MER 103 is an enteric-coated tablet of Fosamax and GIPET, Merrion’s platform technology which increases drug absorption.
The study confirmed several important improvements for patient convenience and compliance relating to the administration of Fosamax developed by Merck, the leading bisphosphonate for osteoporosis.
Merrion said that the study addressed two major limitations of oral bisphosphonates, showing improved bioavailability and the elimination of the morning dosing ritual. Compliance with the morning dosing ritual is a major issue in treating osteoporosis.
The study was conducted in postmenopausal women and compared the absorption of a 6mg dose of MER 103 administered under three different conditions: in the fasted state, together with a high fat meal, and at bedtime, against a 35mg dose of Fosamax.
Subjects who received 6mg MER 103 after an overnight fast absorbed approximately twelve times more alendronate on a dose adjusted basis than when they received 35mg of Fosamax. In practice, these data indicate that a 6mg weekly dose of MER 103 will be bioequivalent to a 70mg weekly dose of Fosamax.
Those who received MER 103 at bedtime, approximately 4 hours after the evening meal, absorbed the same amount of alendronate as they did when taking the drug after an overnight fast. The study also showed that co-administration with food reduced the absorption of MER 103, although the percent drug absorbed was still greater than for the Fosamax dose.