A study published online in the journal Diabetes Care on December 17, 2015 demonstrated non-inferiority of intranasal glucagon to intramuscular glucagon for the treatment of insulin-induced hypoglycemia in type 1 diabetes patients. The study found that intranasal glucagon successfully raised plasma glucose to the target level within 30 minutes after dosing in 98.7% of … [Read more...] about Study finds intranasal glucagon effective for treatment of insulin-induced hypoglycemia
Medical
Phase 1 clinical trial of Acorda’s inhaled zolmitriptan gets underway
Enrollment has begun for a Phase 1 clinical study of Acorda Therapeutics' CVT-427 zolmitriptan DPI for the treatment of migraines, the company said. The single ascending dose study, which is expected to enroll 32 healthy adults, will assess the safety and tolerability of four doses of CVT-427 and will compare the pharmacokinetics of the inhaled drug to the … [Read more...] about Phase 1 clinical trial of Acorda’s inhaled zolmitriptan gets underway
Sumatriptan nasal spray shortage expected to last until February 2016
According to the FDA, GlaxoSmithKline has reported that 20 mg and 5 mg dosages of its Imitrex nasal spray for the treatment of migraine headaches will be unavailable until February 2016 due to an API shortage. The shortage, which was reported to the FDA on November 20, 2015, affects both dosages of an authorized generic sumatriptan nasal spray distributed by Sandoz … [Read more...] about Sumatriptan nasal spray shortage expected to last until February 2016
Phase 3 study shows indacaterol/glycopyrronium reduces COPD exacerbations better than Advair
Novartis today has announced that the Phase 3 FLAME study demonstrated that the Utibron Neohaler (Ultibro Breezhaler) indacaterol/glycopyrronium DPI reduced the rate of COPD exacerbations more effectively than the Advair (Seretide) fluticasone/salmeterol DPI over a 52-week period. FLAME involved over 3,360 COPD patients in 43 countries and was designed to demonstrate … [Read more...] about Phase 3 study shows indacaterol/glycopyrronium reduces COPD exacerbations better than Advair
Positive top-line results from several Teva Phase 3 DPI studies
Teva Pharmaceutical Industries has announced top-line results from three Phase 3 clinical studies of its generic fluticasone propionate/salmeterol DPI and a fluticasone propionate monotherapy DPI for the treatment of asthma. The company said that all of the studies met their primary endpoints and that it plans to submit regulatory applications to the FDA for both … [Read more...] about Positive top-line results from several Teva Phase 3 DPI studies
Turing Pharmaceuticals says it will initiate a Phase 1 trial of intranasal ketamine in early 2016
Turing Pharmaceuticals, which is the subject of several investigations into its pricing strategies, has said that it plans to begin a Phase 1 trial of its TUR-002 intranasal ketamine in the first quarter of 2016. The company said that is developing TUR-002 for both post-traumatic stress disorder (PTSD) and major depressive disorder. Turing CEO Martin Shkreli said, … [Read more...] about Turing Pharmaceuticals says it will initiate a Phase 1 trial of intranasal ketamine in early 2016
Discovery Labs announces additional Phase 2a data, says it is ready to advance Aerosurf to Phase 2b
Discovery Laboratories has announced additional data from its Phase 2a trials of Aerosurf aerosolized surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants 29 to 34 week gestational age. that are receiving nasal continuous positive airway pressure (nCPAP). The company said that the data are "encouraging" and demonstrate that Aerosurf … [Read more...] about Discovery Labs announces additional Phase 2a data, says it is ready to advance Aerosurf to Phase 2b
Discovery Labs provides update on Aerosurf development
Discovery Laboratories has provided an update on its clinical development program for Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants. In March 2015, the company announced that it was restructuring to focus all its attention on Aerosurf. According to Discovery Labs, enrollment in a Phase 2a expansion … [Read more...] about Discovery Labs provides update on Aerosurf development
Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto
Acerus (formerly Trimel) has announced that it will pursue development of its Tefina nasal testosterone for the treatment of hypoactive sexual desire disorder (HSDD) instead of for female orgasmic disorder (FOD). In May 2014, the company announced positive results from a Phase 2 study of Tefina for FOD. The decision to switch course came after meeting with the FDA … [Read more...] about Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto
GSK announces that Advair Diskus meets primary endpoint in safety study
GlaxoSmithKline has announced results from the 26-week AUSTRI postmarketing study comparing the safety of Advair Diskus fluticasone propionate/salmeterol DPI to fluticasone propionate monotherapy for the treatment of asthma. According to GSK, the study demonstrated that Advair Diskus was non-inferior to FP at three different dosage strengths for the risk of serious … [Read more...] about GSK announces that Advair Diskus meets primary endpoint in safety study