Pro Bono Bio®, the global leader in nano-physical healthcare products, announces that a review of the published clinical trial data supporting its drug-free osteoarthritis treatment FLEXISEQ™, has been published in Current Medical Research Opinion (CMRO)1. FLEXISEQ’s proven efficacy comes with significant advantages as the product has no contra-indications, contains no drugs so cannot cause drug-to-drug interactions, and with over 6 million doses administered since launch there have been no reported systemic side effects.
The article is the latest high profile publication in 2013 for the product after winning a German pharmacy award for innovation in January. FLEXISEQ™ is now available from all LloydsPharmacy stores and online at arthritisresearchuk.org in the UK, and all pharmacies in Austria, Germany, Ireland, as well as in Malaysia and Singapore.
Prof Philip G Conaghan of the University of Leeds, lead author of the CMRO international paper, said: “Osteoarthritis is a common condition, especially in the growing number of elderly people. It causes chronic pain and stiffness which adversely affects patients’ lives. The need for new treatment options is well recognised as existing treatments don’t always work and many can cause serious side effects. Many OA patients are elderly and have additional health conditions that mean they are especially at risk of these side effects. Safety is therefore a key concern for new therapies and patients and healthcare professionals would welcome new treatment options which are effective and without such safety concerns.
A spokesperson for Arthritis Research UK, a leading medical research charity focused on Arthritis in the UK, said: “Flexiseq has driven a significant increase in visitor numbers to our website arthritisresearchuk.org as patients can buy the product there. It has quickly become a best seller.”
Commenting on FLEXISEQ, Nitin Makadia, LloydsPharmacy pain expert and pharmacist, said: “Since FLEXISEQ launched in the UK earlier this month we have seen an overwhelming response from our customers. Pain caused by osteoarthritis affects a significant number of people in the UK and we are pleased that this product is having a positive impact on people’s lives. Due to the popular demand we have decided to extend the product‘s availability to all our pharmacies across the UK, meaning patients can exclusively buy FLEXISEQ at their nearest LloydsPharmacy.”
Dr Werner Kneer, an Orthopaedic Specialist from Stockach, Germany, an investigator in some of the FLEXISEQ studies and a co-author of the CMRO publication said; “The proven physical mode of action and the lack of an active pharmaceutical ingredient gives FLEXISEQ the best of both worlds: it works and it’s safe. The lack of the systemic side effects reported when pain-relieving drugs are used chronically, such as gastrointestinal bleeding, kidney failure, heart attack and stroke, together with a lack of drug interactions makes FLEXISEQ a particularly suitable option for many OA patients. These patients are usually elderly and often suffering from other conditions and taking other medications; both factors complicate the choice of therapy for their painful joints. The problems with using medications such as the non-steroidal anti-inflammatory drugs, particularly in these at-risk patients are becoming increasingly well recognised, as demonstrated, for example, by the paper published in the Lancet2 earlier this year, and so we believe that FLEXISEQ is a very valuable addition to the treatment options available.”
The publication reports that FLEXISEQ (TDT 064), was equivalent to the oral NSAID celecoxib (the active comparator arm in a key trial) and was much better tolerated by patients.
Dr Matthias Rother, a co-author of the CMRO article, from Gräfelfing emphasised; “NSAIDs should be taken only in the lowest possible dose and for the shortest possible period however the reality is very different. Since NSAIDs are largely acquired and used without a prescription, patients with well-known risk factors like cardiovascular, gastrointestinal or nephrological diseases take these potentially dangerous drugs unmonitored, unfortunately frequently also in excessive doses. Only in June 20133 urgent safety information was issued based on corresponding study results regarding a new recommendation in dealing with diclofenac. Therefore, the drug is now contraindicated in patients with existing cardiac insufficiency, ischemic heart disease, peripheral arterial disease or cerebrovascular disease. Especially for elderly patients, who also suffer particularly frequently from osteoarthritis, several of these restrictions often apply. The fact that their complaints are not temporary but permanently present makes it more difficult.”
Michael Earl, a director of Pro Bono Bio said: “Sufferers of osteoarthritis are not presented with a lot of different options when it comes to treatments and it is, sadly, inevitable that a subset of these patients will develop unpleasant and potentially hazardous side effects due to their treatment. FLEXISEQ offers some hope to this “at risk” population as a topical, drug-free intervention with clinically meaningful efficacy”.
1 Conaghan P, et al Curr Med Res Opin 2013;1-13 November 2013
2 Coxib and Traditional NSAID Trialists’ (CNT) Collaboration. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet 2013; pii: Q5 S0140-6736(13)60900-9
3EMA/592685/2013
Ascension Healthcare plc is a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapies for the treatment of haemophilia and osteoarthritis. The Company has three products in clinical development for the treatment of haemophilia A and also a range of internationally marketed products for osteoarthritis sufferers. For more information please visit: www.ascension.co.uk/
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