With fewer treatment options available for childhood diarrhea, Samjin Pharmaceutical (005500) has eased the age limit on its antidiarrheal powder Hidrasec and made the drug easier to take. The change is expected to widen treatment choices for children and adolescents at a time when demand for alternative therapies has risen after another antidiarrheal lost its pediatric indication.
Samjin Pharmaceutical said on the 13th that the Ministry of Food and Drug Safety had approved revisions to the labeling of Hidrasec powder, whose active ingredient is racecadotril, covering both the eligible age range and the dosing instructions. The approval was granted on Sept. 23.
The revision removes the upper limit of the previous range, which covered children from 3 months of age to under 12 years. Patients aged 3 months and older, including adolescents, are now eligible for the prescription.
The dosing instructions have also been simplified into sachets based on body weight. Under the revised regimen, patients weighing less than 9 kilograms take one 10-milligram sachet; those from 9 kilograms to under 13 kilograms take two 10-milligram sachets; those from 13 kilograms to 27 kilograms take one 30-milligram sachet; and those above 27 kilograms take two 30-milligram sachets, each three times a day. The drug remains in powder form, which can be mixed with water, infant formula, milk or food.
The labeling change comes amid a shift in the market for pediatric diarrhea treatments. In July, the ministry removed the indication for acute diarrhea in children aged 24 months and older from products containing dioctahedral smectite, after concerns were raised about lead content. Demand for alternative treatments subsequently rose, and Hidrasec powder experienced a temporary supply disruption. Both the 10-milligram and 30-milligram products are now being supplied normally.
"This labeling change expands the range of patients who can be prescribed the drug and makes it easier to take," said Kim Sang-jin, president of Samjin Pharmaceutical. "We will do our utmost to maintain a stable supply of Hidrasec powder so that no gap emerges in the treatment of diarrhea in children."