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Background for NeurogesX and Neuropathic Pain

Background for NeurogesX and Neuropathic Pain

This is a guest series from Drew Waight a graduate student at NYU. Leave him a comment if you like his analysis and maybe he’ll send another one in. I should be back in August when I’ve finally made my escape from the lab and no longer have two jobs. Until then, you can catch my analysis of big biotech (and pharma too) at The Fool.

NeurogesX

Website: http://neurogesx.com
IPO date: 05/02/2007
Market Cap : $101 million
Shares Outstanding : 12.49mln
Float: 10.23mln

Neurogesx (NGSX) is a biopharmaceutical company developing and commercializing novel pain management therapies. More specifically, their main niche involves the area of neuropathic pain. Let’s take a closer look at the details and prevalence of this affliction, focusing specifically on the treatments NGSX has in the pipeline.

Therapeutic Areas

Neuropathic pain is caused by diseases or trauma that produce lesions in the central (e.g., stroke, spinal cord injury, multiple sclerosis [MS]) or peripheral (e.g., surgery, diabetic neuropathy, herpes zoster) nervous system. Peripheral neuropathy (neural damage in the extremities) is the most common which mainly affects the feet and legs. The most recent studies suggest that more than two million adults in the U.S. suffer from neuropathic pain.

Post-herpetic neuralgia (PHN) constitutes about 200k cases per year. In this disorder, factors such as age, illness, stress or medications can reactivate an otherwise dormant chickenpox virus (varicella-zoster), causing shingles (herpes zoster). The virus travels along nerve fibers, causing pain. When the virus reaches the skin, it produces a rash and blisters. These cases of shingles usually heal within a month, however in roughly 20% of cases the patient continues to feel pain long after the rash and blisters heal. This pain is known as postherpetic neuralgia.

Painful HIV-Associated Neuropathy (HIV-DSP) is among the most common of the pain syndromes afflicting HIV-infected individuals. It is thought that nearly one third of people with HIV/AIDS experience some peripheral nerve damage caused either by the virus itself, by certain drugs used in the treatment of HIV/AIDS, or by secondary complications from the disease.

Almost 16 million Americans had diabetes in 2005. Of these “complications” 60-70% of diabetics have mild to severe forms of nervous system damage. While the first sign of diabetic neuropathy is usually numbness, Painful diabetic neuropathy (PDN) often manifests in the form of a burning or other painful sensation most commonly in the feet and lower extremities.

Treatment

Over the counter analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs have not been shown to be highly effective in the treatment of neuropathic pain. The treatments that are available for the above conditions are largely similar and the common underlying mechanism of action is reduction of neuronal hyperexcitability. Topically, Capsaicin creams derived from natural chili pepper plants have long been known to provide temporary relief. Similarly, Lidocaine (topical local anesthetic) patches are also effective for pain management. Both of these treatments last between 4 and 12 hours however, and require multiple applications per day. Both tricyclic antidepressants (TCA) and serotonin reuptake (SSRI) inhibitors are used to treat neuropathic pain, it should be noted that while generally SSRIs are safer for use in the general population, they have less consistent effects than the TCA class. Finally, anticonvulsants such as phenytoin (Dilantin), carbamazepine (Tegretol) and gabapentin (Neurontin) are frequently prescribed for neuropathic pain and have been shown to be effective in double-blind placebo controlled studies. Some caveats to the anticonvulsant class of medications include a relatively notorious list of adverse side-effects and unpredictable response to the treatment.

In summary, the therapeutic focus on neuropathic pain does in fact constitute an area of unmet medical needs. The major diseases which cause the neuropathies above (herpes zoster, HIV and especially diabetes) are ubiquitous illnesses which are not predicted to be decreasing in the future. Furthermore, treatment for these neuropathies (with the exception of topical agents), largely revolve around the secondary analgesic effects of neurological pharmacologics which in some cases may be beneficial if the patient is already depressed. Nevertheless, it seems there is still plenty of room in the market for a more subtle topical treatment option such as Neurogesx has developed.

Next time: Neurogesx flagship product, the trans-capsaicin patch. I’ll also cover their clinical trial status and scientific patents protecting their quasi-novel approach to management of neuropathic pain disorders.

47 Responses to “Background for NeurogesX and Neuropathic Pain”

  1. […] Last time I covered the therapeutic market area of neuropathic pain, which is NeurogesX’s major area of focus. This time I’ll be doing the due diligence on their first product candidate NGX-4010, and it’s safe to say that the entire company rests with the fate of this therapeutic. NGX-4010 is a non-narcotic analgesic formulated in a topical (transdermal) patch containing an 8% concentration of synthetic capsaicin. Capsaicin is released from the patch and absorbed into the skin without significant absorption into the bloodstream. […]

  2. Do you guys have any idea how big these potential markets could be for NGSX in terms of sales?

  3. I am a pain patient having great difficulty getting adequate help. I live in Huntington Beach, Ca. I had multiple neruoma sugeries in my feet which gave minor relief, but caused fibromyalgia and some kind of tingling pain in my legs. I also have disc disease, overuse in my arms and hands and carpal tunnel. In spite of this, I lived in this pain for 20 years, raising a family and working, doing the best I could and being a member of life. I was not a person to give up.
    One year ago, I decided to try prolotherapy shots in my feet to see if I could reduce the pain. Of all my health decisions this was the worst. The injections caused great swelling and pain, and when the swelling went down, the pain stayed in my feet and move up my legs to my spine in such debilitating degree that I cannot stand for more than five minutes. I have a burning, stabbing, knifing pain that gets to level 8 or 9 pain if I try to walk. I feel as if someone is cutting the nerves in my spine legs and feet and electrocuting me at the same time. I am no longer part of life, but am mostly bed bound and in a wheelchair most of the time.
    it is neuropathic pain with a central pain part to it. Is there a chance that i can get this product and live again.
    Stephanie Anderson

  4. have been diagnosed with neuropathy and have an appointment with a neurologist on sept 22.my general dr. has perscibed me neurontin and now have switched me to lyrica.but i still have active blisters on my toes and now runnin down the left side of my neck.is there anything to do?

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