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The Launch of Pfizer's Pregabalin and Eli Lilly's Duloxetine Will Improve Awareness of Diagnosis and Treatment Among Primary Care Practitioners
Quote:
WALTHAM, Mass., Nov. 17 /PRNewswire/ -- Decision Resources, Inc., one of
the world's leading research and advisory firms focusing on pharmaceutical and
health care issues, finds that the launch of more-expensive emerging agents
with regulatory approval for neuropathic pain will drive growth in the key
neuropathic pain markets. Market growth will reflect a shift in treatment
practices as physicians who historically relied on relatively inexpensive,
off-label generic therapies turn to more-expensive, approved drugs.
"Drug manufacturers are hoping to grab share in this growing market," said
Elana Feldman, analyst at Decision Resources. "After witnessing the success of
Pfizer's Neurontin, one of the only drugs currently approved for neuropathic
pain, companies are realizing that they can boost sales for products
traditionally indicated for other diseases by pursuing supplementary approval
for neuropathic pain."
The new Pharmacor study entitled Neuropathic Pain: Painful Diabetic
Neuropathy, Postherpetic Neuralgia, and HIV-Related Neuropathic Pain also
finds that Pfizer's antiepileptic drug pregabalin and Eli Lilly's
antidepressant duloxetine will improve awareness among physicians,
particularly primary care practitioners, of neuropathic pain diagnoses and
treatments. This awareness will lead to a steady increase in the number of
diagnosed and drug-treated neuropathic pain patients.
Neuragen RL is a proprietary natural medication for treating neuropathic pain by topical application.
Extensive use of Neuragen RL, including a controlled clinical trial, demonstrates its effectiveness as a topical analgesic which quickly relieves neuropathic pain in a variety of situations without harmful side effects. Most topical analgesics now on the market are useful for muscle aches and related inflammatory pain, but not for neuropathic pain – Neuragen RL helps for pain the others don’t touch. Neuragen RL does not numb the area of application and can be applied repeatedly. The key active ingredient of Neuragen RL is a purified variety of geranium oil, carefully isolated from years of clinical testing.
Has anyone has success using acupuncture for the treatment of painful peripheral neuropathy? I feel for patients who are already on multiple medications its a useful treatment option to offer before adding in yet another tablet.
Sandra
Sandra,you came upwith a good idea.Accupuncture is a good adjunct therapy which a lot of doctors(me included)underutilize.I am trying cymbalta for the pain-1 60 mg tablet q24h.I try the antiepileptics with fair results.I also go with capsaicin which is a topical analgesic derived from a hot pepper plant.This works by depleting substance P.
I also go with capsaicin which is a topical analgesic derived from a hot pepper plant.This works by depleting substance P.
my patients tell me they can only purchase this topically in WA in combination with topical glucosamine...a GP reportedly also told a patient it was available by prescription in WA either...anyone else has any luck getting it?
Neuragen RL is a proprietary natural medication for treating neuropathic pain by topical application.
Extensive use of Neuragen RL, including a controlled clinical trial, demonstrates its effectiveness as a topical analgesic which quickly relieves neuropathic pain in a variety of situations without harmful side effects. Most topical analgesics now on the market are useful for muscle aches and related inflammatory pain, but not for neuropathic pain – Neuragen RL helps for pain the others don’t touch. Neuragen RL does not numb the area of application and can be applied repeatedly. The key active ingredient of Neuragen RL is a purified variety of geranium oil, carefully isolated from years of clinical testing.
Today I had a fellow with a severely painful case of diabetic neuropathy.I wanted to start him on cymbalta.Then I saw that his liver enzymes(SGOT and SGPT) were markedly elevated.I did not put him on that.Be careful regarding the newer meds with people with liver problems.
Accupuncture can be a very useful therapy for people who have "gone through the mill" regarding treatments for diabetic neuropathy.It seems that this is a very trying malady to treat.
I know some cases of accupuncture and accupressure helping difficult neuropathic pain. I also have experience with a Dr. Lee at LSU's Pennington Biomedical Research Institute/ Neuromedical Center in Baton Rouge, LA. He has a study and treatment program using Tai-Chi for treatment of neuropathic pain. I have a few patients who have benefitted from this Tai-Chi program. -John
Sorry, this appears to be an old discussion--
Still relevant, though. Neuropathy is difficult to treat successfully.
__________________
Dr. John G. Fasick II
Clinical Insructor, LSU School of Medicine
Advanced Foot & Ankle Center of East Jefferson footankledoc2@gmail.com
Last edited by Gibby : 6th February 2009 at 07:47 AM.
Reason: old thread
Press Release: Phase II Results For GSK1838262 (XP13512) Reported For Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
29 Apr 2009
Quote:
GlaxoSmithKline (NYSE:GSK) and XenoPort, Inc. (Nasdaq:XNPT) announced results from a Phase II clinical trial of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults. GSK1838262 did not demonstrate a statistically significant improvement on the primary endpoint when compared to placebo, based on the change from baseline to end of treatment on the Pain Intensity-Numerical Rating Scale (PI-NRS). The pregabalin active control arm also did not differentiate from placebo on this same endpoint. The failure of the study to demonstrate a statistically significant benefit on the primary endpoint may be a consequence of the unexpectedly high placebo response rate observed in the study.
This 14-week, double-blind, placebo-controlled study enrolled 421 patients who were diagnosed with either Type 1 or Type 2 diabetes mellitus with signs and symptoms of DPN. Patients were randomized to receive either 1200 mg/day, 2400 mg/day or 3600 mg/day of GSK1838262 administered in divided doses twice daily, 300 mg/day of pregabalin as an active control, administered in divided doses three times daily, or placebo.
Throughout the study, GSK1838262 was generally well tolerated; the two most frequently reported adverse events were dizziness and somnolence.
"Although we are disappointed that neither GSK1838262 nor pregabalin demonstrated a clear clinical benefit over placebo in this study, we will be evaluating the study results further in order to determine our next steps," said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicines Development Center.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, "A high placebo response is not uncommon in DPN studies, and this has been a contributing factor to several failed studies testing different drugs in this patient population. The failure of pregabalin in this study makes it difficult to draw definitive conclusions about the efficacy of GSK1838262. We are encouraged by the observation that all doses of GSK1838262 were generally well tolerated, particularly since the 3600 mg dose represents the highest dose tested in a study of this length."
GSK1838262 is a new chemical entity that is designed to improve upon the pharmacokinetics of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.
I know a rehab/occupational physician who does a lot of work with long term pain. He recommends use of "goanna" ointment, which is a non-prescription analgesic cream that has a fair dose of capsaicin in it. A cheaper way to access whatever benefit capsaicin can provide.
regards Phill
I have been using Acupuncture for Diabetic and non-Diabetic neuropathy. After the 1st session in most cases there has been some change. Within 3 sessions there has been significant change in the pain and less numbness reported as well.
There are 5 points in the foot and 3 on the leg that I find useful, only using these one leg only - this affects both legs though.
Is there anyone else who is having some success with Acupuncture?
BACKGROUND: A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN(R)" for the treatment of neuropathic pain.
METHODS: Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN(R) or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale.
RESULTS: There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN(R) led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN(R) reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN(R) group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed.
CONCLUSIONS: This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN(R), provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief.
Press Release:
ARCION THERAPEUTICS’ TOPICAL GEL CANDIDATE, ARC‐4558, DEMONSTRATES SIGNIFICANT
PAIN REDUCTION IN PHASE 2b TRIAL FOR PAINFUL DIABETIC NEUROPATHY (PDN)
Quote:
BALTIMORE, MD – July 20, 2010 - Arcion Therapeutics, a venture backed clinical stage biotechnology
company developing topical therapies for chronic pain, today announced top-line results from a
successful Phase 2b double-blind, randomized, placebo-controlled clinical trial of its lead topical pain
candidate, ARC-4558, in adult patients with painful diabetic neuropathy (PDN). Arcion recently held an
End of Phase 2 meeting with the United States Food and Drug Administration (FDA) and the ARC-4558
program is now poised to enter Phase 3 studies. ARC-4558 is a 0.1% gel formulation of clonidine
hydrochloride for topical administration.
The study results successfully demonstrated therapeutic potential for treating PDN with ARC-
4558 by targeting abnormal nerve signaling at the level of the skin with a 0.1% topical gel formulation
of clonidine. ARC-4558 was most effective in reducing pain in subjects with evidence of preserved
nociceptors (nerve fibers responsible for pain signaling) in the skin. In subjects with at least minimal
nociceptor function, ARC-4558 was significantly more effective in reducing pain than placebo (p<0.05).
The significance of the response increased with higher levels of nociceptors in the subject’s skin
(p<0.005). ARC-4558 did not demonstrate efficacy in subjects lacking evidence of preserved nociceptor
function.
The ITT (intent to treat) population was comprised of a mix of subjects in which about half
had little or no nociceptor preservation and therefore the pooled results were not significant. Plasma
levels of clonidine were consistently low or undetectable. No serious or severe adverse events were
attributable to ARC-4558 treatment and the topical formulation was well-tolerated at the site of skin
application.
“The top-line data reported today for ARC-4558 provide strong support for Arcion’s
fundamental approach of applying therapies topically to relieve neuropathic pain by targeting nerve
signaling at the level of the skin,” said James Campbell, M.D., President and CEO of Arcion. “Through
this study, we identified a simple, predictive clinical test to identify non-responders to ARC-4558,
which should enable us to optimize subject enrollment in future studies. Based on our successful End
of Phase 2 meeting with the FDA, we believe ARC-4558 will be the first PDN treatment indicated to
treat patients who have demonstrable functional nociceptors in the skin. The full Phase 2b results will
be submitted for future peer review and we look forward to advancing the ARC-4558 program in Phase
3 studies.”
Michael C. Rowbotham, M.D., Adjunct Professor of Neurology and Anesthesia and Director,
UCSF Pain Clinical Research Center, commented, "Painful diabetic neuropathy is frequently a
debilitating condition that severely impacts a patient’s quality of life and ability to carry out normal
day-to-day functions. There are approved therapies to control the pain, but issues of tolerability and
efficacy seriously limit their usefulness. A novel mechanism-based topical treatment with a low
liability of systemic side effects has promise to advance significantly the treatment of this condition
and improve the quality of life for a large number of patients.”
About the Phase 2b Trial
The Phase 2b study included an adaptive trial design and enrolled a total of 180 adult patients
with PDN. Patients in the study applied ARC-4558 0.1% gel or placebo to the affected area three times
a day (3.9 mg clonidine per day) for a 12-week treatment period. Patients were able to continue taking
a stable dose of their existing pain medications. The primary endpoint of the study related to the
change in pain at week 12 compared to baseline measured by the numerical pain rating scale (NPRS).
About ARC-4558
ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride (HCL) for topical administration
to the painful area in order to manage the neuropathic pain associated with painful diabetic
neuropathy (PDN). Topical clonidine, through its agonist effects on alpha2 (a2)-adrenergic receptors,
is believed to reduce pain in PDN via local actions on the nociceptors that innervate the affected skin.
Based on the results of clinical trials to-date, Arcion believes that ARC-4558 has a level of efficacy
comparable to systemic therapies in the target population, but with substantially fewer side effects.
The 0.1% gel formulation avoids the treatment area limitations and undesirable aesthetic and skin
reaction issues associated with analgesic patches. Furthermore, the ARC-4558 gel has been shown to
provide analgesia without numbing or anesthetizing the skin.
Has anyone has success using acupuncture for the treatment of painful peripheral neuropathy? I feel for patients who are already on multiple medications its a useful treatment option to offer before adding in yet another tablet.
Sandra
Yes Sandra I have had some success using acupuncture, with some patients rebooking in specifically for a repeat Tx. Others have found no benefit at all and a small few have freaked out. If they suffer from anxiety I now give acupuncutre a wide berth unless they specifically ask for it.
Hope this helps Shaun
New drugs for neuropathic pain
Size of study group
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