Novoteris recently announced that the FDA has granted orphan drug designation for inhaled nitric oxide gas as a treatment for Cystic Fibrosis.
‘ “The FDA’s decision to grant nitric oxide orphan drug designation for this indication signifies an important step for Novoteris,” stated Alex Stenzler, President of Novoteris.’
‘Chris Miller, PhD, Chief Science Advisor, noted that, “The results from our pilot trial demonstrated more than a 15% increase in lung function following two weeks of therapy and we anticipate that we will be able to demonstrate similar outcomes in our Phase II trials.” ’
Additional Information provided by Alex Stenzler
The pilot study was a small single center trial in Germany. The data was presented at the European Cystic Fibrosis meeting in Lisbon this year. The FEV1 improvement was 17.3 ±8.9% (relative) from baseline and 8.8 ±4.9% (absolute) from baseline (p=0.012). Two phase II trials are planned for 2014, one in Europe and one in North America.
About Nitric Oxide
Nitric oxide is produced by the human body and is involved in every organ system including defense against micro-organisms. Nitric oxide therapy has been shown to be an effective antimicrobial agent against many microbes including drug resistant strains. Exhaled nitric oxide levels are commonly low in patients with Cystic Fibrosis.
Sources: Novoteris Nitric Oxide Press Release and Alex Stenzler, president of Novoteris.