Issue link: https://www.e-digitaleditions.com/i/1073928
Recent news items on companies that develop, manufacture and provide products and services that support development of orally inhaled and nasal drug products. Inhalation February 2019 3 Industry news FDA approves Inbrija™ (inhaled levodopa powder) for Parkinson's disease A R D S L E Y , N E W Y O R K — A c o r d a T h e r a p e u t i c s , I n c . announced that the US Food and D r u g A d m i n i s t r a t i o n ( F D A ) a p p r o v e d I n b r i j a ™ ( i n h a l e d levodopa powder) for intermittent treatment of OFF episodes in people with Parkinson's disease treated with carbidopa/levodopa, making it the first and only inhaled levodopa for that purpose. Inbrija utilizes Acorda's Arcus ® platform for inhaled therapeutics. The Acorda news release explained that OFF episodes or OFF periods are defined as the return of Parkinson's symp- toms that result from low levels of dopamine between doses of oral car- bidopa/levodopa, the standard oral baseline Parkinson's treatment. e Michael J. Fox Foundation pro- vided funding for the early clinical development of Inbrija; patients had indicated OFF episodes were one of their most serious issues. Inbrija is expected to be available by prescrip- tion during the first quarter of 2019. FDA approves Teva's digital inhaler with built-in sensors JERUSALEM, ISRAEL—Teva Pharmaceutical Industries, Ltd. announced that the US Food and Drug Administration (FDA) has approved ProAir ® Digihaler™ (albuterol sulfate 117 mcg) inhala- tion powder, a digital inhaler with built-in sensors that connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. ProAir Digihaler is indicated for the treatment or prevention of bron- chospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older. ProAir Digihaler combines a breath-activated, multi-dose dry powder inhaler with albuterol, with a built-in electronic module and a companion mobile app. To gather real-world experience, it will be available in 2019 through a small number of "Early Experience" Pro- grams in partnership with health- care systems and in limited geogra- phies. A national US launch is planned for 2020. Verona begins Phase II trial for COPD DPI LONDON, UNITED KING- DOM—Pharma Times Online reported that Verona Pharma has announced the start of a Phase II clinical trial. It will evaluate the pharmacokinetic profile, efficacy and safety of a dry powder inhaler (DPI) formulation of RPL554 for use in patients with moderate to severe chronic obstructive pulmo- nary disease (COPD). RPL554 is a bronchodilator with anti-inflam- matory properties, currently in development for the maintenance treatment of COPD, cystic fibrosis and asthma. The two-part study with the new DPI formulation is being conducted at a site in the United States and will include approximately 36 COPD patients. Initial data is expected during the first half of 2019.