FDA approves Lyrica for the treatment of two common forms of neuropathic pain

[Guest guest]

(Note: While this mentions diabetic neuropathic pain, this is how

Neurontin/Gabapentin found its way to the CMT community ~ Gretchen)

FDA approves Lyrica for the treatment of two common forms of neuropathic pain

http://www.medicalnewstoday.com/medicalnews.php?newsid=18697

08 Jan 2005

Pfizer Inc said today that it has received approval from the U.S. Food and Drug

Administration (FDA) to market LyricaTM (pregabalin capsules) for the management

of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and

postherpetic neuralgia (PHN). Lyrica is the first FDA-approved treatment for

both of these neuropathic pain states, which are distinctly different from

arthritis or musculoskeletal pain.

Developed by Pfizer, Lyrica has a newly defined mechanism of action. Lyrica will

be available to physicians and patients in the near future.

" Lyrica is an important new therapy for millions of people suffering from the

two most common neuropathic pain conditions as it provides rapid and sustained

pain relief, " said Dr. ph Feczko, president of Worldwide Development at

Pfizer. " Lyrica also represents a major achievement in Pfizer's research program

and confirms our leadership in bringing life-changing medicines to patients. "

Neuropathic pain, one of the most debilitating forms of pain, is caused by nerve

damage that can result from underlying conditions, such as diabetes or shingles.

Nearly half of the 18 million Americans with diabetes will develop some form of

diabetic neuropathy over the course of their disease and about one in six

diabetes patients will experience painful diabetic neuropathy. The pain of DPN

is often described as burning, tingling, sharp, stabbing, or pins and needles in

the feet, legs, hands or arms.

PHN is a complication of shingles, a painful outbreak of rash or blisters on the

skin caused by a reactivation of the same virus that causes chicken pox. Each

year, about 150,000 Americans develop PHN, which is often characterized as

constant stabbing, burning, or electric shock-like sensation.

The efficacy of Lyrica was established in six double-blind, placebo-controlled

trials, three involving patients with DPN and three involving patients with PHN.

Lyrica provided rapid and clinically meaningful pain reduction in a significant

portion of patients, with pain relief beginning as early as the first week of

treatment in some patients. Pain relief was sustained in studies of up to

12-weeks duration.

The safety of Lyrica was established in over 9,000 patients. In all clinical

trials, adverse events were mild to moderate. The most common side effects

associated with Lyrica compared with placebo included dizziness, somnolence, dry

mouth, peripheral edema, blurred vision, weight gain and difficulty with

concentration/attention. The discontinuation rate due to side effects was low.

Lyrica is expected to be classified as a controlled substance in a category with

lower potential for misuse or abuse relative to controlled substances in other

categories.

Lyrica is currently under review by the FDA for the adjunctive treatment of

partial seizures in adults. In July, Pfizer received European Commission

approval to market Lyrica in European Union member states for the treatment of

peripheral neuropathic pain and as adjunctive therapy for partial seizures.