First EffRx NDA accepted for filing by the FDA...

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. 

About Alendronate : Alendronic acid or alendronate sodium ( sold as Fosamax by Merck) is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 U and 5600 U, under the name Fosamax+D). Merck's U.S. patent on alendronate expired in 2008 and Merck lost a series of appeals to block a generic version of the drug from being certified by the FDA. On February 6, 2008, the US FDA approved the first generic versions of alendronate, which were marketed by Barr Pharmaceuticals and Teva Pharmaceuticals USA. Teva Pharmaceuticals manufactures generic alendronate in 5-milligram, 10-milligram, and 40-milligram daily doses, and in 35-milligram and 70-milligram weekly doses, while Barr made generic alendronate in 70-milligram tablets, which were taken once weekly. Barr pharmaceuticals were subsequently acquired by Teva in July 2008...

Ref : http://www.effrx.com/firsteffrxnda.htm

Osteoporosis drug may be cardioprotective in hip fracture patients

In continuation of my update on alendronate

The osteoporosis drug alendronate was linked with a reduced risk of cardiovascular death, heart attack, and stroke in a Journal of Bone and Mineral Research study of patients with hip fractures. The association was seen for up to 10 years after fracture.

In the study, patients newly diagnosed with hip fracture from 2005 through 2013 were followed until late 2016. Among 34,991 patients, 4602 (13%) received osteoporosis treatment during follow-up.

Alendronate was associated with 67% and 45% lower risks of one-year cardiovascular death and heart attack, respectively. It was associated with an 18% reduced risk of stroke within five years and a 17% reduced risk of stroke within 10 years. Protective effects were not evident for other classes of osteoporosis treatments.

"It is well established that there is a world-wide crisis in the treatment of osteoporosis, due to patients' awareness of the extremely rare side effects," said senior author Dr. Ching-Lung Cheung, of the University of Hong Kong. "Our findings show that alendronate is potentially cardioprotective in hip fracture patients.

Therefore, physicians should consider prescribing alendronate or other nitrogen-containing bisphosphonates to hip fracture patients soon after their fracture, and patients should also have good compliance with alendronate treatment, as this is not only good for your bones, but also your heart."

In addition to clinical management, the study also has important implications in clinical trial design of anti-osteoporosis medications. The US Food and Drug Administration recently requested more data before reaching a decision on whether to approve the osteoporosis drug romosozumab, due to excess cardiovascular adverse events in the romosozumab arm compared with the alendronate arm. "In light of these important deliberations, our results suggest that such differences in cardiovascular adverse events could be potentially related to a protective association of alendronate, rather than an increase in cardiovascular adverse events related to romosozumab use, said Dr. Cheung."

 Ref : http://newsroom.wiley.com/press-release/osteoporosis-drug-may-benefit-heart-health

Osteoporosis drug may be cardioprotective in hip fracture patients