OINDPnews


Aptar Pharma banner

Medical

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

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

Evoke Pharma’s intranasal metoclopramide program delayed

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

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