ME Newswire: First EffRx NDA Accepted for Filing by the FDA

Thursday, May 12, 2011

First EffRx NDA Accepted for Filing by the FDA

LAUSANNE, Switzerland - Thursday, May 12th 2011 [ME NewsWire]

(BUSINESS WIRE)-- 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.

Additional Intellectual Property: The company has also received notice of allowance from the US Patent and Trademark Office of additional patent claims protecting its proprietary formulation with respect to effervescent soluble formulations for all of the orally administered bisphosphonates.

About Effrx: EffRx is a privately held drug delivery technology company specializing in the utilization of proprietary effervescent technology to develop formulations that improve efficiency, compliance and convenience of existing prescription drugs.

For additional information please visit the EffRx web site at www.effrx.com