Pfizer’s novel NGF pain drug is potential game changer
 
 Phase II clinical trials of tanezumab in osteoarthritis, chronic low back pain and interstitial cystitis have demonstrated the drug’s analgesic efficacy across these three chronic pain settings. Despite safety concerns and a high price point, it expects tanezumab to delight in a significant first-in-class advantage in a potentially lucrative novel area of pain therapy. ( http://www.bharatbook.com/detail.asp?id=130154&rt=Stakeholder-Insight-Osteoarthritis-Drug-development-lags-behind-rising-osteoarthritis-population.html )
 
 Pfizer has announced positive results from three Phase II trials in pain at the American Academy of Pain Medicine’s 26th Annual Meeting. The randomized, double-blind, placebo-controlled six-week trials in patients with chronic low back pain (CLBP) and interstitial cystitis receiving a single intravenous infusion of tanezumab (200mcg/kg) met their primary endpoints of significantly superior pain relief over placebo. The CLBP study also included a third treatment group receiving naproxen twice daily, and tanezumab showed a greater analgesic effect than this competitor. In the 16-week osteoarthritis trial, patients were randomized to received tanezumab (10mcg/kg, 25mcg/kg, 50mcg/kg, 100mcg/kg or 200mcg/kg) or placebo. All doses of the drug achieved a reduction in pain while at the same time demonstrating a favorable safety profile.
 
 It estimates that 140 million people suffer from chronic pain across the seven major markets (the US, Japan, France, Germany, Italy, Spain and the UK). Chronic pain treatments include narcotic analgesics and non-steroidal anti-inflammatory drugs (NSAIDs); but, these therapies suffer from high abuse potential and limited efficacy. Given that pain will become more prevalent in the future due to the aging population, the chronic pain market continues to represent an attractive commercial opportunity for pharmaceutical developers.
 
 Tanezumab is a humanized monoclonal antibody (mAb) against nerve growth factor (NGF) and is in position to become Pfizer’s first pain medication since its neuropathic pain treatment Lyrica (pregabalin) was approved in 2005. With strong efficacy demonstrated in different pain settings, the drug is expected to be the first major novel therapy in the management of pain for a number of years. But, while tanezumab offers excellent evidence as a ‘proof of concept’ that interfering with the NGF pathway provides an analgesic effect, strong competition exists in the pipeline: Johnson & Johnson’s JNJ-42160443; Sanofi-Aventis’ and Regeneron’s Phase II drug REGN475; and Abbott’s PG110, which entered Phase I clinical trials in mid-2009.
 
 Although the NGF class uses a novel mechanism for the treatment of pain, it believes that drug safety profiles may limit the patient population. Adverse events documented thus far include an abnormal peripheral sensation (tingling and numbness) and muscle aches. Moreover, given that NGF is involved in the development of the nervous system, reproductive toxicology issues will prevent its use in women of childbearing age. Another limiting factor could be cost: It expects that these therapies will be priced similarly to the biologics available to treat rheumatoid arthritis, and as such will be far more expensive than existing pain treatments. This will lead to insurance companies effectively forcing clinicians to try current therapies first, with NGF drugs held back as last-line alternatives.
 
 With the investment made by major pharmaceutical companies, the success of tanezumab (and that of the whole NGF class) will be dependent on the characterized risk-benefit profile. Phase II data suggest efficacy in a number of pain conditions. But, at present no patient has received at least a year’s treatment with tanezumab, so its long-term safety profile remains unknown. its recommends that NGF drug developers also pursue indications in acute pain, in case the chronic use of these therapies proves intolerable. With the pain market totaling .4 billion in 2008 across the seven major markets and the lack of efficacious pain treatments, NGF drugs could capture a considerable proportion of this market. Following analysis of Phase III trials that are due to end in 2011, it anticipates the launch of tanezumab in 2012 as the first biologic for the management of pain.
 
 Related research
 
 • Stakeholder Opinions: Back Pain – Gain competitive edge by targeting subpopulations
 http://www.bharatbook.com/detail.asp?id=98237&rt=Stakeholder-Opinions-Back-Pain-Gain-competitive-edge-by-targeting-subpopulations.html
 
 • Stakeholder Insight: Osteoarthritis – Drug development lags behind rising osteoarthritis population priced
 http://www.bharatbook.com/detail.asp?id=130154&rt=Stakeholder-Insight-Osteoarthritis-Drug-development-lags-behind-rising-osteoarthritis-population.html
 
 • Pfizer Inc.: PharmaVitae Profile
 http://www.bharatbook.com/detail.asp?id=70276&rt=Pfizer-Inc-PharmaVitae-Profile.html
 
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I have been in pain management for 4 months now and have not had one problem until this month, and go figure, this is the month that I have to see my dr before he will give me anymore refills. I had kidney stones and my oxycontin and percocets weren’t touching the pain, so I went to the ER and got injected dilaudid for the pain. Will this show up differently than the pain meds i’ve already been prescribed by my Dr?

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Breakthrough medical technology really “puts your head on straight” and adjusts the bones of your skull FROM THE INSIDE OUT without expensive drugs and perilous surgical procedures.

Your neck and back are sore because they’re compensating all day long to keep your 10 pound head balanced. Neurocranial Restructuring (NCR) is the only protocol that quickly, safely and gently rebalances both the bones of the skull, and how your head sits on top of your spine to relieve your chronic pain once and for all.

Physiotherapy, chiropractic, osteopathy, and even orthopedic surgery pale in comparison to the results of this natural treatment. Massage, exercise and stretching are fantastic, but they don’t address the cause.

Common benefits of NCR include:

- Relief from chronic shoulder, neck and back pain (upper, lower, left, right)
- Scoliosis, Lordosis (swayback) and Kyphosis (hunchback) lessen dramatically
- Long lasting relief from head injuries and post concussion syndrome symptoms

- Improved attractiveness as your ears, eyes and entire face become more symmetrical, cheek bones rise, narrow and sharp features soften, & wrinkles usually diminish
- Bald men get a sexier head as unattractive ridges, peaks, and dents lessen
- Mental clarity improves as your brain gains “more room to reckon”

- Snoring, chronic sinus and ear problems routinely improve
- TMJ symptoms diminish as the jaw starts tracking properly
- List of other conditions NCR benefits below

You’ve been to the hospital, clinic and doctors office enough. 99.9% of M.D.’s and even chiropractors are not trained in this remedy. You need a specialist.

Well-known celebrities and everyday people spend a fortune working with plastic and cosmetic surgeons. Bald men commonly were hats to hide their heads. Instead of a facelift or a nose job, try NCR.

I’m a huge supporter of Kevin Trudeau, and look forward to connecting with him. I too lost my health early and battled with “incurable” health problems. Natural Cures are the answer — you just might know this if you haven’t exhausted conventional medicine yet. If you know Kevin or are a subscriber to his naturalcures.com website, tell him about NCR. He’s got to try this. He’ll absolutely Like it!

NCR is currently available in California, Florida, Texas, Washington and even in Canada. You won’t hear about it in the news, your favorite TV show, radio program, or well loved magazine and certainly not from CNN, NBC, ABC, CBS, FOX, the AMA, FDA or WHO. Even The Health Network, Discovery Channel, Dr. Andrew Weil, Oprah and Dr. Phil probably don’t know about NCR yet. I hope they see this free video and do a tale on this outstanding treatment that has done so much for me.

I’m a huge hockey fan. I like playing and watching the game. I reckon it’s tragic how concussions end the careers of so many NHL players. One of my goals is to raise the awareness for NCR as the solution for those who suffer from concussion symptoms.

These days the game is so quick that wingers, centers and defensemen are getting smoked with huge hits. I’d like this message to get to high profile guys like Eric Lindros, Jeremy Roenick, Sydney Crosby, Joe Thornton, Eric Stall, and the players on my favorite team, the Vancouver Canucks (Dave Nonis, Steve Tambellini, Alain Vigneault…are you reading this?)

For instance, winger Jason King is a fantastic skater with an unfortunate history of concussions. I’d like if ESPN or CBC’s Ron McLean mentioned NCR or Don Cherry did in his next Rock ‘Em Sock ‘Em dvd.

Head injury from football and boxing injuries would benefit from NCR. The blows those guys take to the cranium is incredible. CTE (chronic tramatic encephalopathy) and MTBI (mild traumatic brain injury) were recently mentioned in Well loved Science as huge issues and the use of X-rays in diagnosis and a Concussion Summit in Chicago.

Other conditions for NCR: migraine headaches, arthritis, whiplash, ostitis media, bursitis, rheumatism, learning disabilities, poor concentration, Sciatica, acute sinusitis, Sleep Apnea, teeth grinding, Tinnitus, TMD

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