The days of joint pain and limited mobility may be numbered for osteoarthritis (OA) patients who go through the daily stress of coping with their condition. The UK’s Charity launch of a drug-free water-based gel, Flexiseq, aims to provide OA relief without the side effects associated with painkillers.
The product’s launch is in conjunction with Arthritis Research UK and 500 branches of LloydsPharmacy in the U.K. who have decided to have a limited release. Flexiseq’s selective launch serves as a unique way to provide contribution to medical research by supplying Arthritis Research UK to sell the gel at a reduced price equivalent to $23 or per pack and to produce funds for the charity. The equivalent of $1.36 will be donated to Arthritis Research UK for every tube LloydsPharmacy sells during the UK Charity launch period.
"Current approaches to treating this chronic pain are inadequate, and we are interested in the potential of this new drug-free approach," said Dr. Liam O’Toole, chief executive, Arthritis Research UK, about Flexiseq in the press release.
Unlike several OA treatments like acetaminophen, nonsteroidal anti-inflammatory drugs (NSAID) and narcotics, Flexiseq does not contain an active pharmaceutical ingredient. “The real difference that is provided by the absence of drug, substituted with a physical mode of action, is the safety profile,” said Michael Earl, chief operating officer of Pro Bono Bio, maker of the product. The gel does not cause any systemic side-effects such as gastrointestinal bleeding, kidney failure, heart attack, or stroke, unlike other drugs used chronically. The absence of the drug in Flexiseq means the absence of drug-to-drug interactions.
The topical treatment consists of millions of droplets of fat, also known as phospholipids, which travel through the skin and tissue as it penetrates the joint. Flexiseq appears to be effective for OA patients because the condition typically depletes the level of phospholipids in the joint, which is normally found in the liquid around the cartilage. Phospholipids play an essential role in lubricating the joint — a benefit for OA patients whose deficiency can lead to pain, stiffness and loss of function. Flexiseq aims to reduce the friction between the attached bones, resulting in less pain and improved mobility.
The effectiveness of the gel may be seen as early as two days after the start of treatment. “Anecdotally, some patients report effects much quicker than this, but we don’t have formal data to support it," Earl said.
Prior to its UK Charity launch, the effects of Flexiseq were measured in six clinical trials involving 4,000 patients. These OA sufferers experienced reduced pain and better mobility with the administration of the drug.
In a study, published in the journal Rheumatology, researchers sought to assess the efficacy and safety of a 12-week treatment with ketoprofen, a NSAID, in ultradeformable phospholipid vesicles in over 1,300 patients with OA knee pain and compare it to the efficacy of ketoprofen-free vehicles Flexiseq and celecoxib. OA treatment with either Flexiseq or celecoxib was found to be more effective in comparison to ketoprofen in ultradeformable phospholipid vesicles and the placebo. However, Flexiseq had the advantage of a safety profile because it did not have any side-effects.
The use of the gel may not be advised for all patients. Earl said pregnant women and those with a known allergy to any of the components in the product should proceed with caution. The researchers simply do not have data on the use of the product among pregnant women through their clinical trials, but he affirmed they have no reasons to suspect it will cause any complications.
Allergy patients may still use the product but should take precautionary steps. "In patients with known allergies our advice is to use the product in a small area first to trial it. It is worth saying that all the components in the vesicles in the product are regarded by the FDA as 'GRAS,'" generally regarded as safe, he added.
The distinguishing characteristic of the product does not remain in what the product contains but how those components are engineered into the Sequessome vesicles.
Flexiseq has been successfully sold in Austria, Germany, Ireland, Malaysia, and Singapore. The press release says the drug-free gel launched in Ireland in June and has become one of the fastest growing over-the-counter products in nation-wide pharmacies.
The gel is expected to come out in stores at the end of January 2014 in the UK. It is expected the Arthritis Research UK will continue to sell FLEXISEQ from their website to raise funds for important medical research.
It has yet to be known whether a similar product will become available in the U.S. in the immediate future.
The Centers for Disease Control and Prevention says 27 million American adults are affected by OA, the most common form of arthritis. OA typically causes weakness and disability and interferes with a person’s ability to work, resulting in joint replacements. The prevalence of OA begins to steadily increase beginning at the age of 45 with one in two Americans susceptible to developing symptomatic knee OA in their lifetime.
To learn more about Flexiseq, click here.
Bolten W, Conaghan PG, Dickson J et al. A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology. 2013.