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Recently approved drugs may offer benefits for patients with diabeticperipheral neuropathy.
On December 31, 2004, the Food and Drug Administration (FDA) grantedapproval for the marketing of pregabalin capsules (Lyrica, Pfizer) for themanagement of nerve pain due to diabetic peripheral neuropathy andshingles.
Last September, duloxetine (Cymbalta, Lilly) received FDA approval formanagement of diabetic peripheral neuropathy.
PREGABALIN
Pregabalin works by a newly discovered mechanism of action, blocking areceptor on over-firing nerve cells and reducing the symptoms of nervepain.
The safety and efficacy of pregabalin was established in at least sixdouble-blind, placebo-controlled clinical trials, according to Pfizer.
In one 5-week study of 337 people with diabetic nerve pain, 46% of thosereceiving a 300 mg daily dose and 48% of those receiving a 600 mg daily doseof pregabalin experienced a 50% or greater improvement in pain, compared with18% of those who took placebo.
In a second, 8-week study of 146 people with diabetic peripheralneuropathy, 40% of those treated with 300 mg of pregabalin daily had a 50%improvement in their nerve pain, compared with 15% of those receivingplacebo.
Side effects from drug therapy with pregabalin were few, according toPfizer, and included dizziness, sleepiness, dry mouth, peripheral edema,blurred vision, weight gain, and difficulty with concentration.
Although few details about pregabalin therapy have been published in themedical literature, experts say that it could be useful in clinicalpractice.
Pregabalin is particularly suited for "recalcitrant, difficultpatients who fail other therapy," says Brett Stacey, MD, medicaldirector of the Pain Management Center at Oregon Health and Science Universityin Portland.
DULOXETINE
Previously approved as an antide-pressant drug, duloxetine targetsserotonin and norepinepherine, both believed to play a role in pain perceptionand depression.
The safety and effectiveness of duloxetine were established in tworandomized, controlled studies of 1,074 patients. In these trials, 58% ofpatients treated with duloxetine reported at least a 30% sustained reductionin pain. In comparison, 34% of patients treated with placebo reported thismagnitude of sustained pain reduction.
The most commonly reported side effects were nausea, dry mouth,constipation, and diarrhea. Some patients experienced dizziness and hotflashes.
MARKET READINESS
"We all have patients [with peripheral neuropathy] where nothingseems to work," says neurologist Ann Noelle Poncelet, MD, at theUniversity of California, San Francisco. "There's always an interest infinding agents that can help our patients be more comfortable with a goodside-effect profile."
Anticonvulsants such as gabapentin (Neurontin, Pfizer) and topiramate(Topamax, Ortho-McNeil) are often prescribed for peripheral neuropathy on anoff-label basis. Last December, Ortho parent Johnson & Johnson halteddevelopment of a sustained-release formulation of topiramate when the drugfailed to demonstrate benefit beyond the immediate-release version already onthe market (DOC News, January 2005).
In July 2004, Pfizer received marketing approval by the European Union ofpregabalin for the management of peripheral neuropathy and as an adjuncttherapy for the treatment of partial seizures.
In the U.S., Pfizer sought—and was denied—approval ofpregabalin for the treatment of epilepsy and general anxiety disorder. Companyspokesperson Rebecca Hamm says that Pfizer is reviewing FDA comments andrequirements for pursuing other indications for pregabalin.
Having cleared the FDA hurdle, pregabalin will be available "in thenear future," says Hamm. As a controlled substance, the drug mustundergo review by the Drug Enforcement Agency prior to marketing. 
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| DOC News | Diabetes | Diabetes Care | Clinical Diabetes | Diabetes Spectrum |
