Free Republic
Browse · Search
News/Activism
Topics · Post Article

Skip to comments.

LYRICA (PREGABALIN) - NEW GABAPENTINOID WITH WIDE CLINICAL APPLICATION
manufacturer's statement ^ | Pfizer

Posted on 07/31/2006 9:04:20 PM PDT by MainFrame65

Developed by Pfizer, pregabalin, marketed under the brand name Lyrica, is a 3-substituted analogue of gamma-amino butyric acid (GABA) and a compound related to Pfizer's hugely successful antiepileptic drug gabapentin (Neurontin).

In July 2004, Pfizer secured Europe-wide approval for Lyrica (pregabalin) for use in the management of peripheral neuropathic pain as well as an adjunctive therapy in the treatment of partial epileptic seizures. Subsequently in December 2004 the company gained FDA approval for use of Lyrica (pregabalin) in neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia; making it the first FDA-approved treatment for both of these neuropathic pain states. Lyrica (pregabalin) is also being reviewed by the FDA as an adjunctive treatment for partial epileptic seizures in adults. A SUCCESSOR TO GABAPENTIN

First marketed in 1983, gabapentin (Neurontin) has been one of Pfizer's top performing drugs. Lyrica (pregabalin) is seen as an important successor now that gabapentin is facing the threat of generic competition.

Both drugs share a similar mechanism of action: binding to calcium channels and modulating calcium influx as well as influencing GABergic neurotransmission. This mode of action translates into anti-epileptic, analgesic and anxiolytic effects. Because it is more potent than gabapentin, Lyrica (pregabalin) achieves efficacy at lower doses. This increases its therapeutic index with respect to gabapentin and should lead to fewer dose-related side effects. Clinical studies with Lyrica (pregabalin) have been carried out on over 10,000 patients worldwide. CLINICAL STUDIES WITH LYRICA (PREGABALIN) IN EPILEPSY

Gabapentin is approved worldwide for adjunctive treatment of patients with partial epilepsy. Because it is not metabolised (and so does not alter the pharmacokinetics of co-administrated drugs) it is a good candidate for use in combination with other antiepileptic medications. Clinical studies with oral Lyrica (pregabalin) suggest it is at least as effective as gabapentin as adjunctive therapy in patients refractory to one or more conventional antiepileptic drugs. In large-scale, placebo-controlled studies of 12 weeks' duration, add-on therapy with oral Lyrica (pregabalin) reduced seizure frequency by up to 75%. In these studies doses of Lyrica (pregabalin) ranged from 150mg to 600mg daily. CLINICAL STUDIES WITH LYRICA (PREGABALIN) IN NEUROPATHIC PAIN AND ANXIETY DISORDER

Neuropathic pain is chronic pain that arises from damage to sensory nerves. It can include:

* Pain arising from trapped or compressed nerves * Drug-induced nerve damage * Diabetic neuropathy * Post-herpetic pain * Phantom limb syndrome following limb amputation * Peripheral neuropathy * Fibromyalgia

Neuropathic pain generally does not respond to treatment with opioid or non-steroidal anti-inflammatory drugs (NSAIDs). At high doses gabapentin has proven effective against neuropathic pain induced by diabetic neuropathy and postherpetic neuralgia. Data from clinical studies show that Lyrica (pregabalin) shares this analgesic effectiveness. Efficacy has been demonstrated in a number of clinical studies, including those in patients with diabetic neuropathy and fibromyalgia. Treatment of neuropathic pain is seen as the drug's leading indication.

A double-blind, placebo-controlled monotherapy study in 529 patients with fibromyalgia, for example, showed that eight weeks' treatment with Lyrica (pregabalin) 150mg to 450mg per day produced significantly greater reductions in pain compared with placebo as well as improving sleep quality and fatigue. Pain, sleep disturbances and fatigue are core symptoms of fibromyalgia, which has proved an extremely difficult condition to treat.

Data from a series of phase II and III placebo-controlled clinical studies in over 1,200 patients with generalised anxiety disorder suggest that Lyrica (pregabalin) will be effective for this disabling disorder. In comparison with venlafaxine, pregabalin provided more rapid relief of psychic and somatic symptoms. In comparison with alprazolam (a benzodiazepine), Lyrica (pregabalin) appeared equally effective in reducing somatic symptoms. Overall, these findings show that Lyrica (pregabalin) combines the benefits of both antidepressants and benzodiazepines. It appears at least as rapid as benzodiazepines against somatic symptoms, while providing more rapid control of psychic symptoms than antidepressants.

MARKETING COMMENTARY

Once generic manufacture of gabapentin is approved, sales of Pfizer's Neurontin are likely to fall dramatically. Encouraging physicians to switch patients from Neurontin to Lyrica (pregabalin), if approved, will be an important strategy in minimising the impact of generic competition. Lyrica (pregabalin) is as effective as Neurontin, but at lower doses, which translates to fewer side effects. Thus, it is well placed to capture Neurontin's market share. Through the successful launch of follow-on products, Pfizer has maintained leadership in other CNS areas, such as the market for antidepressants.


TOPICS: Miscellaneous
KEYWORDS: epilepsy; health; lyrica; medicine; neuropathy; pregabalin
I am posting this article because this drug actually seems to be effective at relieving the near-complete loss of sensation in my feet due to Diabetic neuropathy. I had been taking Neurontin (gabapentin) for two years, while my feet lost feeling and did not recover at all, except for a minor blip - just a few days - when I started taking Cardura for hypertension.

In one week on Lyrica, I am actually recovering some sensation in both feet. So far, they mostly just tingle and feel hot or cold, but I am beginning to have a better sense of their position and location.

1 posted on 07/31/2006 9:04:22 PM PDT by MainFrame65
[ Post Reply | Private Reply | View Replies]

To: MainFrame65

glad to hear it....hope you continue to improve....


2 posted on 07/31/2006 9:10:08 PM PDT by cherry (.)
[ Post Reply | Private Reply | To 1 | View Replies]

To: MainFrame65

Thanks for posting.


3 posted on 07/31/2006 9:10:59 PM PDT by EternalHope (Boycott everything French forever. Including their vassal nations.)
[ Post Reply | Private Reply | To 1 | View Replies]

To: MainFrame65
Didn't one of the TV newsmagazines do an expose on Neurontin being marketed off-market, for symptoms it wasn't supposed to be good for?

Anyway, good luck w/your treatment. Let's hope this new stuff works.

4 posted on 07/31/2006 9:16:22 PM PDT by japaneseghost (()
[ Post Reply | Private Reply | To 1 | View Replies]

To: MainFrame65
LYRICA (PREGABALIN) - NEW GABAPENTINOID WITH WIDE CLINICAL APPLICATION

You had me at pregabalin. Seriously though, good luck w/your treatment.

5 posted on 07/31/2006 9:26:21 PM PDT by highimpact
[ Post Reply | Private Reply | To 1 | View Replies]

To: MainFrame65

Lyrica? Hope it works as anticipated. As a tenor, I am tempted to take it just because of the name.

Cousin Vinnie


6 posted on 07/31/2006 9:42:01 PM PDT by csn vinnie
[ Post Reply | Private Reply | To 1 | View Replies]

To: MainFrame65

Wish this was available when I contracted shingles (at the ripe "old" age of 32... stress at work was a killer and my imune system failed... I hate when that happens.


7 posted on 07/31/2006 9:54:24 PM PDT by Trajan88 (www.bullittclub.com)
[ Post Reply | Private Reply | To 1 | View Replies]

To: MainFrame65

Lyrica made me so addled and made it very difficult to think that I had to stop taking it.

I am glad that it works for you, however.


8 posted on 07/31/2006 10:16:23 PM PDT by arjay (I would rather be right than consistent.)
[ Post Reply | Private Reply | To 1 | View Replies]

To: MainFrame65

I have found it to be a very effective drug for many of my patients.


9 posted on 07/31/2006 11:24:40 PM PDT by yevgenie (A RINO is just a JACKASS with a RAT'S *** (behind/tail) on its face.)
[ Post Reply | Private Reply | To 1 | View Replies]

To: highimpact

LYRICA (PREGABALIN) - NEW GABAPENTINOID WITH WIDE CLINICAL APPLICATION

You had me at pregabalin. Seriously though, good luck w/your treatment.

LOL - me too. I may be kolege edukatid but the title is way over my head.


10 posted on 07/31/2006 11:29:12 PM PDT by peggybac (Tolerance is the virtue of believing in nothing)
[ Post Reply | Private Reply | To 5 | View Replies]

To: japaneseghost

pfizer paid $400m fine for detailing physicians on Neurontin on pain (several years ago), as it did not have FDA approved indication for pain at the time (it was originally developed as anti-seizure med and did have FDA approval ). Later, Neurontin did get the FDA indication for neuropathic pain after proving itself in clinical trials. It is actually quite effective in many cases ( I think it's in top 10 of all prescriptions written). As patent was expiring on Neurontin, Pfizer developed Lyrica, but according to this testimonial and others it is more than just a marketing ploy to extend the profitability (e.g. Nexium for Prilosec, Paxil CR for Paxil, etc., etc.) Too bad TV networks don't have to pay multimillion dollars fines for some of the false info they put out; it might force them to clean up their acts too.


11 posted on 08/01/2006 4:06:07 AM PDT by gusopol3
[ Post Reply | Private Reply | To 4 | View Replies]

To: MainFrame65
Glad to hear it. Caffeine for me


12 posted on 08/01/2006 4:16:50 AM PDT by Liberty Valance (Keep a simple manner for a happy life)
[ Post Reply | Private Reply | To 1 | View Replies]

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.

Free Republic
Browse · Search
News/Activism
Topics · Post Article

FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson