Almerol™ is a highly innovative dosage form of alendronate (Fosamax®, Merck and other trademarks), which uses Merrion's absorption enhancing technology (GIPET®) to provide significant benefits to patients and medical practitioners.
Bisphosphonates are the most widely used therapy for osteoporosis a $7bn market in 2009.
Once-weekly oral formulations of Alendronate dominate usage at present.
A key issue in this marketplace is adherence to therapy. A large patient survey by the International Osteoporosis Foundation has shown that almost 60% of patients dosed weekly discontinue therapy within the first year, and that side effects and the complexity of dosing are the major patient reasons for discontinuing treatment.
Existing products, like Fosamax®, must be taken at least 30 minutes before the first food, beverage, or medication of the day with plain water only. The fasted bioavailability of Fosamax® is 0.6% and it is negligible if taken with food. Patients are cautioned to sit or stand upright for 30 minutes after taking their medication in order to reduce the potential for oesophageal irritation, and may have to discontinue therapy if they suffer reflux.
The patented Almerol™ formulation features GIPET® technology substantially improve bioavailability and enteric coating to release the drug in the small intestine.
Several clinical Phase I/II studies have demonstrated successfully the clinical proof of concept for the product.
The Almerol™ formulation has demonstrated its potential to improve patient experience and reduce side effects by:
Clinical Data for Almerol™ - presented at The North American Menopause Society Annual Meeting October 2007.