Data to be presented at the upcoming annual meeting of The Endocrine Society show that healthy men treated with intranasal oxytocin consumed fewer calories and had reduced insulin sensitivity after use of the nasal spray. The randomized, placebo-controlled study, conducted by researchers from Harvard Medical School, involved 25 men, half of whom were normal weight and … [Read more...] about Study shows oxytocin nasal spray lowers calorie intake in men
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Adamis announces positive Phase 1 results for its fluticasone/salmeterol DPI
Adamis Pharmaceuticals has announced that data from a Phase 1 PK study its APC-5000 fluticasone/salmeterol DPI, a generic carrier-free version of Advair Diskus, show less systemic exposure to both components compared to Advair. The open-label study compared 3 inhalations of APC-5000 to 3 inhalations of Advair Diskus in 16 healthy subjects over 4 treatment … [Read more...] about Adamis announces positive Phase 1 results for its fluticasone/salmeterol DPI
Sunovion initiates Phase 3 program for glycopyrrolate inhalation solution
A Phase 3 trial program of Sunovion Pharmaceutical's SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD has begun enrolling patients, the company announced. The program includes three studies expected to enroll about 2,340 COPD patients. SUN-101 is delivered using PARI's eFlow nebulizer system and, if approved, would be the … [Read more...] about Sunovion initiates Phase 3 program for glycopyrrolate inhalation solution
Boehringer Ingelheim presents data from Phase 3 trials of tiotropium Respimat
Boehringer Ingelheim has presented data from five Phase 3 trials of tiotropium Respimat for the treatment of asthma at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The data come from two PrimoTinA-asthma trials (severe asthma), two MezzoTinA-asthma trials (moderate asthma), and a single GraziaTinA-asthma trial (mild asthma). … [Read more...] about Boehringer Ingelheim presents data from Phase 3 trials of tiotropium Respimat
Positive Phase 2 results for Savara’s AeroVanc
Savara Pharmaceuticals has announced positive results from a Phase 2 trial of its AeroVanc vancomycin DPI for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. In the 28-day trial, patients treated with AeroVanc had a statistically significant reduction in MRSA density in sputum compared to patients … [Read more...] about Positive Phase 2 results for Savara’s AeroVanc
PARI paying for nebulizer compressors for patients using Kitabis Pak
PARI has announced that it has begun supplying nebulizer compressors to patients using its new Kitabis Pak through a program called PARI Provide. Kitabis Pak, which includes generic tobramycin inhalation solution packaged with a PARI LC PLUS nebulizer, was approved by the FDA for the treatment P. aeruginosa infections in cystic fibrosis patients in December 2014. The … [Read more...] about PARI paying for nebulizer compressors for patients using Kitabis Pak
GSK and Theravance initiate Phase 3 study of triple combination inhaler
GlaxoSmithKline and Theravance have announced the beginning of the FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) Phase 3 study of a fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI in patients with COPD. The randomized double-blind study is expected to enroll approximately 1,800 patients. An earlier Phase 3 study … [Read more...] about GSK and Theravance initiate Phase 3 study of triple combination inhaler
Ultribro Breezhaler now available in Quebec
Novartis Pharmaceuticals Canada has announced the launch of the Ultibro Breezhaler indacaterol/glycopyrronium bromide DPI for the treatment of COPD in Quebec, the first province in Canada to reimburse the inhaler. The Régie de l’assurance maladie du Québec (RAMQ), which administers prescription drug insurance plans, has listed Ultribro Breezhaler as a “Médicament … [Read more...] about Ultribro Breezhaler now available in Quebec
Patient dosing begins in Phase 2a studies of AIR001 for the treatment of heart failure
Mast Therapeutics has announced that the first patients have been dosed in two Phase 2a studies of AIR001 sodium nitrite inhalation solution for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). A third Phase 2a study is due to start later this year. Mast acquired AIR001, which was being developed as a treatment for pulmonary … [Read more...] about Patient dosing begins in Phase 2a studies of AIR001 for the treatment of heart failure
Sanofi and Mannkind launch Afrezza in the US
Afrezza inhaled insulin is now available by prescription in the US, Sanofi and Mannkind Corporation have announced. The FDA approved the insulin DPI for the treatment of type 1 and type 2 diabetes in June 2014. In August 2014, Sanofi announced that it would pay Mannkind $150 million upfront and milestone payments of up to $775 million for an exclusive license for the … [Read more...] about Sanofi and Mannkind launch Afrezza in the US