http://biz.yahoo.com/prnews/060918/nym193.html?.v=57

Press Release Source: Pfizer Inc


Pfizer's Lyrica(R) Approved in Europe for Difficult-to-Treat Nerve Pain
Monday September 18, 2:24 pm ET
- Lyrica's neuropathic pain indication broadened to include central nerve pain; Central nerve pain is associated with conditions such as spinal cord injury, stroke, and multiple sclerosis
- A robust and unprecedented clinical program involving more than 10,000 patients supports Lyrica's efficacy and safety in treating a broad range of neurological disorders
- Medical Expert: 'Physicians will be in a better position to manage a whole host of difficult-to-treat nerve pains for many of their patients.'


NEW YORK, Sept. 18 /PRNewswire-FirstCall/ -- Pfizer Inc said today that the European Commission approved Lyrica® (pregabalin capsules) to treat central neuropathic (nerve) pain. This new approval broadens the current range of neuropathic pain that Lyrica is approved to treat in Europe to include nerve pain associated with conditions such as spinal cord injury, stroke, and multiple sclerosis. Central neuropathic pain can be an especially difficult-to-treat condition, often requiring the use of strong narcotics. Lyrica's approval in central neuropathic pain provides further evidence of its robust efficacy in even the most hard to treat neuropathic pain conditions. Now, Lyrica is the only medication approved in the EU to treat both peripheral and central neuropathic pain, which affects up to 7.7 million people in Europe.

Developed by Pfizer, Lyrica is believed to work by calming hyper-excited neurons which may be an underlying cause for various types of nerve pain.

"This approval underscores Pfizer's commitment to providing much needed therapies for complex and poorly managed pain conditions," said Dr. Joseph Feczko, Pfizer's Chief Medical Officer. "A robust and unprecedented clinical program involving more than 10,000 patients supports the efficacy and safety of Lyrica across a range of neurological disorders."

Neuropathic pain may be the result of a primary lesion or dysfunction of either the peripheral or central nervous system. Characterized by a burning, tingling and/or shock-like sensations, neuropathic pain is a type of chronic pain that is often misdiagnosed, under-treated, and a significant burden to patients, their families and society. Neuropathic pain disrupts a patients' ability to go about their daily activities. For example, patients often miss work, have difficulty concentrating and find that wearing clothing can be painful. Neuropathic pain is also associated with impairments in sleep as well as increased anxiety and depression.

Lyrica's central neuropathic pain approval was based on the largest controlled study conducted to date in central nerve pain. In a clinical trial involving 137 patients with chronic central neuropathic pain following spinal cord injury, patients taking Lyrica experienced a significant reduction in the average intensity of their pain compared to those taking placebo. Pain reduction with Lyrica was demonstrated as early as the first week of treatment and was sustained throughout the study. More than 40 percent of patients had greater than a 30 percent reduction in pain as compared to 16 percent of patients on placebo. Patients taking Lyrica also reported a significant reduction in pain-related sleep interference compared to patients taking placebo.

"This is a new day for some patients who live in excruciating pain," said Dr. Philip Siddall, Lyrica clinical trial investigator and Clinical Associate Professor at the University of Sydney Pain Management Research Institute, Sydney, Australia. "In a controlled clinical trial, Lyrica relieved excruciating nerve damage pain related to spinal cord injury for which there are currently limited treatment options. Physicians will be in a better position to manage a whole host of difficult-to-treat nerve pains for many of their patients."

Painful nerve disorders can pose a significant economic burden as patients seek relief from their pain. Since patients frequently have co-morbid conditions, such as depression and anxiety, patients are more likely to use healthcare services. Total average healthcare charges are estimated to be three-fold higher among people with painful nerve disorders, compared with the general population.

The most common adverse events reported by patients were somnolence, dizziness, edema and asthenia (fatigue). Most adverse events tended to be mild to moderate in intensity and generally dose related. Despite no known pharmacokinetic drug-drug interactions, certain adverse events which may result in impairment of cognitive and gross motor function may appear more commonly when Lyrica is co-administered with oxycodone, lorazepam or ethanol.

In 2004, Lyrica was approved for use in adults for the treatment of various peripheral neuropathic pain indications, including diabetic and post herpetic neuropathic pain, and adjunctive therapy for partial epilepsy in more than 60 countries outside of the United States. In 2006, Lyrica was also approved for the treatment of generalized anxiety disorder in Europe.

In the United States, Lyrica® (pregabalin) capsules C-V are approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, as well as for the adjunctive treatment of partial onset seizures in adults.




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Source: Pfizer Inc

I know a few people who have switched from Neurontin to Lyrica and like it much better. It seems to be better tollerated by some.

I don't have pain that I can't handle without meds, so I've never tried it, but Good luck to those who do. Nerve pain is the worst.

Okay!!! Sign me up!!! Does anyone here take Lyrica? I'm going to ask my neuro for some to try since both central nerve pain and neuropathy are one of my biggest symptoms. Has anyone taken it along with LDN or know how the two react together?

I'm always hopeful when hearing of something new for this horrible pain. Up until now, nothing really works. Keeping all my fingers, and toes, crossed -- well sort of!

Judy

I like Lyrica better than
Neurontin.
I take 50 mg before bed.
Helps with nighttime pain.

I've been taking Lyrica (a lot of it) for several months- I'm up to 450 mg/day. It does seem to leave me less dopey than Neurontin.

Before Lyrica, I was on Neurontin for years, with an escalating dose and attendant side effects, but decreasing relief. Initially, Lyrica made things a lot better, but I'm on the cusp of switching again, this time to Cymbalta. The burning sensation in my legs, feet, and, uh, crotch, has become intolerable.

I've been on Cymbalta in the past, and it worked well for the pain, but it really aggravated my bladder issues. This time around, I've contacted my urologist to see if there's something he can do for me to make Cymbalta work this time around.

Doug

Sorry to hijack a bit, but I have been concidering changing from Paxil to Cymbalta for my anxiety and depression, and am wondering about your bladder problems with it, Doug. Were the serious?

I have less bladder problems, since starting LDN and I'd hate to mess that up, with Cymbalta. It helping with burning sensations is a great plus, IMO.

I know that you have to watch your liver enzymes while on Cymbalta, but I intend to take milk thistle to help with that possible problem.

Thanks.

Sally,
I was only on Cymbalta for 9 days. During that time I had to start cathing again as I lost the sensation to empty my bladder. I do not suffer from incontinence but retention.

Wannabe,
Thanks for this article. I had someone call me asking for information on this drug today. They have been on it for about 6 months and it seemed to work initially but is not seeming to be effective now for them.

I was on Cymbalta - 30 mg in the morning for 30 days. I loved it. It did not do anything as far as bladder is concerned. Everything was good except that I could not sleep. I really wish I could have taken this drug. I even tried 20mg. It still helped with the pain and spasticity, but I still could not sleep.

I would have to recommend that anyone with burning pain or spasticity, at least give it a try. It is expensive, so maybe just ask for a couple of weeks or long enough to see if you can take it, and if so then get more. I am very drug sensitive, so it is not surprising that I could not sleep. Also, I have sleep problems anyway.

Virginia

I noticed a lessening of pain within the first couple of days. I just could not sleep while on it even with Ambien.

As I was scrolling down the list of forums to get here, a post in Chronic Pain caught my eye. It was on side effects of Lyrica.

So I thought I'd copy a link here in case anyone wants to read about people's experience there with it.

http://forums.braintalk2.org/showthread.php?t=1260