US FDA has approved TAP Pharmaceutical Products Inc's Prevacid (lansoprazole) for the short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 12 to 17 years, expanding its approved use in children to 1 to 17 years. Currently, Prevacid is the only proton pump inhibitor (PPI) approved for use by children as young as one year old, said a company release.
"Although people often think of heartburn related to acid reflux disease as an adult condition, many children and teens are affected by it," said Xavier Frapaise, vice president of research and development at TAP. "It is important that there are FDA-approved treatment options for teens who experience the often painful symptoms of acid reflux disease, such as heartburn," he added.
In an open-label, US multi-centre study, 87 adolescent patients (12 to 17 years of age) with symptomatic GERD were assigned to receive either Prevacid 15 mg or 30 mg once daily. At the beginning of the study, most patients (89 per cent) had mild to moderate overall GERD symptoms. Sixty-four patients had non-erosive GERD and were treated with Prevacid 15 mg daily for eight weeks, while 23 patients had erosive esophagitis and were treated with Prevacid 30 mg daily for eight to twelve weeks. Erosive esophagitis is a condition in which the lining of the esophagus has been damaged.
At the end of the study period, Prevacid was found to be safe and effective in treating patients with symptomatic GERD, including erosive esophagitis. Of 22 patients with erosive esophagitis evaluated, 95.5 per cent (21 patients) were healed after eight weeks of Prevacid treatment, which is similar to healing rates found in adults (92 per cent to 95 per cent).
"This approval is an important milestone for Prevacid in the treatment of acid reflux disease," said H. Thomas Watkins, president of TAP. "Prevacid is now available to help a larger group of patients, further reinforcing its leadership position in the PPI market," he said.
Prevacid offers a variety of administration options that can be used by children and teens. Prevacid for oral suspension is the only PPI available in this type of formulation, as well as the only PPI to offer an orally disintegrating tablet, Prevacid SoluTab. Prevacid SoluTab is a formulation that disintegrates quickly in the mouth, usually in less than 60 seconds, and can be taken with or without water. Prevacid SoluTab should not be chewed. Patients should simply place the tablet on the tongue and allow it to disintegrate until the particles can be swallowed, says the release.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott Laboratories and Takeda Chemical Industries Ltd, of Osaka, Japan. TAP also markets Lupron Depot (leuprolide acetate for depot suspension).