In Europe, Resolor is approved for use in women, and so the new variation extends the use of this treatment to male patients.
It is estimated that about 14% of the population is affected with chronic constipation, which is characterized by infrequent and difficult passage of stools over a prolonged period and includes a range of symptoms.
The company said that Resolor is a selective, high-affinity 5-HT4 receptor agonist, which helps to stimulate bowel motility.
The approval was based on a 12-week, multicentre, randomised, double-blind, placebo-controlled trial, which evaluated the efficacy, safety and tolerability of Resolor in 370 male patients with chronic constipation.
Results from this trial showed that a statistically significantly higher percentage of subjects in the Resolor group experienced normal bowel function, as assessed by an average of =3 spontaneous complete bowel movements (SCBMs) per week, compared with subjects in the placebo treatment group over the 12-week treatment period.