FDA accepts EffRx NDA for EX101 to treat osteoporosis

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May 12 2011

EffRx Pharmaceuticals SA, an Epalinges/Lausanne, Switzerland based drug delivery company announces that the New Drug Application (NDA) for the company's lead development program EX101 has been accepted for filing by the US Food and Drug Administration.

EX101 is a proprietary buffered effervescent dosage form of alendronate sodium administered once weekly for treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. The EX101 formulation is the first and only effervescent bisphosphonate alternative to tablets. EX101 has a pleasant taste of strawberry and is quickly and completely dissolved.

EffRx is in the process of securing partnership for distribution of EX101 in the USA and Japan. In the rest of the world EffRx has licensed commercialization of EX101 to Nycomed.

Source: EffRx Pharmaceuticals

Posted in: Medical Condition News | Pharmaceutical News

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