Horizon Pharma said that the MONA (modified release prednisone for the treatment of nocturnal asthma) study is a two-stage, open-label, pilot trial assessing Lodotra’s treatment effect in patients with severe nocturnal asthma who require treatment with oral prednisone in addition to standard asthma therapy.
The primary endpoint of the study was the number of nocturnal awakenings due to asthma in treated patients. Secondary endpoints include asthma control questionnaire responses, asthma quality of life questionnaire responses and general safety.
Reportedly, data from five patients treated with 5 to 45mg of daily prednisone in accordance with the study protocol showed clinically relevant improvements in nocturnal symptoms, asthma control and asthma-related quality of life. The study showed that Lodotra chronotherapy was associated with an improvement in the mean number of nocturnal awakenings due to asthma, the primary endpoint of the trial, after patients switched from immediate release prednisone. The MONA study is expected to complete enrollment of patients in the third quarter of 2010.
Timothy Walbert, chairman, president and CEO of Horizon Pharma, said: “These pilot data suggest Lodotra may improve patients’ quality of life and the number of times they are awakened by asthma symptoms during the night.
“It has also been shown in clinical studies that Lodotra improve the signs and symptoms of rheumatoid arthritis in patients, an indication for which we anticipate submitting a new drug application to the FDA later this year.”