Freienbach, December 17, 2015 — EffRx Pharmaceuticals SA today announced that the MHRA (UK Medicines & Healthcare products Regulatory Agency) has adopted two positive variations for the labelling of Binosto® – buffered effervescent alendronate for oral solution. These variations will be implemented through the Decentralized Procedure (DCP) in the other European territories where Binosto® is approved.
The label now indicates that the specific Binosto® pharmaceutical formulation “minimises the possibility of exposing the oesophagus (in case of reflux) and the stomach to acidified alendronate.”
The Binosto® label also includes study data published in the International Journal of Pharmaceutics, “Modulation of gastric pH by a buffered soluble effervescent formulation: A possible means of improving gastric tolerability of alendronate.” The updated label also highlights that Binosto® is a buffered formulation for oral solution and provides the pH of this novel pharmaceutical form.
For anyone with osteoporosis, the best protection against suffering from a life-threatening fracture is taking medications as prescribed. However, studies show that many patients are not adherent to therapy or have trouble in swallowing pills, and stop taking their medication. The updated label supports the rationale that Binosto® has the potential to improve long-term patient adherence to therapy, thereby decreasing the risk of disabling fractures. The new label will also help to differentiate the hybrid approved Binosto® from generic alendronate formulation in the market.
Aileen Dowling, Head of Regulatory Affairs at EffRx, comments that “this label update reinforces the hybrid nature of the product, a different pharmaceutical form, being easier to swallow and incorporating a buffer system that can address oesophageal tolerability of alendronate tablets.“
Binosto® is currently available by prescription in Europe in the following countries: UK, Italy, Spain, and Portugal. The initial uptake in Europe with almost half a million monthly prescriptions in the first year has been very promising. Binosto® is licensed in over 50 countries and in the process of gaining regulatory clearance in several territories, hence further expanding its global footprint.
About EffRx Pharmaceuticals
EffRx Pharmaceuticals is an innovative specialty pharmaceutical company that develops and commercializes novel therapeutic entities for orphan and specialty indications by applying its proprietary technology platform. EffRx developments focus at improving the quality of life of patients with unmet medical needs.
Binosto® – the first and only buffered solution for the treatment of osteoporosis – delivers gold standard fracture-risk reduction and offers the potential to improve adherence to therapy. Buffering minimizes the possibility of exposing the oesophagus (in case of reflux) and the stomach to acidified alendronate1. Binosto® is taken once a week as an easy-to-swallow, buffered solution with no risk of a tablet getting lodged in the oesophagus. Binosto® has the potential to improve long-term patient adherence to therapy, thereby decreasing the risk of disabling fractures.
Please refer to the official Binosto® Prescribing Information and approved indications, contraindications, and warnings in your country.
1Approved SmPC in Europe: www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1447998343651.pdf
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