Millions of people worldwide with severe back pain may be able to get relief from a new drug that uses antibiotics rather than painkillers to tackle the condition.
Doctors who have tested the drug said it could be “a gamechanger” for the one in four people whose lower back pain is caused by an infection rather than a muscular or spinal problem.
An early stage trial of the drug found that six in 10 of those who took it experienced major benefits, including a significant decline in the pain and disability they had previously suffered.
The drug, called PP353, is in development by Persica Pharmaceuticals, a Kent-based biotech firm. It staged the trial in conjunction with six NHS hospitals in England and Wales.
Dr Shiva Tripathi, an NHS pain consultant and the chief investigator of the trial, said if the drug is approved by regulators and becomes available it would be “a gamechanger for chronic lower back pain on the similar levels as [how] antibiotics made a difference to infection. Because if we can get these 25% of the patients with chronic low back pain back to work, back to no medications, back to no more disability, then I think [that] will be the massive gamechanger for the future.”
However, the randomised controlled trial involved only 44 patients – 22 in Britain and 22 in Spain, Denmark and New Zealand – so PP353 will have to undergo further trials, and be endorsed by the medicines watchdogs, before doctors can offer it to patients to relieve their symptoms.
The patients had all had severe back pain for at least six months, and in some cases more than five years, that had not responded to conventional treatment, such as painkilling medication.
Persica said that a big advantage of their treatment is that the patient has two injections four days apart rather than undergoing surgery or taking tablets for a long time. Recent research found that most of the 56 ways of trying to alleviate back pain which researchers studied – ranging from massage and acupuncture to painkillers and physiotherapy – brought little or no real relief.
PP353 is a combination of three substances that are already widely used in medicine: linezolid, an antibiotic; iohexol, a contrast agent or dye; and a thermosensitive gel. It is injected into the lower back in order to banish an infection that has developed around the discs.
Steve Ruston, the firm’s chief executive, said: “Our first patient trial produced really positive results. [It produced] significant reductions in pain and disability and [patients also got] clinically meaningful benefit and statistically significant benefit. The patient benefit potential is enormous.
“If you can reduce the pain and disability that people are living with in the way that some of our [trial] patients have responded, it will transform their lives.”
Market research shows that 2 million people in the US and 250,000-300,000 in the UK could benefit, he added. “Millions of people around the world can benefit from this. But low back pain is not just a first-world problem; everybody gets low back pain.”
The drug is different from other back pain treatments, Ruston added, because it targets the underlying cause of the problem rather than just its main symptom – pain.
Low back pain is one of the world’s commonest health problems. Six in 10 people in the UK develop it at some point. It is expected to grow as a problem worldwide because of the ageing and growing population. It is often hard to diagnose the cause and even harder to treat successfully.
Many patients in the trial experienced a drop in the amount of pain they were suffering within a month of the injections and were still feeling a lot better after a year, Persica said. However, it reduced, but did not remove, the need to keep taking painkillers, Ruston added.
But Dr Benjamin Ellis, a consultant rheumatologist at Imperial Healthcare NHS trust in London, who specialises in chronic pain, voiced scepticism about PP353’s potential.
“Modern medicine has largely failed people with chronic – in other words, long-term – back pain. But there is little evidence that interventions using surgery or injections, or even taking medicines, makes much difference for the vast majority of people with chronic low back pain.
“People with chronic low back pain are understandably desperate for anything that can help. There’s also a huge industry in supplying technologies and medicines that claim to help, but little evidence that these do.
“Promising holistic approaches, such as cognitive functional therapy, often don’t get a look in, particularly when services are overstretched.
“That being said, if there is a subgroup of people with chronic low back pain that can reliably and safely benefit from a simple pair of injections, then that would be fantastic news – but it seems unlikely.”