Depomed, Inc., a specialty pharmaceutical company, has completed phase I clinical trial to evaluate the delivery and absorption of a compound currently used to treat gastroesophageal reflux disease (GERD).
"This is an exciting new programme which we believe is ready to advance into later stage clinical development," said Bret Berner, Ph.D., vice president, product development and chief scientific officer. "GERD is a highly prevalent gastrointestinal disorder which affects millions of people. We believe that our drug delivery approach for this compound may specifically address nocturnal acid breakthrough, a condition which current agents do not adequately address."
The phase I clinical trial was conducted in healthy volunteers to evaluate specific pharmacokinetic and absorption behaviour of the drug compound once it is in the gastrointestinal tract. The results demonstrated both an absorption and bioavailability profile, which provided clear criteria to design Depomed's controlled release formulation of the drug to potentially facilitate improved therapy.
John Fara, Ph.D., chairman, president and chief executive officer of Depomed, commented, "This programme is aligned with our strategic criteria for markets with large unmet needs that, if addressed, will differentiate our product with patients and physicians as well as with the managed care organizations that look for pharmacoeconomic benefits. The market size is tremendous with current sales of GERD treatments estimated at over $10 billion per year. We intend to begin a phase IIa clinical trial for the GERD program later this fall. Importantly, this program has been underway for some time and is covered under our budget for 2006."
Gastroesophageal reflux disease (GERD) is a reflux of gastroduodenal contents into the esophagus, resulting in symptoms and/or injury. The disease is common, with an estimated lifetime prevalence of 25 to 35 per cent in the US population. Depomed is exploring the possibility of developing an oral, controlled release GERD therapy that may specifically address nocturnal acid breakthrough.