Showing posts with label Approved. Show all posts
Showing posts with label Approved. Show all posts

Sunday, 9 October 2016

Capsaicin Patches At 8 Approved For Nerve Pain Problems


Today's short post from painweek.org (see link below) reports that a new study (supported by the makers of the patch) has shown that another group of neuropathy patients (in this case, diabetes patients) will benefit from 8% capsaicin patches (for instance Qutenza) and will suffer less pain and better sleep patterns. These patches are nothing new of course but previously, certain neuropathy groups have been excluded from official recommendations. Capsaicin has certainly been proved to be one of the few effective treatments against nerve pain but it's not easy to administer and patients need to watch out for burn and other skin reaction problems. Many people currently use capsaicin creams, or other strength capsaicin patches but the evidence seems to suggest that the strong ones (8%) are the most effective. Worth talking to your doctor about if you haven't tried them before but you will need careful control! More articles concerning capsaicin to be found by using the search button to the right of this blog.
 
Study Supports EU Action to Extend Approval of Capsaicin Patch to Include DPN
October 2015

Results of a phase 3 study presented last month at the European Association for the Study of Diabetes (EASD) 2015 Meeting in Stockholm found that patients with diabetic peripheral neuropathy who received a capsaicin 8% patch experienced more complete pain relief and better sleep quality than those who received a placebo patch. The study was supported by Astellas Pharma Europe, which also announced at the meeting that the patch had received approval in the European Union for the additional indication of the treatment of adult diabetes patients with peripheral neuropathic pain, either alone or in combination with other pain treatments.

The capsaicin patch had previously been approved for use in the EU for neuropathic pain, and in the United States is approved for the treatment of postherpetic neuralgia, but this label doesn’t include diabetes patients. At the EASD meeting, Malcolm Stoker, PhD, global medical lead at Astellas Pharma Global Development, the Netherlands, presented the findings of the randomized, placebo-controlled, double-blind STEP trial involving 369 participants to gauge the efficacy and safety of the patch, a dermal delivery system containing 8% capsaicin, vs placebo, following patients for 12 weeks. According to Dr. Stoker, the study found that the cohort receiving the capsaicin 8% patch reported a statistically significant improvement in pain relief and sleep quality compared with the cohort receiving a placebo patch, and that the capsaicin patch “was well-tolerated, and safety was consistent with previous studies in postherpetic neuralgia and HIV-associated neuropathy.”

To read more about techniques to combat DPN, click here.

To view a slide presentation on DPN, click here.

A news story about the above study findings, with reference to additional information from the presentation, may be read here.

Can a vegan diet improve neuropathy pain? Read an article here, and a Pain Reporter interview with lead researcher of this study, here.

http://www.painweek.org/news_posts/study-supports-eu-action-to-extend-approval-of-capsaicin-patch-to-include-dpn/

Sunday, 4 September 2016

Sensus System For Nerve Pain Now FDA Approved


Today's short post from medscape.com (see link below), talks about one of the latest devices to use electrical nerve stimulation to help with neuropathy pain. The Sensus Pain Management System has now been approved by the American FDA, which is generally a sign that something has been tested for quality and effectiveness. Finding any treatment that avoids, or at least reduces the need for more pills and tablets can only be a good thing...providing it works and is financially viable for most people. That has yet to be established but if you yourself have been treated with the Sensus system, please share your experiences with other readers of the blog by using the contact button at the top of the page, or the comments button under each article.

FDA Clears Sensus for Painful Diabetic Neuropathy

Emma Hitt, PhD  Dec 07, 2012

The Sensus Pain Management System, manufactured by NeuroMetrix, has been granted 510(k) clearance by the US Food and Drug Administration (FDA), the company announced.

The device is intended to relieve and manage symptoms of chronic intractable pain in the lower leg and foot that can occur with diabetic neuropathy. The device is a transcutaneous electrical nerve stimulator and is worn on the upper calf under clothing.

"FDA clearance of the Sensus electrode represents the last step in the regulatory pathway for the Sensus Pain Management System," noted Shai N. Gozani, MD, PhD, president and chief executive officer of NeuroMetrix. "We believe that physicians treating patients with painful diabetic neuropathy, a severe and debilitating form of chronic pain, will find Sensus to be a useful therapeutic option."

The company states that they will be launching the device commercially before the end of the year.


http://www.medscape.com/viewarticle/775812