Binosto
Generic name: alendronate
Treatment for: Osteoporosis
NDA Submitted for EX101
EffRx Pharmaceuticals SA Announces Submission of New Drug Application to FDA for Osteoporosis Treatment Targeting Increased Convenience for Patients
LAUSANNE, Switzerland--(BUSINESS WIRE)--Jan 10, 2011 - EffRx Pharmaceuticals SA, a Lausanne, Switzerland based drug delivery company announces the NDA submission of the company's lead project to the US Food and Drug Administration.
EX101 is a proprietary buffered effervescent dosage form of alendronate sodium administered once weekly for prevention and treatment of osteoporosis in postmenopausal women and incensement of 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 in half the water dose required for the administration of common bisphosphonate tablet treatments.
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.
"We are very pleased to have reached this stage of our lead product and are confident that EX101 will provide a convenient alternative to the patients with the aim of improving compliance rates, which is a common issue of today's available bisphosphonate tablet treatments", said Christer Rosén, CEO.
About EffRx Pharmaceuticals SA:
EffRx is a privately held drug delivery technology company specializing in the utilization of proprietary effervescent technology to develop formulations that improve compliance and convenience of existing prescription drugs.
For additional information please visit the EffRx web site at www.effrx.com
Contact: EffRx
Christer Rosén, Chairman and CEO
+41 79 963 66 00
crosen@effrx.com
or
Maj-Britt Kaltoft, COO
+41 79 963 66 05
mbkaltoft@effrx.com
Posted: January 2011
Related articles
- FDA Approves Binosto, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution - March 15, 2012
- First EffRx NDA Accepted for Filing by the FDA - May 11, 2011
Binosto (alendronate) FDA Approval History
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