[Paresthesia-dysesthesia ("pins-and-needles") is frequently confused with pruritus, but they are not the same. Paresthesia is a form of neuropathic pain, and can be alleviated with a low dose of gabapentin.
按: 皮膚刺癢和皮膚搔癢不一樣。皮膚刺癢是一種神經痛，可以用低劑量的gabapentin消除症狀，皮膚搔癢一般用anti-histamines比較有效。]
Megan Brooks
February 4, 2011 — The US Food and Drug Administration has approved an extended-release formulation of gabapentin tablets (Gralise) for the treatment of postherpetic neuralgia.
Gralise, which has also received orphan drug designation, was developed by Menlo Park, California–based Depomed, Inc, and is licensed to Abbott Products, Inc, in the United States, Canada, and Mexico. Depomed currently expects Gralise will be available later this year.
"Patients with [postherpetic neuralgia] have long struggled to manage pain following herpes zoster infection. Current therapies require dosing multiple times per day and come with a high incidence of troubling side effects," Gordon Irving, MD, from the University of Washington Medical School in Seattle, noted in a statement from the manufacturer.
"The Gralise formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians' treatment armamentarium," Dr. Irving added.
According to the press release, "Gralise was approved on the basis of two phase 3 trials involving 359 patients treated with the drug and 364 treated with placebo. Safety was evaluated in all 723 patients." Efficacy assessment was based on a second phase 3 trial.
In this latter double-blinded trial, 452 patients were randomly assigned to receive extended-release gabapentin tablets (1800 mg once daily) or placebo. Extended-release gabapentin tablet treatment was associated with a statistically significant reduction in average daily pain score compared with placebo, the company reports.
The most common treatment-emergent adverse events associated with extended-release gabapentin tablets were dizziness (10.9% vs 2.2% for those taking placebo), somnolence (4.5% vs 2.7%, respectively), and headache (4.2% vs 4.1%). Most of these adverse effects were either mild or moderate in intensity, according to the company.
The manufacturer also notes that extended-release gabapentin tablets should be titrated during a 2-week period to an 1800-mg, once-daily dose and taken with the evening meal. They also note that "Gralise tablets are not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration."
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
沒有留言:
張貼留言