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Asthma Pill Shows Promise in Small Clinical Trial
The first new asthma pill in decades has produced promising results in a small clinical study, potentially paving the way for another treatment option for patients by the end of the decade, according to a Reuters report.
Researchers in the United Kingdom hypothesized that fevipiprant (Novartis), a prostaglandin D2 receptor 2 antagonist, might reduce eosinophilic airway inflammation in patients with moderate-to-severe eosinophilic asthma. They conducted a single-center, randomized, double-blind, parallel-group, placebo-controlled trial at Glenfield Hospital in Leicester. A total of 61 patients with persistent, moderate-to-severe asthma and an elevated sputum eosinophil count (greater than or equal to 2%) were enrolled in the study.
After a two-week, single-blind, placebo run-in period, the patients were randomly assigned to receive either oral fevipiprant (225 mg twice daily; n = 30) or placebo (n = 31) for 12 weeks. This was followed by a six-week single-blind placebo washout period. The trial’s primary outcome was the change in the sputum eosinophil percentage from baseline to 12 weeks after treatment.
Three patients in the fevipiprant group and four patients in the placebo group withdrew because of asthma exacerbations. Between baseline and 12 weeks after treatment, the sputum eosinophil percentage decreased from a geometric mean of 5.4% to 1.1% in the fevipiprant group and from 4.6% to 3·9% in the placebo group. Compared with baseline, the mean sputum eosinophil percentage was reduced by 4.5 times in the fevipiprant group and by 1.3 times in the placebo group (difference between groups: 3.5 times; P = 0.0014).
Larger and longer studies are now needed to prove that the twice-daily pill can also reduce severe asthma exacerbations, according to the authors. Novartis believes that fevipiprant could be filed for FDA approval in around 2019.
According to Reuters, the latest research, published in Lancet Respiratory Medicine, comes at a time of considerable innovation in asthma care, with the recent launch of new injectable drugs for severe asthma that also target eosinophils. At the same time, many drug makers are developing improved asthma inhalers, including “smart” devices with sensors that monitor use.
Sources: Reuters; August 6, 2016; and Lancet Respiratory Medicine; August 5, 2016.