Taro announced that the Food and Drug Administration (FDA) has approved Keveyis (dichlorphenamide) tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis. Keveyis is the first prescription drug approved for the treatment of primary periodic paralysis.
Keveyis, an oral carbonic anhydrase inhibitor, was studied in two clinical studies: Study 1 and Study 2. Study 1 (n=65) was a nine-week, double blind, placebo-controlled multicenter study that assessed the average number of self-reported attacks of muscle weakness per week over the final eight weeks of the trial. None of the patients randomized to Keveyis in both substudies reached the endpoint of acute worsening vs. patients randomized to placebo.
Study 2 (n=73) was a 35-week, double-blind, placebo-controlled, multicenter, two-period crossover study that assessed the incidence of acute intolerable worsening (based on attack frequency or severity) necessitating withdrawal and the average number of self-reported attacks of muscle weakness per week. The study found that acute intolerable worsening was seen in two patients that received Keveyis vs. 11 patients on placebo (P=0.02). In addition, patient treated with Keveyis had 2.3 fewer attacks per week than those on placebo (P=0.006).
Keveyis will be available as 50mg tablets in 100-count bottles in the third quarter of 2015.
For more information call (866) 923-4914 or visit Keveyis.com.