FDA Approves Binosto
FDA Approves Binosto, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution
FREIENBACH, Switzerland, March 14, 2012 /PRNewswire/ -- EffRx Pharmaceuticals SA today announced that the U.S. Food and Drug Administration (FDA) has approved Binosto (alendronate sodium) Effervescent Tablets, previously known as EX101, for the treatment of osteoporosis in postmenopausal women, and as a treatment to increase bone mass in men with osteoporosis. EffRx anticipates that Binosto will be commercially available in the United States in the third quarter of 2012.
Christer Rosen, Chairman & CEO of EffRx states: "We are very pleased to receive this approval from the FDA. Binosto is a breakthrough innovation for the treatment of osteoporosis, offering those patients who have difficulty with tablets the proven fracture risk reduction of alendronate in a pleasant tasting and easy-to-swallow buffered solution."
Osteoporosis affects more than 200 million people in the 7 major markets and the global market is estimated to be USD10 billion and growing, especially in the emerging markets. Binosto is an innovative treatment option that can assure physicians that they are providing a proven efficacious therapy for those patients who have difficulty with tablets. A Harris Interactive Poll concluded that up to 40% of American adults have difficulties with swallowing tablets.
Binosto is a once weekly, strawberry flavored effervescent tablet containing alendronate 70mg that rapidly dissolves in half a glass (4oz) of plain room temperature water to make a buffered solution. Binosto is available in packs of 4 and 12 tablets.
Binosto was developed by EffRx based on an agreement with Merck & Co, Inc. granting EffRx the worldwide rights to all effervescent and related patents of Fosamax (alendronate). Patents have been granted to EffRx providing exclusivity for Binosto through February 2023. Additional patents are pending.
EffRx Pharmaceuticals SA is a drug delivery company based in Freienbach, Switzerland. EffRx specializes in improving existing high volume pharmaceutical products by utilizing its novel techniques in different effervescent executions. The primary focus of EffRx is in metabolic bone disease, oncology supportive care, pediatric medications and support to larger companies in Life Cycle Management.
EffRx has a licensing agreement with Nycomed, a Takeda Company, for development, manufacturing and commercialization of EffRx patented effervescent alendronate for the treatment of osteoporosis in all territories in the world except USA, Canada and Japan.
SOURCE EffRx Pharmaceuticals
Posted: March 2012
- First EffRx NDA Accepted for Filing by the FDA - May 11, 2011
- EffRx Pharmaceuticals SA Announces Submission of New Drug Application to FDA for Osteoporosis Treatment Targeting Increased Convenience for Patients - January 10, 2011