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.

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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

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/