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Study shows intranasal ketamine can provide antidepressant effects within 24 hours

Researchers from the Icahn School of Medicine at Mount Sinai have demonstrated that a single 50 mg dose of a ketamine nasal spray could alleviate depressive symptoms in patients with treatment-resistant major depressive disorder within 24 hours. The authors conclude that, "This study provides the first controlled evidence for the rapid antidepressant effects of … [Read more...] about Study shows intranasal ketamine can provide antidepressant effects within 24 hours

GSK plans to make respiratory drugs more available in sub-Saharan Africa

As part of a planned five-year initiative to improve healthcare in Africa, GlaxoSmithKline has announced that it plans to make more of its existing drugs available in Africa and has specified the Ventolin albuterol inhaler as an example. The company's announcement also said that it would invest up to £100 million in its existing manufacturing facilities in Kenya and … [Read more...] about GSK plans to make respiratory drugs more available in sub-Saharan Africa

Mixed results in Phase 2 study of Arikayce for NTM lung infections

Insmed has announced that in a Phase 2 clinical trial of Arikayce (formerly Arikace) inhaled liposomal amikacin for nontuberculous mycobacterial (NTM) lung infections, the product failed to produce a statistically significant reduction in mycobacterial density; however, it did meet a secondary endpoint, with significantly more patients treated with Arikayce having … [Read more...] about Mixed results in Phase 2 study of Arikayce for NTM lung infections

Kamada initiates Phase 2 study of inhaled alpha-1 antitrypsin

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

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