Osteoarthritis (‘OA’) is the most common form of joint disease, and is estimated to affect up to 20% of the adult population. Prevalence increases with age and comorbidities such as obesity and cardio-vascular disease are common. It has a huge economic cost on society made up from treatment costs, surgery and a host of indirect costs such as reduced productivity/loss of work, decreased independence and need for care.
Despite the costs and prevalence of OA, its aetiology and progression remain poorly understood. Its origin and advance are believed to be caused by a mix of mechanical, structural, genetic and environmental factors. There is no cure for the disease and for many the end result is total joint replacement with all its costs and limitations. The standard treatment protocol for the symptoms starts with non-pharmacological interventions beginning with patient education, exercise and weight loss; pain and inflammation are treated with common painkillers (aspirin, paracetamol (acetaminophen) and Non-Steroidal Anti-Inflammatory Drugs (NSAIDS, such as diclofenac, ibuprofen and naproxen). A 2016 study published in the Lancet (da Costa et al.) has just concluded that paracetamol is ineffective. Those receiving poor relief or who cannot tolerate NSAIDs may be given opioids (codeine, etc.).
Whilst these products provide some temporary symptomatic relief, they do so with serious safety issues that are increasingly well recognised. NSAIDs have been associated for gastro-intestinal and cardio vascular problems, in particular. The use of NSAIDs even in low doses for short periods has been linked to serious cardio-vascular adverse events, and therefore their use is cautioned against in patients with histories of heart disease. In the United States alone, it has been estimated that 8% of the adult population has coronary heart disease. NSAIDS are recognised to interact with anti-hypertension drugs such as diuretics and ACE inhibitors, negating their effect. Since many of these painkillers are available over the counter, their use is poorly controlled; a recent survey by the American Gastroenterological Association reported that 38% of respondents did not understand the risks of combining two or more NSAIDs or two or more paracetamol products.
In reality, there has been almost no significant advance since the development of ibuprofen and diclfenac in the 1970s, although the value of products with improved safety profiles was briefly shown by the growth of COX2 market to over £6bn between 1999 and 2004, which were marketed as a safer alternative to NSAIDS with their gastro-intestinal side effects before the serious cardio-vascular side effects became known.
These CV side effects have now been recognised as a class problem not limited to COX2s further reducing the options for large numbers of OA sufferers also suffering from CV problems. Another 2016 study by the working group for Cardiovascular Pharmacotherapy of the European Society of Cardiology (Schmidt et al.) concluded that non-aspirin NSAIDS should in general not be used in patients with established or high risk of cardiovascular disease.
As a result, there is a large population of patients for whom current treatments are ineffective or unsuitable. These are the patients now being helped by FLEXISEQ which offers a number of unique benefits to fill the unmet need for effective and safe treatment. FLEXISEQ is:
- Clinically proven to be as effective as a prescription pain killer (celecoxib) at relieving joint pain and stiffness associated with osteoarthritis
- Safe; no systemic exposure, no contraindications, no known interactions with medicines
- Revolutionary approach using bio lubrication to target osteoarthritis directly rather than mask pain
- Drug-free, so can be used in conjunction with medication and can be used for long-term treatment
- Wider choice of marketing opportunities than its competitors as it is classed as a medical device
- Able to lower the cost for payors as its use will not detract from other treatments’ outcomes
Current prescription products (including topical NSAIDs) in the United States carry black box warnings highlighting the class risks associated with their use. Medical advice is typically to use the lowest dose for the shortest possible time. FLEXISEQ does not have these limitations, so may be a more attractive option for long-term pain relief.
Muscle pain & other joint pain
Muscle pain, especially after exercise, is common. Oral painkillers are taken after strenuous exercise to ease pain, but also during and before exercise, creating concerns about misuse. Further there is evidence that whilst there may be pain relief, recovery may be delayed. These issues have been highlighted in professional sport where the pressure to perform is extreme.
We have tested FLEXISEQ Sport in healthy volunteers with induced Delayed Onset Muscle Soreness (‘DOMS’) and found that participants using an oral NSAID experienced 20% more pain and took on average 12 hours longer to be free of pain.
The investigators concluded that drug-free Sequessomes may have a role to play in treating pain in non-osteoarthritic settings. These findings are consistent with the experiences reported by professional athletes and their medical teams that use of FLEXISEQ assists recovery.
Further details of this trial can be found in the Journal of Sports Science.
Pro Bono Bio has started additional work with a number of medical teams to explore the impact of FLEXISEQ in other conditions including recovery from joint injury. We are working with British Athletics to investigate the impact of FLEXISEQ on elite athletes in high performance settings. We expect to report on findings during the first half of this year.