New non-addictive drug may be better painkiller than morphine

Nanotechnology
(c) BLB Solicitors

Feb 15th, 2019 | article by Richard Lowes

We have considered in an earlier article how nanotechnology – science and engineering on an extremely small scale – may help to revolutionise medicine, including the way that drugs act within the body.

We have considered in an earlier article how nanotechnology – science and engineering on an extremely small scale – may help to revolutionise medicine, including the way that drugs act within the body.

The increased focus in recent years on opioid dependency among people suffering chronic pain has served to intensify the race among nanotechnologists to find new types of drugs and delivery systems which are as effective as opioids but with less risk of addiction. One particular direction which has been explored is the possibility of harnessing substances that occur naturally in the human body, thereby reducing the possibility of addiction.

Enkephalin

One such substance is a peptide called enkephalin, a naturally occurring opioid-like substance which is released by neurons in the central nervous system. It has the potential to be a very potent painkiller, but on its own it has a significant limitation – it struggles to cross the crucial blood-brain barrier to bind with its corresponding opioid-receptor system. So that’s where nanotechnology is coming to the rescue.

Promising results

Researchers in France have been successful in coating enkephalin in nanoparticles, likened to a type of biological fat. This coating makes it far easier for enkephalin to cross the blood-brain barrier to locate its corresponding receptor system.

Early results seem extremely promising and an additional benefit is that the painkilling effect seems longer lasting than morphine. The researchers say:

Although further studies are needed to more precisely determine how dosage, administration frequency, and timing of treatment with [coated enkephalin] may affect the clinical outcome, this study opens a new exciting perspective for an efficient treatment of intense pain, which evades the severe side effects associated with morphine or related synthetic opioids.

In addition, the versatility of this technology means that there is huge potential to use it as a delivery system for other types of naturally occurring substances which may have a pharmaceutical value.

The increased focus in recent years on opioid dependency among people suffering chronic pain has served to intensify the race among nanotechnologists to find new types of drugs and delivery systems which are as effective as opioids but with less risk of addiction. One particular direction which has been explored is the possibility of harnessing substances that occur naturally in the human body, thereby reducing the possibility of addiction.

Enkephalin

One such substance is a peptide called enkephalin, a naturally occurring opioid-like substance which is released by neurons in the central nervous system. It has the potential to be a very potent painkiller, but on its own it has a significant limitation – it struggles to cross the crucial blood-brain barrier to bind with its corresponding opioid-receptor system. So that’s where nanotechnology is coming to the rescue.

Promising results

Researchers in France have been successful in coating enkephalin in nanoparticles, likened to a type of biological fat. This coating makes it far easier for enkephalin to cross the blood-brain barrier to locate its corresponding receptor system.

Early results seem extremely promising and an additional benefit is that the painkilling effect seems longer lasting than morphine. The researchers say:

Although further studies are needed to more precisely determine how dosage, administration frequency, and timing of treatment with [coated enkephalin] may affect the clinical outcome, this study opens a new exciting perspective for an efficient treatment of intense pain, which evades the severe side effects associated with morphine or related synthetic opioids.

In addition, the versatility of this technology means that there is huge potential to use it as a delivery system for other types of naturally occurring substances which may have a pharmaceutical value.

Source: article published with permission of BLB Solicitors

Ambroxol: a wonder drug for neuropathic pain?

Ambroxol
(c) BLB Solicitors

Feb 15th, 2019 | article by Richard Lowes

Ambroxol is a drug that breaks up phlegm. As such it is used in medicines for the treatment of conditions which result in airway congestion such as asthma, bronchitis, coughs and colds. More recently, however, studies have shown that it may also be an effective drug for the treatment of the symptoms of neuropathic pain.

Ambroxol is a drug that breaks up phlegm. As such it is used in medicines for the treatment of conditions which result in airway congestion such as asthma, bronchitis, coughs and colds. More recently, however, studies have shown that it may also be an effective drug for the treatment of the symptoms of neuropathic pain.

CRPS

In a 2018 study, eight patients who had suffered Complex Regional Pain Syndrome (CRPS) for less than 12 months were treated with ambroxol as a topical cream in a concentration of 20%. The researchers found that “Following treatment we found a reduction of spontaneous pain (6 patients), pain on movement (6 patients), edema (seven patients), allodynia (six patients), hyperalgesia (seven patients), reduction of skin reddening (four patients), improvement of motor dysfunction (six patients) and improvement of skin temperature (four patients).

Unsurprisingly, this led them to conclude that “Topical treatment with ambroxol cream may ameliorate symptoms of CRPS.

Fibromyalgia

2017 saw the publication of two studies into the effect of ambroxol on the symptoms of Fibromyalgia.

The first study involved 25 patients taking ambroxol orally, three times a day for a month. This was a very small-scale, short-term pilot study and researchers warned additionally that the open nature of the study did not allow them to rule out the possible role of the placebo effect in the results. However, the drug was said to be “well tolerated” and “side effects were minor”. The conclusion was that “the use of ambroxol was associated to decreased fibromyalgia pain and improved fibromyalgia symptoms.

In the second study, which was entitled “Ambroxol for the treatment of fibromyalgia: science or fiction?”, the authors concluded that “fibromyalgia treatment with ambroxol should be systematically investigated, since this compound is the only treatment option used thus far that has the potential to address not just individual but all of the aforementioned aspects of pain.

That’s quite a statement! However, they were swift to stress that it’s still early days and that “at this point, the evidence base for ambroxol is currently not strong enough for clinical recommendation.

Trigeminal Neuralgia

January 2019 saw the publication of another small-scale study involving the use of ambroxol as a topical cream. This time, “clinically significant pain relief” was seen within 15 to 30 minutes in patients suffering Trigeminal Neuralgia who applied the cream following a pain flare. Pain relief was said to last between 4 and 6 hours and “in one case pain was eliminated after 1 week.

In fact, so impressed were the researchers that they concluded “In view of the positive side effect profile, topical ambroxol for patients with such a highly impaired quality of life should be investigated further as a matter of urgency.

How does ambroxol work?

It is thought that ambroxol’s analgesic properties arise from its action as a potent sodium and calcium channel blocker. It is these channels within the peripheral nervous system that carry pain signals. Other studies also note its anti-inflammatory properties.

Preliminary conclusions

Clearly, researchers in all of the small-scale studies published so far believe that ambroxol shows real promise as a treatment for the symptoms of a variety of types of neuropathic pain. However, the reality is that the current absence of large-scale clinical trials means that it is years from reaching the market. This is a huge shame because, as far as can be determined currently, unlike so many other drugs used in the treatment of neuropathic pain, ambroxol seems to be both non-addictive and to have very few side-effects. An added benefit is that, in certain situations, it can be applied topically.

Fortunately, at the very least there does seem to be a desire among the research community to push forward with larger-scale studies. Unfortunately, as with so many other promising treatments and therapies for chronic pain, it is yet another example of ‘watch this space’!

CRPS

In a 2018 study, eight patients who had suffered Complex Regional Pain Syndrome (CRPS) for less than 12 months were treated with ambroxol as a topical cream in a concentration of 20%. The researchers found that “Following treatment we found a reduction of spontaneous pain (6 patients), pain on movement (6 patients), edema (seven patients), allodynia (six patients), hyperalgesia (seven patients), reduction of skin reddening (four patients), improvement of motor dysfunction (six patients) and improvement of skin temperature (four patients).

Unsurprisingly, this led them to conclude that “Topical treatment with ambroxol cream may ameliorate symptoms of CRPS.

Fibromyalgia

2017 saw the publication of two studies into the effect of ambroxol on the symptoms of Fibromyalgia.

The first study involved 25 patients taking ambroxol orally, three times a day for a month. This was a very small-scale, short-term pilot study and researchers warned additionally that the open nature of the study did not allow them to rule out the possible role of the placebo effect in the results. However, the drug was said to be “well tolerated” and “side effects were minor”. The conclusion was that “the use of ambroxol was associated to decreased fibromyalgia pain and improved fibromyalgia symptoms.

In the second study, which was entitled “Ambroxol for the treatment of fibromyalgia: science or fiction?”, the authors concluded that “fibromyalgia treatment with ambroxol should be systematically investigated, since this compound is the only treatment option used thus far that has the potential to address not just individual but all of the aforementioned aspects of pain.

That’s quite a statement! However, they were swift to stress that it’s still early days and that “at this point, the evidence base for ambroxol is currently not strong enough for clinical recommendation.

Trigeminal Neuralgia

January 2019 saw the publication of another small-scale study involving the use of ambroxol as a topical cream. This time, “clinically significant pain relief” was seen within 15 to 30 minutes in patients suffering Trigeminal Neuralgia who applied the cream following a pain flare. Pain relief was said to last between 4 and 6 hours and “in one case pain was eliminated after 1 week.

In fact, so impressed were the researchers that they concluded “In view of the positive side effect profile, topical ambroxol for patients with such a highly impaired quality of life should be investigated further as a matter of urgency.

How does ambroxol work?

It is thought that ambroxol’s analgesic properties arise from its action as a potent sodium and calcium channel blocker. It is these channels within the peripheral nervous system that carry pain signals. Other studies also note its anti-inflammatory properties.

Preliminary conclusions

Clearly, researchers in all of the small-scale studies published so far believe that ambroxol shows real promise as a treatment for the symptoms of a variety of types of neuropathic pain. However, the reality is that the current absence of large-scale clinical trials means that it is years from reaching the market. This is a huge shame because, as far as can be determined currently, unlike so many other drugs used in the treatment of neuropathic pain, ambroxol seems to be both non-addictive and to have very few side-effects. An added benefit is that, in certain situations, it can be applied topically.

Fortunately, at the very least there does seem to be a desire among the research community to push forward with larger-scale studies. Unfortunately, as with so many other promising treatments and therapies for chronic pain, it is yet another example of ‘watch this space’!

Source: article published with permission of BLB Solicitors

UK war on opioids: new prescribing guidelines to be developed

pills
(c) BLB Solicitors

Feb 28th 2019 | article by Libby Parfitt

As chronic pain patients have feared, it looks like the war on opioid painkillers has reached the UK.

There’s been a spate of reports in newspapers recently, highlighting the extent of opioid prescribing in the UK and the dangers associated with it. The Times published a lengthy report showing that there’s been a sharp rise in the number of painkiller prescriptions issued, especially in the North, where they’re prescribed four times more than in London. The Daily Mail covered the sad tale of a woman who accidentally overdosed after initially being prescribed opioids to cope with back pain. The BBC has found that Swansea has the highest rate of opioid deaths in the country where 16 people per 100,000 died from the painkillers in 2017. And who could forget the Ant McPartlin addiction feeding frenzy? I could go on and on. The reality is that the statistics are scary. There’s no doubt that these medicines are potentially addictive and potentially lethal.

What’s going to happen?

Off the back of these reports, the National Institute for Health and Care Excellence, known as NICE, which functions as the health watchdog, has decided to create new guidelines for GPs on prescribing opioid painkillers. The guidelines will cover safe prescribing of these drugs and how to manage patients withdrawing from painkillers. They’re expected to be completed and issued to GPs in 2021.

Are opioids simply bad?

If you read the newspapers, you’d probably come away with the impression that opioid medicines are killers that should probably be banned altogether. They’re presented as horror drugs that will turn you into a junkie and destroy your life. Much is said about the fact that most heroin addicts started off taking opioids. Whilst no medical bodies are advocating for the outright prohibition of these painkillers, there’s certainly noises being made about restricting them to patients in short-term pain or suffering with late-stage cancer.

But like we’ve seen in the USA, this simplistic narrative just doesn’t tell the whole story.

The sad tale of Bryan Spece and the patients being abandoned

Back in 2017, I wrote about the tragic death of Bryan Spece. Bryan was a US chronic pain patient who was prescribed oxycodone for back pain and carpal tunnel syndrome and according to his doctor and his family, he was doing really well on that prescription.

However, in early 2017 the prescribing environment in the USA changed. Opioids became public enemy number one after much the same sort of pearl-clutching, breathless reporting we’re now seeing in the UK press. Politicians saw a chance to score easy popularity points by competing to become “the toughest on drugs”; the reality of that, for Bryan, meant that his medication was taken away. No tapering, no support, no alternatives; nothing. For Bryan this was nothing short of a death sentence: he was found dead at his home on May 3rd 2017 from a self-inflicted gunshot wound.

And he’s not alone. Horrifically, there are now hundreds of cases like this in America, where legitimate patients have had the prescriptions that work for them taken away without any discussion. Where patients have been treated as addicts, as drug seekers, without any compassion or humanity. The problem is so common that you’ll regularly see the hashtag #patientsnotaddicts on social media; it’s become a rallying cry for chronic pain sufferers who are being abandoned and the medical personnel who are sticking their livelihoods on the line to support them.

It’s inhumane. It’s terrifying. And it’s what I fear may be coming to the UK.

What does this mean for patients and what can we do?

The first thing is not to panic. These guidelines won’t hit until 2021, but I’m already hearing from readers that it’s getting harder and harder to get hold of the painkillers they rely on so it’s best to start preparing for this now.

The most important thing is to try to work with your GP. Even if your prescription was initially given by a hospital or pain clinic, if you need to get it renewed regularly it will end up being prescribed by your GP, so it’s important that they understand what you’re dealing with. I’ve changed GPs three times in the eight years I’ve had CRPS due to a series of house moves. In each case, I made it a priority to find a GP at my new practice that I liked and felt I could develop a relationship with; yes, that did mean trying appointments with a few different doctors until I found the right one! It might mean a week’s wait for an appointment or that I have to make do with a telephone consultation if it’s urgent, but the benefit of having someone who really knows and understands me and my pain hugely outweighs the negatives. Your GP can be in your corner if they really grasp what you’re dealing with.

It’s also important to remember that the aim with using any painkiller should be to take the smallest amount for the shortest time. As patients, that’s a standard we should hold ourselves to at all times. That means always asking yourself “Can I reduce my medication?” People can be very wary of this, but if you’re able to have an honest and understanding relationship with your GP then this question doesn’t have to be terrifying. If you’re asked to reduce your intake, then I would advise at the very least to give it a go. Doctors don’t ask this for no reason; the truth is that opioid painkillers do have very nasty side effects, ranging from constipation to liver problems. It really would be much better if we could all do without or at the very least, take the lowest amount we can manage. But if you can’t reduce, don’t be afraid to say so. Doctors aren’t gods and you deserve to have a voice in your own care. Although it’s always way more valid to say “I’ve tried reducing the dosage and it didn’t work for me for this list of reasons” instead of not even being willing to try.

I don’t know what the future will hold for chronic pain patients like me who are dependent on opioid painkillers to function. I hope that the UK will adopt a kinder and more humane approach than the US, but it’s just too soon to tell. I’ll be following this subject closely and keeping you informed.

There’s been a spate of reports in newspapers recently, highlighting the extent of opioid prescribing in the UK and the dangers associated with it. The Times published a lengthy report showing that there’s been a sharp rise in the number of painkiller prescriptions issued, especially in the North, where they’re prescribed four times more than in London. The Daily Mail covered the sad tale of a woman who accidentally overdosed after initially being prescribed opioids to cope with back pain. The BBC has found that Swansea has the highest rate of opioid deaths in the country where 16 people per 100,000 died from the painkillers in 2017. And who could forget the Ant McPartlin addiction feeding frenzy? I could go on and on. The reality is that the statistics are scary. There’s no doubt that these medicines are potentially addictive and potentially lethal.

What’s going to happen?

Off the back of these reports, the National Institute for Health and Care Excellence, known as NICE, which functions as the health watchdog, has decided to create new guidelines for GPs on prescribing opioid painkillers. The guidelines will cover safe prescribing of these drugs and how to manage patients withdrawing from painkillers. They’re expected to be completed and issued to GPs in 2021.

Are opioids simply bad?

If you read the newspapers, you’d probably come away with the impression that opioid medicines are killers that should probably be banned altogether. They’re presented as horror drugs that will turn you into a junkie and destroy your life. Much is said about the fact that most heroin addicts started off taking opioids. Whilst no medical bodies are advocating for the outright prohibition of these painkillers, there’s certainly noises being made about restricting them to patients in short-term pain or suffering with late-stage cancer.

But like we’ve seen in the USA, this simplistic narrative just doesn’t tell the whole story.

The sad tale of Bryan Spece and the patients being abandoned

Back in 2017, I wrote about the tragic death of Bryan Spece. Bryan was a US chronic pain patient who was prescribed oxycodone for back pain and carpal tunnel syndrome and according to his doctor and his family, he was doing really well on that prescription.

However, in early 2017 the prescribing environment in the USA changed. Opioids became public enemy number one after much the same sort of pearl-clutching, breathless reporting we’re now seeing in the UK press. Politicians saw a chance to score easy popularity points by competing to become “the toughest on drugs”; the reality of that, for Bryan, meant that his medication was taken away. No tapering, no support, no alternatives; nothing. For Bryan this was nothing short of a death sentence: he was found dead at his home on May 3rd 2017 from a self-inflicted gunshot wound.

And he’s not alone. Horrifically, there are now hundreds of cases like this in America, where legitimate patients have had the prescriptions that work for them taken away without any discussion. Where patients have been treated as addicts, as drug seekers, without any compassion or humanity. The problem is so common that you’ll regularly see the hashtag #patientsnotaddicts on social media; it’s become a rallying cry for chronic pain sufferers who are being abandoned and the medical personnel who are sticking their livelihoods on the line to support them.

It’s inhumane. It’s terrifying. And it’s what I fear may be coming to the UK.

What does this mean for patients and what can we do?

The first thing is not to panic. These guidelines won’t hit until 2021, but I’m already hearing from readers that it’s getting harder and harder to get hold of the painkillers they rely on so it’s best to start preparing for this now.

The most important thing is to try to work with your GP. Even if your prescription was initially given by a hospital or pain clinic, if you need to get it renewed regularly it will end up being prescribed by your GP, so it’s important that they understand what you’re dealing with. I’ve changed GPs three times in the eight years I’ve had CRPS due to a series of house moves. In each case, I made it a priority to find a GP at my new practice that I liked and felt I could develop a relationship with; yes, that did mean trying appointments with a few different doctors until I found the right one! It might mean a week’s wait for an appointment or that I have to make do with a telephone consultation if it’s urgent, but the benefit of having someone who really knows and understands me and my pain hugely outweighs the negatives. Your GP can be in your corner if they really grasp what you’re dealing with.

It’s also important to remember that the aim with using any painkiller should be to take the smallest amount for the shortest time. As patients, that’s a standard we should hold ourselves to at all times. That means always asking yourself “Can I reduce my medication?” People can be very wary of this, but if you’re able to have an honest and understanding relationship with your GP then this question doesn’t have to be terrifying. If you’re asked to reduce your intake, then I would advise at the very least to give it a go. Doctors don’t ask this for no reason; the truth is that opioid painkillers do have very nasty side effects, ranging from constipation to liver problems. It really would be much better if we could all do without or at the very least, take the lowest amount we can manage. But if you can’t reduce, don’t be afraid to say so. Doctors aren’t gods and you deserve to have a voice in your own care. Although it’s always way more valid to say “I’ve tried reducing the dosage and it didn’t work for me for this list of reasons” instead of not even being willing to try.

I don’t know what the future will hold for chronic pain patients like me who are dependent on opioid painkillers to function. I hope that the UK will adopt a kinder and more humane approach than the US, but it’s just too soon to tell. I’ll be following this subject closely and keeping you informed.

Source: article published with permission of BLB Solicitors

Clinical trial on neridronate in Germany

Aachen. CRPS/Sudeck's disease was conducted by the pharmaceutical manufacturer Grünenthal, Aachen, to conduct a clinical study on the active ingredient neridronate. Neridronic acid) launched an aminobisphosphate. In various clinics in Germany, sufferers can take part in this clinical trial.

The studies will be conducted at sites in the US, Canada, Germany, France, the UK, Spain, Ukraine, the Czech Republic, Slovakia, Poland, Serbia, Australia, New Zealand and South Korea.

There are two placebo-controlled clinical trials that currently conduct and recruit patients. One also has clinical study centers in Germany where patients can be included in the study if they are eligible according to all inclusion/exclusion criteria.

Here's the link clinical trials.gov for this study: https://clinicaltrials.gov/ct2/show/NCT03530345?term=neridronic+acid&cond=CRPS&rank=1

The clinical study centers in Germany are:

  • Center for Clinical Research Dr. med. Medical. I. Schoel, Bad Homburg, tel: 06172/1710784
  • Clinical Research Berlin Mitte GmbH, Berlin, Tel: 030/206580-800
  • BAG anesthesia, pain therapy, palliative care, cottbus, tel: 03552/890785
  • Clinical Research Hamburg GmbH, Hamburg; Phone: 040/460763030
  • Clinical Research Hannover Mitte, Hanover, Tel: 0511/169765-0
  • Department and Department of Neurology University Medicine Mainz, Mainz, Tel: 0613iconfin0-2222
  • Clinical Research Schwerin GmbH, Schwerin, Tel: 0385/557740

Patients will need to contact the sites and potentially make an appointment to check suitability. Please note that an important criterion is that the CRPS duration from the onset of signs and symptoms is no more than 2 years. People with a longer CRPS duration cannot be considered.

Recruitment should continue until early 2020.

For inclusion in the clinical trial, there are various admission requirements named in the following document. There is also more information on the study. Contact can be made about this.

Position paper on the treatment of CRPS in Europe/Standards

A position paper on the treatment of CRPS in Europe was published in the European Journal of Pain in January. Well-known medical practitioners from Great Britain, Germany, Switzerland, Belgium, the Netherlands, France, Denmark and Poland as well as from Irsael and Australia have together put together the current methods and best practices to raise standards for treatment Set. So far, there are different good and bad treatment routes in each country and the secured diagnosis "CRPS" is either not made or not made in time.

So far, we have only been present in English for the position paper, but we are working on a translation that we will publish here.

The CRPS network has translated the position paper into German for a better understanding. The translation can be downloaded here.

CRPS Diagnostic Times survey by CRPS Network Australia

Dear people, Dear relatives, Dear friends, We just received a call from our friendly CRPS Association from Australia "CRPS Network australia" for their own worldwide study on "time to Diagnosis/treatment at CRPS". Since this survey is completely in english, we have translated it into German and also make it available. The collected data is then Merged. Excerpt from the accompanying text of the Survey:

This survey is aimed at people all over the world who have been diagnosed with the complex regional pain syndrome.  To be able to participate, you must be 16 years or older (parents/guardians are encouraged to complete this survey on behalf of children under the age of 16 with CRPS diagnosis).

» Link to the network Australia survey» link to survey in German

CRPS Patient Meeting Aachen

At the 18.05.2018, the Allianz CRPS global groups from Germany, the Netherlands, Spain and Australia met in Aachen to collaborate on drug research for CRPS, patient studies on disease and on the global cooperation of CRPS Patients ' organisations.
The groups from the United Kingdom and the United States unfortunately could not be present at this meeting. The results are, of course, shared among themselves. The aim of the meeting was mainly to find out how studies on CRPS could be raised and how to gain people affected for these studies. DANEBN was concerned with the further evaluation of own patient studies of patient organisations.