Pain Drug Reaches Phase 3 Clinical Trials | Dallas Legal Examiner | Dallas Texas Personal Injury Lawyer

Posted by Bryan Pope
June 7, 2016 8:55 AM

A Pittsburg-based drug development company has received U.S. Food and Drug Administration (FDA) approval for phase 3 clinical trials of a product to treat severe, persistent pain. The medication, T-121, is being developed by Thar Pharmaceuticals and is expected to enter the market by 2019. T-121 is an oral version of Novartis’ intravenous-only zoledronic acid, which is sold under the brand name Zometra. T-121 will be intended for patients suffering from complex regional pain syndrome/reflex sympathetic dystrophy (CRPS/RSD), a chronic pain condition often brought on by some sort of trauma. About 70,000 people across the U.S. experience pain from CRPS/RSD, which can become chronic over time and become a disabling condition.

Treatments for CRPS/RSD.

There are many different types of treatments for CRPS and new ones come about relatively frequently, although what works for one does not usually work for another, making treating the condition all the more difficult. Generally, the earlier CRPS is caught and treated correctly, the greater the chance that the condition will respond to medical treatment. Although most doctors agree that a combination of diet, exercise, physical therapy, and medication is the best treatment of CRPS for most patients, exactly what that combination may be and which medications work best is a highly debated issue among pain management doctors. There are no FDA-approved treatments for the pain of CRPS/RSD. Thar Pharmaceuticals developed the drug through the FDA’s orphan disease program, which allows for expedited review, tax credits and other competitive advantages for medications that help fewer than 200,000 people.

CRPS/RSD affects fewer than 200,000 patients in the U.S. each year, according to the National Organization for Rare Disorders.

Source: Pain Drug Reaches Phase 3 Clinical Trials | Dallas Legal Examiner | Dallas Texas Personal Injury Lawyer

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National Pain Strategy PAINS Collaborators Meeting Recap – COMMUNITY PAIN CENTER

National Pain Strategy PAINS Collaborators Meeting Recap

By Barby Ingle, Power of Pain Foundation President

On June 29 and 30, 2015, the Pain Action Alliance to Implement a National Strategy (PAINS), a group of over 100 pain collaborators and stakeholders, came together in Washington DC to discuss the National Pain Strategy (NPS). The purpose was to provide attendees an opportunity to discuss the NPS and find areas of agreement on next steps, collaborations, priorities, and to hold accountable those responsible for implementation.As the president of the Power of Pain Foundation, I was invited to participate. I went into the meeting with some preconceived notions based on little happening since the Institute of Medicine’s report in 2011 and didn’t expect much to be accomplished. To my great surprise, the meeting exceeded my expectations. I left the meeting feeling that a path toward implementation of stronger access to care issues was clarified as a result of the meeting. I am excited to be one of the attendees present that will be helping move a chronic pain agenda forward, making a difference in the lives of those living with pain.The goals of the meeting were to encourage collaboration among key pain community leaders, to promote the NPS report and build enthusiasm for it, and to facilitate conversations about how to move forward to implementation of the strategy outlined in the report.For me, the meeting clarified the path ahead for the NPS in terms of priorities,implementation, next steps, funding,leadership and accountability. One of the unintended outcomes from the meeting was the consensus to support the messaging of the Chronic Pain Advocacy Task Force (CPATF). The CPATF is a group of 17 consumer advocacy groups convened by the State Pain Policy Action Network (SPPAN), which is a program of the American Academy of Pain Management (AAPM). As a founding member of the CPATF and the representative of one of the 17 groups involved, I was very proud to see that our work was recognized by this larger group of collaborators and stakeholders. As agreed upon, the core messages are: Chronic pain is a real and complex disease that may exist by itself or be linked with other medical conditions.Chronic pain is both an under-recognized and under-resourced public health crisis with devastating personal and economic impact. Effective chronic pain care requires access to a wide range of treatment options, including biomedical, behavioral health and complementary treatment. Denying appropriate care to people with chronic pain is unethical and can lead to unnecessary suffering, depression, disability, and even suicide.

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Source: National Pain Strategy PAINS Collaborators Meeting Recap – COMMUNITY PAIN CENTER

Complex Regional Pain Syndrome: CPRS researchers study auditory connection

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Kerry Whyman suffers from complex regional pain syndrome, which makes her highly sensitive to noise. Photo: Paul Jeffers

December 6, 2015 – 12:15 AM

For 16 years, Kerry Whyman secretly thought she had bone cancer and was dying – “secretly” because she’d stopped telling doctors how much pain she was in.”I’d wake up and my ankles were swollen and bruised, like they were sprained,” says Ms Whyman, 55. “The doctor would ask ‘what have you done?’ I’d say ‘nothing.’ He’d send me for ultrasounds and they’d come back normal … I decided to shut up because I felt I looked stupid.”If the pain wasn’t in her ankles, it was somewhere else, sometimes in her organs. It seemed to move around Whyman’s body at will. And it became more intense when she was exposed to noise. “My television is turned down to the lowest volume possible, and it’s still too loud.”She got by all those years on paracetamol, anti-inflammatories and lot of drinking. Advertisement. One day in 2008 Whyman met a woman with the same symptoms. The woman told Whyman that she was suffering Complex Regional Pain Syndrome, a rare and baffling condition that was first described during the American Civil War – and until 10 years ago was routinely dismissed as a psychiatric disorder.”When I asked my GP if I had CRPS, he said he’d never heard of it. He thought I had carpal tunnel syndrome. But tests showed I didn’t.”A neurologist finally confirmed CRPS. It most likely began when Whyman fell and fractured her right wrist 23 years ago. In most cases, Complex Regional Pain Syndrome is an ongoing consequence of a fractured limb – the broken bones heal, but the pain lingers, wanders randomly, and is aggravated by changes in weather, stress and noise. Since the diagnosis, Whyman has been on “a merry-go-round” of treatments, most of them not working. The only thing that has given Whyman relief has been intravenous injections of ketamine, the hallucinatory anaesthetic.Three times a year she is admitted to hospital for a week, and kept on an intravenous drip. She’s knocked around but the pain goes away. Except in September, her most recent hospitalisation – it didn’t work. She’s resisting suggestions to undergo direct stimulation of the spine.”They say I’m a perfect candidate, but surgery has to be the last resort,” she says.Depending on the research, there are between five and 25 new cases of Complex Regional Pain Syndrome per 100,000 every year. The actual prevalence is much higher because people, like Whyman, suffer for years.About one in 10 people with a fracture go on to develop some form of the pain syndrome, says Professor Peter Drummond, a psychologist at Murdoch University, one of the few people doing research into the causes.The Australian & New Zealand College of Anaesthetists is funding a study by Professor Drummond and Adjunct Professor Philip Finch, a pain medicine specialist, to unravel some of the complexity. They have together been researching various aspects of CRPS for 25 years.A recent study found there is an increased number of alpha-1 adrenoceptors on skin cells and nerves in the damaged limb of Complex Regional Pain Syndrome patients. These receptors are involved in the stimulation of the sympathetic nervous system, which controls the “fight or flight” response. It may be that pain nerves are being over-stimulated. The researchers are further exploring this discovery.”We’re not sure why these receptors are over-expressed,” says Drummond. “It seems to be a product of injury to the nerve itself or the inflammatory process. We’re studying that in cell cultures, to work out what the stimulus it might be.”The new project is looking at the idea that the brain, in failing to adequately suppress pain, distorts normal sensory processing in the syndrome.In a world first, Drummond and Finch will study the interaction between the auditory and pain-processing systems in CRPS patients. They plan to measure brain stem activity as the left and right ears of patients and a healthy control group are subjected to various noises. They are guessing that noises heard on the injured side of patients – reportedly are distorted and painful – will generate wave forms in the brain different to those generated by the auditory system on the healthy side.Drummond and Finch expect they will be disentangling Complex Regional Pain Syndrome for many years to come.

Source: Complex Regional Pain Syndrome: CPRS researchers study auditory connection

Commentary- Kerry Lynn is an international chronic pain advocate and published writer with a focus on CRPS.

I’m thankful for her contributions.

Microglia Activation Causes Depression, Anxiety in Chronic Pain

June 11, 2015

Brain inflammation from chronic pain increases microglia activation, which inhibits the release of dopamine and may lead to depression and anxiety, according to a study published in The Journal of Neuroscience.

Although more than half of chronic pain patients experience depression, anxiety, or substance abuse, scientists were unable to determine what caused this association until now. In this study, the researchers sought to test if chronic pain disrupted the transmission of dopamine.

The researchers demonstrated that the activation of microglia in mice with chronic pain inhibited the release of dopamine. These results shed light on why opioids, which stimulate a dopamine response, can be ineffective for chronic pain patients.

The researchers instead tested a drug that inhibited the activation of microglia. This, they found, restored normal dopamine release and reward-motivated behavior in the mice.

“For over 20 years, scientists have been trying to unlock the mechanisms at work that connect opioid use, pain relief, depression and addiction,” said Catherine Cahill, PhD, of the University of California, Irvine. “Our findings represent a paradigm shift which has broad implications that are not restricted to the problem of pain and may translate to other disorders.”­

In future studies, the researchers hope to explore if mood disorders are caused by similar brain alterations, regardless of the presence of chronic pain.

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via Microglia Activation Causes Depression, Anxiety in Chronic Pain.

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The Journal of Neuroscience

Microglia Disrupt Mesolimbic Reward Circuitry in Chronic Pain

High-Frequency Surpasses Traditional Spinal Cord Stimulation in First Controlled Trial Comparing Technologies

Released: 24-Mar-2015 2:05 PM EDT 

Newswise — March 24, 2015, NATIONAL HARBOR, Md. –- The first-ever randomized, controlled trial to compare spinal cord stimulation (SCS) technologies found that high-frequency SCS using 10 kHz (HF10) exceeded lower-frequency, traditional SCS in response rate and pain relief. Further, this was achieved without the paresthesia that may cause discomfort with traditional SCS, the researchers reported in a scientific poster at the 31st Annual Meeting of the American Academy of Pain Medicine.

Traditional SCS low-frequency (~50 Hz) stimulation is an attempt to mask the sensation of pain with a tingling or buzzing sensation, known as paresthesia. Therefore, the therapeutic goal with traditional SCS is to cover the areas of pain with paresthesias, explained B. Todd Sitzman, M.D., M.P.H., medical director of Advanced Pain Therapy, PLLC, in Hattiesburg, Miss.

In contrast, “high-frequency HF10 therapy utilizes a stimulation frequency that is orders of magnitude higher than traditional SCS,” Sitzman said. “HF10 therapy does not produce paresthesias and achieves superior back and leg pain relief.”

More importantly, HF10 therapy was shown to be superior to traditional SCS in all of the study-related primary and secondary endpoints, including response rate and pain relief. The magnitude of back pain relief was consistent with previous European research of HF10 therapy (Van Buyten et al, Neuromodulation 2013;16(1):59-65; Al-Kaisy et al, Pain Med 2014;15(3):347-54).

The use of SCS, introduced in 1967, has expanded as a treatment for difficult pain syndromes, encompassing peripheral neuropathies, complex regional pain syndromes, peripheral vascular disease and other disorders in addition to failed back surgery syndrome (Deer, Techniques in Regional Anesthesia and Pain Management 1998 2(3):161-7).

Traditional low-frequency SCS systems are widely used in clinical practice. However, the scientific literature indicates that achieving back pain coverage with traditional SCS is technically difficult and is often not sustained over time. (North et al, Neurosurgery 2005;57(5):990-62005; Frey et al, Pain Physician 2009;12(2):379-97). According to one report, 71 percent of patients who received an implant with traditional SCS experienced discomfort from the stimulation of paresthesia (Kuechmann et al, Abstract. Pain in Europe VI [EFIC], Lisbon, Portugal: Sept. 9-12, 2009). In the current study, 44 percent of patients receiving traditional SCS reported uncomfortable stimulation.

The study was a prospective, randomized, multicenter, comparative trial of the investigational HF10 vs. the standard SCS therapy, designed in consultation with and monitored by the FDA. Institutional review board approval was obtained for each study site.

The 12-month follow-up data indicated that the responder rate with HF10 therapy was twice that with traditional SCS for both back and leg pain. Also, the average degree of pain relief with HF10 therapy was more than 50 percent greater than with traditional SCS. The level-1 evidence with 12-month follow-up meets today’s rigorous standards for evidence-based healthcare and complies with regulatory agency and payer preference for comparative effectiveness, the investigators said.

“These results provide important comparative effectiveness data for healthcare providers and clinically relevant information for pain physicians, patients and payers,” Sitzman said.

At present, HF10 therapy is investigational in the United States. The manufacturer of the device, Nevro Corp., which funded this study, anticipates obtaining market approval from the FDA by mid-2015.

Poster 140 – Rationale for the SENZA-RCT Study Design and Comparative Outcomes

About AAPM

The American Academy of Pain Medicine is the premier medical association for pain physicians and their treatment teams with over 2,500 members. Now in its 32nd year of service, the Academy’s mission is to optimize the health of patients in pain and eliminate pain as a major public health problem by advancing the practice and specialty of pain medicine through education, training, advocacy and research. Information is available on the Academy’s website at http://www.painmed.org.

via High-Frequency Surpasses Traditional Spinal Cord Stimulation in First Controlled Trial Comparing Technologies.

Stem Cell Therapy Holds New Promise for Patients with Dysautonomia – Autonomic Specialists Community

January 5, 2015 at 11:48 am , by 

Recent advances in stem cell research have led to exciting new treatment possibilities for patients with dysautonomia.

Exactly why people develop dysautonomia has eluded researchers for decades. Researchers from the University of Oklahoma have determined that one causative agent for dysautonomia is antibodies formed against certain receptors found on nerve cells1. In other words, for many patients, dysautonomia is actually an autoimmune condition. IVIG (gamma globulin) is increasingly being used to treat dysautonomia. Complications following IVIG are very unusual, but heart attack, stroke and renal failure have been reported. Stem cells are a potential alternative to IVIG for treatment of a broad array of autoimmune conditions.

Multiple System Atrophy (MSA) is one form of dysautonomia for which stem cells have shown promise as a therapy. Mesenchymal stem cell (MSC) therapy has been studied in a rat model for MSA2. The first human study was published in 20083 and found MSC therapy helpful for treating MSA. A randomized trial of the use of MSC therapy for MSA was published in 2012 and demonstrated a delay in disease progression4. A recently published study5 found that MSC treatment modulates cortical thickness in patients with MSA, which, the authors infer, may have implications for MSC treatment application for other cognitive disorders.

Autonomic Specialists are now investigating the application of stem cells in treatment of Dysautonomia. Treatment is offered as part of an IRB approved study. If you would like more information or to find out if you might be a candidate for Mesenchymal stem cell treatment, please contact us through this web form (click here) or call us at (949) 247-8877.

via Stem Cell Therapy Holds New Promise for Patients with Dysautonomia – Autonomic Specialists Community.