Kamada initiates Phase 2 study of inhaled alpha-1 antitrypsin
Medical
GSK announces that Phase 3 study results show Anoro Ellipta improves lung function more than Advair Diskus
GSK and Theravance have announced that results from three phase 3 studies comparing the Anoro Ellipta umeclidinium/vilanterol DPI to Advair and Seretide Diskus in COPD patients show greater improvement in lung function for patients treated with Anoro Ellipta. The three randomized, double-blind, double-dummy, parallel group studies involved a total of about 2,100 … [Read more...] about GSK announces that Phase 3 study results show Anoro Ellipta improves lung function more than Advair Diskus
Fresenius Kabi launches 4 ml vials of acetylcysteine inhalation solution
Fresenius Kabi USA has announced the immediate availability of 4 ml vials of 20% acetylcysteine solution for inhalation. The company has offered 10 ml vials since 2012 and 30 ml vials since 2013. Acetylcysteine solution for inhalation, a mucolytic agent, had been in short supply in the US since 2011. Several manufacturers, including Ben Venue and American … [Read more...] about Fresenius Kabi launches 4 ml vials of acetylcysteine inhalation solution
St. Renatus completes Phase 3 studies on intranasal dental anesthetic
St. Renatus has announced the completion of adult and pediatric Phase 3 clinical studies of its nasal mist dental anesthesia and says that it is now working on data analysis with the goal of submitting an NDA for the product in 2014. The nasal anesthetic numbs the upper teeth without affecting the patient's lips or face. St. Renatus CEO Steve Merrick commented, "We … [Read more...] about St. Renatus completes Phase 3 studies on intranasal dental anesthetic
AANMA objects to Primatene HFA
Tonya Winders, President and CEO of Allergy & Asthma Network Mothers of Asthmatics (AANMA) will speak in opposition to the approval of Primatene HFA at the upcoming joint meeting of the FDA's Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Committee, the organization has announced. The AANMA contends that Armstrong's OTC Primatene HFA … [Read more...] about AANMA objects to Primatene HFA
Insmed provides update on ongoing study of Arikace for P. aeruginosa infections in CF patients
Insmed says that it is pleased with results from its ongoing CLEAR-110 extension study of Arikace inhaled liposomal amikacin for the treatment of P. aeruginosa infections in cystic fibrosis patients. Data from 98 patients who completed the first year of the two-year study showed that Arikace was well tolerated, the company said, and patients experienced continued … [Read more...] about Insmed provides update on ongoing study of Arikace for P. aeruginosa infections in CF patients
Another recall of acetylcysteine inhalation solution
Ben Venue Laboratories has voluntarily recalled a single lot of 30 ml vials of acetylcysteine 10% inhalation solution due to a glass particle visible in one of the vials. The recall affects lot #2005479 which has an expiration date of March 2014. According to Ben Venue, "There have been no complaints or adverse events related to a piece of glass in vials of this … [Read more...] about Another recall of acetylcysteine inhalation solution
Chattem launches Nasacort Allergy 24HR nasal spray in US
Sanofi US consumer healthcare division Chattem has announced that Nasacort Allergy 24HR Nasal Spray is now available over the counter in the United States. The FDA approved the triamcinolone acetonide nasal spray as an OTC treatment for allergies in October 2013. Chattem CEO Zan Guerry commented, “Now that Nasacort Allergy 24HR is available over-the-counter, the … [Read more...] about Chattem launches Nasacort Allergy 24HR nasal spray in US
Phase 2 study of Prosonix drug-only glycopyrronium MDI produces positive results
Prosonix has announced that a Phase 2 clinical study of its PSX1002 glycopyrronium bromide MDI in 37 COPD patients demonstrated statistically significant improvement in lung function compared to placebo for a range of doses. PSX1002 is a drug-only suspension formulation created using Prosonix's proprietary particle engineering technology. The study also showed … [Read more...] about Phase 2 study of Prosonix drug-only glycopyrronium MDI produces positive results
Positive Phase 2b results for Evoke intranasal gastroparesis drug
Evoke Pharma has published a Phase 2b study demonstrating superior efficacy of intranasal metoclopramide compared to oral metoclopramide for the management of diabetic gastroparesis symptoms. The study appears in an upcoming issue of Neurogastroenterology & Motility and appears online ahead of publication. The six-week open-label, parallel design study involved 89 … [Read more...] about Positive Phase 2b results for Evoke intranasal gastroparesis drug