FDA approves first effervescent osteoporosis treatment in a buffered solution

FDA has approved alendronate sodium (Binosto, EffRx Pharmaceuticals) effervescent tablets, the first effervescent osteoporosis treatment in a buffered solution.

Binosto is previously known as EX101, for the treatment of osteoporosis in postmenopausal women, and as a treatment to increase bone mass in men with osteoporosis. Binosto will be commercially available in the United States in the third quarter of 2012.

Binosto offers those patients who have difficulty with tablets the proven fracture risk reduction of alendronate in an easy-to-swallow buffered solution, Christer Rosen, chairman and CEO of EffRx, said in a company press release.

Osteoporosis affects more than 200 million people in the 7 major markets and the global market is estimated to be $10 billion and growing, especially in the emerging markets.

Binosto is a once-weekly, strawberry-flavored effervescent tablet containing alendronate 70 mg that rapidly dissolves in half a glass (4 oz.) of plain room temperature water to make a buffered solution. It is available in packs of 4 and 12 tablets.

Binosto was developed by EffRx based on an agreement with Merck & Co, 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.