EffRx submits EX101 NDA for osteoporosis treatment to FDA

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.

“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”

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.