Music therapy benefits fibromyalgia patients

May 27, 2011,

 The low cost, easy implementation, numerous advantages, and the fact that patients can get involved in their treatment at home are some of the many advantages of this technique.

Researchers have stated that "further empirical research studies are needed to address other physiological variables associated with the well-being generated by these two techniques, and that analyse patients'' self-efficiency and personal power to get involved in their own treatment.
http://articles.timesofindia.indiatimes.com/2011-05-27/health/29591220_1_music-therapy-patients-researchers

Progenics Announces Results of Methylnaltrexone Phase 3 Safety Study in Chronic, Non-Malignant Pain Patients

 May 20, 2011 

Progenics Pharmaceuticals, Inc. today provided analyses of safety and efficacy endpoints from the 1,034-patient, one-year phase 3 safety study of methylnaltrexone bromide subcutaneous injection in non-malignant pain patients with opioid-induced constipation (OIC). At a fixed dose of 12 mg, the drug was shown to be generally safe and well tolerated, with a safety profile similar to that from a previously reported, shorter-duration efficacy study in non-malignant pain patients. The results are being presented at the annual meeting of the American Pain Society in Austin, TX, May 19-21, 2011.

Patients experienced consistent results across all monthly intervals, and 34.1% of methylnaltrexone 12 mg subcutaneous injections resulted in bowel movements within four hours during the treatment period. In addition, patient subjective assessments showed statistically significant improvements from baseline for a reduction in straining and for the number of bowel movements accompanied by the sensation of complete evacuation.

"This study yielded safety and efficacy data that support the potential utility of subcutaneous methylnaltrexone for use by patients who take opioids for pain over extended periods," said Robert Israel, M.D., senior vice president of medical affairs at Progenics.  "We found that the four-hour response rate remained durable over the course of the one-year study period. In addition, the assessed safety of long-term methylnaltrexone use was consistent with previously reported results of the three-month phase 3 efficacy study in non-malignant pain patients with OIC."

The safety study included patients who had a history of chronic, non-malignant pain (including back pain, joint/extremity pain, neurologic/neuropathic pain and fibromyalgia) and who experienced constipation resulting from opioid pain medication use for at least one month prior to screening. Of the 1,034 patients who received at least one dose of methylnaltrexone, 624 patients were treated for six months or more, and 477 completed the 48-week study and post-treatment follow-up periods. Patients took a median of six subcutaneous injections per week of methylnaltrexone 12 mg for up to 48 weeks. There were no observed unexpected safety signals, or cases of gastrointestinal perforation in the study. Pain scores and opioid use data confirmed that methylnaltrexone 12 mg subcutaneous injection did not interfere with analgesia or cause opioid withdrawal symptoms.

These safety data, together with previously announced efficacy data, complete the major data packages for a supplemental New Drug Application being prepared for submission to the U.S. Food and Drug Administration by the end of June. In this application, Progenics and its commercialization partner, Salix Pharmaceuticals (Nasdaq:SLXP), plan to seek approval for subcutaneous methylnaltrexone in non-malignant pain patients suffering from opioid-induced constipation. Methylnaltrexone currently is approved and marketed as RELISTOR^® for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

http://www.istockanalyst.com/business/news/5167878/progenics-announces-results-of-methylnaltrexone-phase-3-safety-study-in-chronic-non-malignant-pain-patients

Opioids Remain The Mainstay of Chronic Pain Treatment

May 18, 2011 – Pain is a disabling symptom that can occur at any point in the course of an illness. Since pain considerably affects day to day life, its management offers considerable challenge for physicians. Inadequate pain control remains a major problem across the world. Pain relief medications are dominated by NSAIDs followed by opioids. Long acting opioids are used in the relief of moderate to severe pain which require treatment for several days. Oral Long Acting Opioids (LAOs) are also an option to treat acute pain in non-dependant patients. Opioids are prescribed when pain cannot be adequately controlled with an NSAID.

All NSAIDs/Cox-2 inhibitors have cardiovascular and renal side-effects, and the older NSAIDs have severe gastrointestinal ones too. Therefore in cases of acute and chronic opioids continue to be the mainstay of therapy. However, this market is struggling to generate sales growth against a background of weak pipelines and generic competition.

In 2010, the global opioids market was approximately $11.2 billion, representing a compound annual growth rate (CAGR) of 2.4% between 2002 and 2010. By 2017, the global opioids market is forecast to reach $13.2 billion, indicating a CAGR of 2.8% between 2010 and 2017. The market for pain management drugs is focused on enhancement of available dugs with the development of extended release formulations and drug combinations.

For Sample Pages, please click or add the below link to your browser:
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In an effort to minimize the risk of misuse, abuse, addiction and overdose opioids are made available through a Risk Evaluation and Mitigation Strategy (REMS) program. In order to ensure that the benefits of the drugs outweigh the risks of use in patients, the FDA had notified opioid drug manufacturers to have REMS. Under this program, pharmacies, distributors, and medical care providers who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute opioid drugs.

GBI Research, the leading business intelligence provider, has released its latest research,
“Opioids Market to 2017 - Steady Uptake of Oxycontin and High Incidence Of Diseases Such As Cancer And Arthritis to Drive the Market”, which provides insights into global Opioids market and market forecast until 2017.

Report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

The report provides an in-depth analysis of the top five therapeutic indications for which often opioids are prescribed which includes fibromyalgia, neuropathic pain, cancer pain, osteoarthritis pain, rheumatoid arthritis pain, low back pain and post operative pain. The report also examines the global opioids treatment usage patterns for the covered indication. In addition, the report also includes insights into the opioids R&D pipeline
http://www.prlog.org/11496663-opioids-market-to-2017.html

Brain, Behavioral Effects of Duloxetine Observed in Patients with Chronic Low Back Pain

Debra Hughes : May 21, 2011

 

AUSTIN, TX—Initial analysis of the effects of duloxetine vs. placebo in patients with chronic low back pain indicates duloxetine has both brain and behavioral effects in this population, Kevin A. Johnson, of Stanford University School of Medicine, Palo Alto, CA, and colleagues reported during the American Pain Society's 30th Annual Scientific Meeting. These effects were evident on structural MRIs, which indicated changes in gray matter with both duloxetine and placebo, including increases in frontal cortex regions.

The U.S. Food and Drug Administration approved  duloxetine, a serotonin-norepinephrine reuptake inhibitor used for a variety of indications—including depression, diabetic peripheral neuropathy, and fibromyalgia—in November 2010 to treat discomfort from lower back pain.The investigators conducted a randomized, double-blind, placebo-controlled crossover study utilizing clinical assessments to examine the effects of duloxetine and placebo. Additionally, MRI was used to detect possible brain effects of duloxetine and placebo. Patients with at least 6 months of back pain (no radicular symptoms), a minimum pain rating of 4 on a scale of 1-10 for two weeks prior to enrollment, and no current use of pain medication (except acetaminophen) were eligible to enter the study.
Patients were randomized to duloxetine 30mg/day for 1 week, followed by 60mg/day for 5 weeks or matching placebo. Clinical assessments occurred at baseline and at Weeks 1, 2, and 6 of each medication period. Week 6 was the crossover point, where patients were switched to duloxetine or placebo. Additional at-home measures were collected. Clinical measures included basic medical assessments, a battery of pain-related questionnaires, and mood and depression ratings. Data have been collected to date on 18 patients.
A significant change in daily pain ratings was found at the end of the duloxetine period, particularly for patients randomized initially to the placebo treatment group (weekly mean P<0.05 at weeks 3 and 6 for duloxetine vs. placebo and P<0.01 at weeks 4 and 6). Most patients (15/18) had minimal to mild depression (Beck Depression Inventory <19) upon study enrollment; at 6 weeks, no significant increases in overall score were noted in the study. Disrupted sleep patterns and loss of energy were the most frequently rated sub-scale items throughout the study. No significant difference between drug and placebo in overall score was noted on the Brief Pain Inventory. On sub-items, significant improvement was seen with duloxetine in worst pain (P=0.009), least pain (P=0.019), average pain (P=0.007), and current pain (P=0.009).
The investigators concluded that given the large individual variability in pain ratings found within an individual treatment period and in response to a particular treatment, accounting for such individual variability may help refine behavioral and neuroanatomical analysis.
http://www.clinicaladvisor.com/brain-behavioral-effects-of-duloxetine-observed-in-patients-with-chronic-low-back-pain/article/203418/

Childhood abuse linked to chronic fatigue syndrome, fibromyalgia in women

May 17 2011
University of Toronto researchers have found that childhood physical abuse is associated with significantly elevated rates of functional somatic syndromes such as chronic fatigue syndrome, fibromyalgia and multiple chemical sensitivities among women.
“Women who reported they had been physically abused as children have twice the odds of chronic fatigue syndrome and multiple chemical sensitivities, and 65 per cent higher odds of fibromyalgia” said lead investigator Professor Esme Fuller-Thomson, who holds the Sandra Rotman Chair at U of T’s Factor-Inwentash Faculty of Social Work and Department of Family and Community Medicine.
“These findings persisted even after controlling for potentially confounding factors such as other adverse childhood experiences, age, race, mental health and adult socioeconomic status.”
The study examined statistics from a regional subsample of the 2005 Canadian Community Health Survey involving 7,342 women, 10 per cent of whom reported being physically abused as children. A minority of women reported they had been diagnosed by a health professional with chronic fatigue syndrome (1.3 percent), fibromyalgia (2.5 percent), or multiple chemical sensitivities (2.7 percent).
Co-author Joanne Sulman, from the Department of Social Work at Mount Sinai, said the research not only points to an association between childhood physical abuse and these disorders, but also explores the contribution of confounding psychosocial factors such as other childhood adversities, adult health behaviours and mental health.
The research will be published in the Journal of Aggression, Maltreatment and Trauma.
http://news.bioscholar.com/2011/05/childhood-abuse-linked-to-chronic-fatigue-syndrome-fibromyalgia-in-women.html

Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study.

Author: Elena CalandrePiedad Morillas-ArquesRocio Molina-BareaCarmen Rodriguez-lopezFernando Rico-Villademoros
Credits/Source: BMC Musculoskeletal Disorders 2011, 12:95

Although trazodone is frequently used by fibromyalgia patients, its efficacy on this disease has not been adequately studied. If effective, pregabalin, whose beneficial effects on pain and sleep quality in fibromyalgia have been demonstrated, could complement the antidepressant and anxiolytic effects of trazodone.
The aim of the present study was to assess the effectiveness of trazodone alone and in combination with pregabalin in the treatment of fibromyalgia.

Methods:
This was an open-label uncontrolled study.Trazodone, flexibly dosed (50-300 mg/day), was administered to 66 fibromyalgia patients during 12 weeks; 41 patients who completed the treatment accepted to receive pregabalin, also flexibly dosed (72-450 mg/day), added to trazodone treatment for an additional 12-week period. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI) the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients'Global Improvement scale (PGI).
Emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test.

Results:
Treatment with trazodone significantly improved global fibromyalgia severity, sleep quality, and depression, as well as pain interference with daily activities although without showing a direct effect on bodily pain.
After pregabalin combination additional and significant improvements were seen on fibromyalgia severity, depression and pain interference with daily activities, and a decrease in bodily pain was also apparent. During the second phase of the study, only two patients dropped out due to side effects.

Conclusions:
Trazodone significantly improved fibromyalgia severity and associated symptomatology.
Its combination with pregabalin potentiated this improvement and the tolerability of the drugs in association was good.Trial registration: This trial has been registered with ClinicalTrials.gov number NCT-00791739.

http://7thspace.com/headlines/382593/trazodone_plus_pregabalin_combination_in_the_treatment_of_fibromyalgia_a_two_phase_24_week_open_label_uncontrolled_study.html

Sodium Oxybate Reduces Pain in Patients with Moderate and Severe Fibromyalgia Symptoms

Debra Hughes : May 21, 2011

 

AUSTIN, TX—Sodium oxybate was shown to be effective in patients with both moderate to severe fibromyalgia symptoms, according to an analysis presented at the American Pain Society's 30th Annual Scientific Meeting. Sodium oxybate is not currently approved for the treatment of fibromyalgia.

I. Jon Russell, MD, PhD, of the Texas Health Sciences Center, San Antonio, TX, and colleagues from Oregon Health & Science University, Portland, OR, and Jazz Pharmaceuticals, Inc., Palo Alto, CA, analyzed pooled data from two 14-week, Phase 3, double-blind, randomized, placebo-controlled trials to determine the proportions of responders (≥30% reduction on a 0–100mm pain visual analogue scale [VAS]) by moderate (VAS ≥50 to <70) or severe (≥70) pain and by moderate or severe disease, based on clinician global impression of severity (CGI-S) at baseline. A total of 1,121 patients were randomized in the two trials, and were given placebo, sodium oxybate 4.5g or 6g in equal, divided doses at bedtime and 2.5–4 hours later. The data were analyzed by baseline-observation-carried-forward (BOCF) and last-observation-carried-forward (LOCF) methods.
In patients with pain VAS ≥50 to <70, approximately 51% and 54% receiving sodium oxybate 4.5g and 6g, respectively, were responders vs. placebo (29%; P<0.001, LOCF). In patients with pain VAS ≥70, 45% (P=0.013) and 56% (P<0.001), respectively, were responders vs. placebo (33%, LOCF). Subgroup analysis based on CGI-S demonstrated similar efficacy in both dose groups vs. placebo for both the moderately ill/less severe (53% for both doses vs. 35% for placebo; P<0.001, LOCF) and markedly ill/more severe, 41% for sodium oxybate 4.5g (P=0.004) and 57% (P<0.001) for 6 g vs. 25% for placebo(LOCF) groups. BOCF analyses by baseline pain and CGI-S also demonstrated statistically significant efficacy of both sodium oxybate doses vs. placebo (overall P<0.001 for moderately ill/less severe patients and P=0.002 for markedly ill/more severe patinets). The most common adverse events (≥5% in any sodium oxybate treatment group and at least twice the rate of placebo) were nausea, dizziness, vomiting, anxiety, and fatigue.
Dr. Russell et al. concludedthese analyses demonstrate that in patients with fibromyalgia, sodium oxybate demonstrates efficacy for the rduction of pain regardless of whether pain and disease severity were moderate or severe at baseline. Greater proportions of patients having moderate and severe pain, and moderate and severe disease severity achieved ≥30% reduction in pain with sodium oxybate at doses of 4.5g and 6g compared with placebo.
http://www.empr.com/sodium-oxybate-reduces-pain-in-patients-with-moderate-and-severe-fibromyalgia-symptoms/article/203417/

Milnacipran Safe, Effective for Long-Term Treatment of Fibromyalgia

Jenny Ko, PharmD

May 20, 2011

 

AUSTIN, TX—Sustained long-term efficacy and tolerability of milnacipran—in some cases, exceeding three years of continuous usage—is supported in the treatment of patients with fibromyalgia, according to results of an open-label study presented during the American Pain Society's 30th Annual Scientific Meeting.

Fibromyalgia is a chronic disorder characterized by widespread pain and other symptoms that adversely impact function and health-related quality of life. For that reason, durable efficacy is an important treatment goal, noted Lesley Arnold, MD, from the University of Cincinnati College of Medicine, Cincinnati, OH, and colleagues.
To determine long-term efficacy of milnacipran, which is approved for the management of fibromyalgia, treatment effects were evaluated in 1,227 patients in a safety and efficacy study over a period that could exceed three years. Eligible patients were those with fibromyalgia who had successfully completed previous studies of milnacipran. The multicenter, open-label, flexible-dose study comprised a two-week washout period, a two-week dose-escalation period (to milnacipran 100mg/day), an 8-week stable-dose period (at milnacipran 100mg/day), and a flexible-dose period (milnacipran 50–200mg/day) for the remainder of the study. Key efficacy outcomes included 24-hour visual analog scale (VAS) and weekly recall pain (0–100 scale), Patient Global Impression of Change (PGIC), Patient Global Disease Status (PGDS), SF-36 Physical Component Summary (SF-36 PCS), and the Brief Pain Inventory (BPI).
Of the 1,227 patients, 47.7% were considered completers; 206 patients reached the final visit and 379 were enrolled when the study was terminated. Efficacy results were reported as mean changes from study baseline following the two-week washout period. At the final visit, patients treated with milnacipran demonstrated a mean (SEM) improvement from baseline in 24-hour VAS recall pain scores of 23.1 points (1.82) (observed cases). Improvements in VAS weekly recall pain, BPI scores, global status (PGIC, PGDS), and physical function (SF-36 PCS) were all observed with milnacipran treatment.
Over the three-year study, the most common treatment-emergent adverse events were nausea (25.9%), headache (13.4%), hypertension (11.2%), and sinusitis (10.4); 20.9% of patients discontinued the study due to these events, primarily nausea.

http://www.clinicaladvisor.com/milnacipran-safe-effective-for-long-term-treatment-of-fibromyalgia/article/203390/

GW Pharmaceuticals and Sativex

17 May 2011 GW Pharmaceuticals, the Cambridge pharma company marketing drugs based on cannabis, has turned a £2.7m loss last time into a net pre-tax profit of £3.1m in the six months to March 31.
The turnround was spurred by an upsurge in total revenues, which increased 45 per cent to £16.6m (H1 2010: £11.4m) including milestone receipts of £5.1m (£nil) and increased Sativex sales of £1.9m (£0.9m).
Cash and short term deposits at period-end increased to £28.3m (£20.4m).
GW’s lead product, Sativex, is a cannabinoid mouth spray identical to whole-plant marijuana in liquid form and was developed for multiple sclerosis patients, who can use it to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms.
Sativex is also being prescribed to alleviate pain due to cancer and has been researched in various models of peripheral and central neuropathic pain.
During the half-year, a licence agreement was signed with Novartis to commercialise Sativex in Australasia, Asia (excluding Japan/China), the Middle East (excluding Israel) and Africa.
It has been recommended for approval in Germany, Italy, Denmark, Sweden, Austria and the Czech Republic. Launches are expected this year in Germany, Denmark and Sweden following launch in Spain in March.
The US is a massive potential market for the company: A Phase III cancer pain programme is underway, fully funded by US partner, Otsuka.

Two Phase IIa clinical trials of novel cannabinoid medicine in diabetes and metabolic disease have also begun.

Positive pre-clinical data in epilepsy, glioma, breast cancer and other conditions continue to be generated as part of Otsuka research collaboration.
Dr Geoffrey Guy, GW’s chairman, said: “GW has delivered another robust set of financial results, with substantially increased revenues yielding a profit for the period and a strong cash position.
“With Sativex now launched in the UK and Spain, an increasing number of additional European approvals and launches for Sativex now expected and the recent agreement with Novartis to commercialise Sativex across a broad region of the world, Sativex should provide GW with a platform for significant growth in the coming years.

“In parallel we have embarked on a substantial Phase III programme for Sativex in cancer pain, a major market opportunity, a Phase II clinical programme for a novel cannabinoid medicine in diabetes and we continue to generate highly promising data in our earlier stage pipeline.
“With regular Sativex launches now taking place, GW has entered a new phase in the evolution of the company and we believe that our prospects for commercial success with Sativex together with a highly promising and maturing pipeline provide confidence for the remainder of 2011 and beyond.”
http://www.businessweekly.co.uk/biomedtech-/11836-cannabis-company-up-to-speed-as-cash-starts-to-flow

Acadia Pharma awarded grant from NIH for development of novel ER-beta agonists

Acadia Pharmaceuticals Inc. a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, announced that it has been awarded a grant from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH), for the development of novel Estrogen Receptor beta (ER-beta) agonists for the treatment of neuropathic pain. The grant provides funding of up to $2.4 million and was awarded under the NINDS Fast-Track Small Business Innovative Research Co-operative Programme in Translational Research that supports the identification and preclinical testing of new therapeutics for neurological disorders.

“We are delighted to be awarded this NINDS grant, which allows us to advance our promising ER-beta program in the area of neuropathic pain and provides important recognition of our scientific discoveries,” said Uli Hacksell, PhD, chief executive officer of Acadia. “Our ER-beta compounds also offer the potential for an innovative disease-modifying approach to the treatment of Parkinson's disease, and our initial studies in this area have been supported by grants from The Michael J Fox Foundation.”

Studies have shown that estrogen modulates many cerebral functions such as mental state, mood, cognition and perception of pain. Estrogen stimulates both ER-alpha and ER-beta receptors. Acadia researchers have identified novel and selective ER-beta agonists that may address the symptoms of chronic, inflammatory and neuropathic pain while avoiding the side effects associated with activating ER-alpha receptors. Pursuant to the grant, Acadia will initially examine the efficacy of selected proprietary ER-beta compounds in preclinical models and intends to subsequently conduct preclinical development studies required in support of potential future clinical studies.

Neuropathic pain is a debilitating disorder caused by damage or dysfunction of the nervous system and originates from many diverse sources including diabetic and hereditary neuropathies, herpes, chemotherapy, physical traumas and surgery. Current first-line medications are limited by variable efficacy and adverse effects. There is a major unmet medical need for novel, safe and effective drugs to treat neuropathic pain.

LYRICA: Pfizer sales report

May 03, 2011 : Kevin Grogan
Pfizer has reported flat sales for the first quarter while net income rose 10% to $2.22 billion, beating analyst estimates.
Lyrica, Prevnar on the rise

Sales of Lyrica (pregabalin), for epilepsy, fibromyalgia and neuropathic pain, increased 14% to $826 million,


As for products Pfizer got hold of through its acquisition of Wyeth, the antidepressant Effexor (venlafaxine) contributed just $204 million, down 72% as a result of generic competition,


Chief executive Ian Read said he was pleased "not only with our solid financial performance during the first quarter despite the loss of exclusivity of several products in the USA and other geographies, but also with our ability to enhance shareholder value through various initiatives", notably a share repurchase programme. He added that Pfizer's emerging markets unit delivered 8% operational growth, "driven by many of our priority countries, notably China, and continued to benefit from our ongoing targeted investment".
http://www.pharmatimes.com/Article/11-05-03/Healthy_quarter_for_Pfizer_no_news_of_further_sell-offs.aspx

EXERCISE: Virtual reality exposure therapy as treatment for pain catastrophizing in fibromyalgia patients: proof-of-concept study

Author: Linzette MorrisKaren Grimmer-SomersBruce SpottiswoodeQuinette Louw
Credits/Source: BMC Musculoskeletal Disorders 2011, 12:85

Albeit exercise is currently advocated as one of the most effective management strategies for fibromyalgia syndrome (FMS); the implementation of exercise as a FMS treatment in reality is significantly hampered by patients'poor compliance. The inference that pain catastrophizing is a key predictor of poor compliance in FMS patients, justifies considering the alteration of pain catastrophizing in improving compliance towards exercises in FMS patients.
The aim of this study is to provide proof-of-concept for the development and testing of a novel virtual reality exposure therapy (VRET) program as treatment for exercise-related pain catastrophizing in FMS patients.

Methods:
Two interlinked experimental studies will be conducted. Study 1 aims to objectively ascertain if neurophysiological changes occur in the functional brain areas associated with pain catastrophizing, when catastrophizing FMS subjects are exposed to visuals of exercise activities.
Study 2 aims to ascertain the preliminary efficacy and feasibility of exposure to visuals of exercise activities as a treatment for exercise-related pain catastrophizing in FMS subjects. Twenty subjects will be selected from a group of FMS patients attending the Tygerberg Hospital in Cape Town, South Africa and randomly allocated to either the VRET (intervention) group or waiting list (control) group.
Baseline neurophysiological activity for subjects will be collected in study 1 using functional magnetic resonance imaging (fMRI). In study 2, clinical improvement in pain catastrophizing will be measured using fMRI (objective) and the pain catastrophizing scale (subjective).DiscussionThe premise is if exposing FMS patients to visuals of various exercise activities trigger the functional brain areas associated with pain catastrophizing; then as a treatment, repeated exposure to visuals of the exercise activities using a VRET program could possibly decrease exercise-related pain catastrophizing in FMS patients.
Proof-of-concept will either be established or negated. The results of this project are envisaged to revolutionize FMS and pain catastrophizing research and in the future, assist health professionals and FMS patients in reducing despondency regarding FMS management.
Trial registration: PACTR201011000264179
http://7thspace.com/headlines/380906/virtual_reality_exposure_therapy_as_treatment_for_pain_catastrophizing_in_fibromyalgia_patients_proof_of_concept_study_study_protocol.html

Cymbalta approved by Health Canada for low back pain

TORONTO, April 29 /CNW/ - Eli Lilly Canada announced today that Health Canada has approved Cymbalta^® (duloxetine HCl) for the management of chronic low back pain (CLBP).  The recommended dose is 60 mg once daily.
The approval is based on the results of two randomized, double-blind, 12-13 week, placebo-controlled studies in 637 adult patients with a clinical diagnosis of CLBP with pain present on most days for at least 6 months and no sign of radiculopathy or spinal stenosis.¹ The primary efficacy endpoint in both studies was a reduction in pain severity as measured by the Brief Pain Inventory (PBI) 24-hour average pain rating on the 11-point Likert scale (0 = no pain; 10 = worst possible pain). In both studies, patients taking Cymbalta 60 mg once daily experienced significantly greater pain reduction compared to placebo.  In addition, some patients reported pain reduction as early as one week into the trial after starting the 60 mg dose, which continued throughout the study.
Cymbalta has been evaluated for safety in 698 patients with CLBP. The most common side effects reported in the two studies included nausea, insomnia, somnolence, constipation, dry mouth, fatigue and dizziness.¹

About Cymbalta
Cymbalta is a potent and balanced serotonin and norepinephrine reuptake inhibitor (SNRI), which targets two chemical messengers in the brain believed to play a role in sensitivity to pain - serotonin and norepinephrine. While the mechanism of action of duloxetine in humans is not fully known, scientists believe its effect on pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Cymbalta is now indicated in Canada for three distinct pain conditions: CLBP, neuropathic pain associated with diabetic peripheral neuropathy and fibromyalgia.  It is also indicated in Canada for the symptomatic relief of major depressive disorder (MDD) and generalized anxiety disorder (GAD).
Duloxetine is contraindicated in patients who are allergic to it, who have liver disease resulting in hepatic impairment, who are taking a monoamine oxidase inhibitor (MAOI) including linezolid and methylene blue, thiorazidine, potent CYP1A2 inhibitors (e.g. fluvoxamine), and some guinolone antibiotics (e.g. ciprofloxacin or enoxacine), who have uncontrolled narrow glaucoma, or who have severe kidney disease.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.  Eli Lilly Canada, headquartered in Toronto, Ontario, employs close to 500 people across the country.  Additional information about Eli Lilly Canada can be found at http://www.lilly.ca/.

^® Registered trademark owned by Eli Lilly and Company; used under license.

http://www.digitaljournal.com/pr/292994#ixzz1LEEk6UYb

Cymbalta generic version blocked

Associated Press, 04.27.11,

INDIANAPOLIS -- Eli Lilly and Co. said Wednesday that a federal court is blocking low-cost generic versions of Cymbalta from the market until the patents supporting the drug expire.

Eli Lilly  said the order from the U.S. District Court for the Southern District of Indiana will stop generic competition for Cymbalta, Lilly's second best-selling drug, until at least June 2013. The company said the court initially entered a judgment in its favor on March 21. As part of Wednesday's ruling, the defendants are required to inform the Food and Drug Administration that they are not seeking approval for generic Cymbalta until the patents expire.

Eli Lilly said the litigation has been dismissed and no appeal is possible.

Cymbalta, or duloxetine, is approved to treat depression, fibromyalgia and musculoskeletal pain. The company reported $2.77 billion in U.S. sales in 2010. That was 80 percent of worldwide Cymbalta sales, which totaled $3.48 billion.
http://www.forbes.com/feeds/ap/2011/04/27/business-health-care-us-eli-lilly-cymbalta_8438430.html