Evoke Pharma has announced that slower than expected enrollment in a Phase 3 clinical trial of its EVK-001 metoclopramide nasal spray for the treatment of diabetic gastroparesis in women will result in delayed completion of the development program and potential NDA submission. The company says that it now expects enrollment to be complete in the second half of 2015 … [Read more...] about Evoke Pharma’s intranasal metoclopramide program delayed
Medical
Study finds that use of triamcinolone nasal spray affects children’s growth
A study published online in Pediatrics finds that children using a triamcinolone nasal spray for allergic rhinitis grew on average 0.44 cm/year less than children using a placebo nasal spray (5.65 cm/year compared to 6.09 cm/year). The year-long study was conducted according to the 2007 FDA guidance on Orally Inhaled and Intranasal Corticosteroids: Evaluation of the … [Read more...] about Study finds that use of triamcinolone nasal spray affects children’s growth
Alexza announces initiation of Phase 2a study of inhaled alprazolam
According to Alexza Pharmaceuticals, a Phase 2a study of AZ-002 Staccato alprazolam for the treatment of epilepsy patients with acute repetitive seizures has been initiated. The study will take place in-clinic, though AZ-002 is being developed for home use to limit the occurrence of additional seizures after the patient has experienced one seizure and therefore to … [Read more...] about Alexza announces initiation of Phase 2a study of inhaled alprazolam
Study shows greatly improved compliance for children using SmartTrack device
According to Nexus6, a study conducted in New Zealand has shown that 84% of children using the Smartinhaler SmartTrack device, which provides both audio and visual reminders, used their inhalers as prescribed compared to 30% using MDIs without an audio reminder. Fewer than 10% of the children using SmartTrack required rescue medication compared to more than 17% of the … [Read more...] about Study shows greatly improved compliance for children using SmartTrack device
First patients dosed in Phase 1/2 trial of Verona’s RPL554
According to Verona Pharma a Phase 1/2 trial of its RPL554 inhaled PDE3/4 inhibitor for the treatment of COPD has gotten underway with dosing of the first subjects. Plans are for recruitment of up to 120 healthy volunteers and COPD patients in total, with results expected by the end of the year. The trial is testing a new formulation of RPL554 "suitable for … [Read more...] about First patients dosed in Phase 1/2 trial of Verona’s RPL554
Study shows intranasal insulin detemir improves short term memory in Alzheimer’s patients
Researchers at Wake Forest Baptist Medical Center have announced results of a study in which 60 patients with amnesic mild cognitive impairment or mild to moderate Alzheimer's dementia received one of two doses of an insulin detemir nasal spray or placebo for 21 days. According to the authors, patients receiving the higher dose (40 IU), demonstrated significant … [Read more...] about Study shows intranasal insulin detemir improves short term memory in Alzheimer’s patients
Novartis announces NDA submissions for QVA149 and NVA237 DPIs
Novartis has announced that it submitted New Drug Applications to the FDA for both the QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide DPIs in the fourth quarter of 2014. Both inhalers are meant for the treatment of COPD. In early 2012, the company said that it planned to submit marketing applications for the two products in the US by the … [Read more...] about Novartis announces NDA submissions for QVA149 and NVA237 DPIs
Insmed provides update on its pipeline
According to Insmed, the company has filed an MAA for its Arikayce liposomal amikacin for inhalation, and it has been informed by the EMA that the only remaining issue, a review of the Pediatric Investigation Plan (PIP) by the agency's Pediatric Committee, should be finished by the first quarter of 2015. A trial of Arikayce for the treatment of resistant … [Read more...] about Insmed provides update on its pipeline
GSK to change color of Relvar Ellipta
GSK has announced that it will change the color of the Relvar Ellipta fluticasone/vilanterol DPI starting in January 2015. The company said that it will remove the color blue from the inhaler and its packaging and will change the mouthpiece cover and packaging to yellow. Pharmacists had expressed concerns that patients would be confused because the color blue has been … [Read more...] about GSK to change color of Relvar Ellipta
Acorda announces start of Phase 3 study for inhaled L-dopa
Acorda Therapeutics has announced the enrollment of the first patient in a Phase 3 study of CVT-301 inhaled L-dopa for the treatment of OFF episodes in Parkinson’s disease (PD). The study is expected to enroll about 345 patients. CVT-301 was initially developed by Civitas Therapeutics which was acquired by Acorda earlier this year. Acorda Chief Medical Officer … [Read more...] about Acorda announces start of Phase 3 study for inhaled L-dopa