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FDA Approves Lyrica CR to Treat Neuropathic Pain
Pfizer news release; 2017 Oct 12
The FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and the management of postherpetic neuralgia (PHN).
Indications: Lyrica CR is indicated for the management of DPN and PHN.
Dosage and administration: Administer once daily after an evening meal:
- DPN pain: Initial dose of 165 mg/day; maximum dose of 330 mg/day within 1 week.
PHN: Initial dose of 165 mg/day; maximum dose of 330 mg/day within 1 week. Maximum dose of 660 mg/day.
Efficacy and safety: Approval is based on results from a randomized trial showing that nearly three-fourths of patients receiving Lyrica CR achieved at least 50% improvement in pain intensity, vs 55% of those taking placebo.
Side effects/risks: The most common adverse reactions are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.
US FDA approves Lyrica CR (pregabalin) extended-release tablets CV. [news release]. New York: Pfizer, Inc. October 12, 2017. https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_lyrica_cr_pregabalin_extended_release_tablets_cv. Accessed October 18, 2017.
Lyrica CR [package insert]. New York: Pfizer, Inc. 2017. http://labeling.pfizer.com/ShowLabeling.aspx?id=9678. Accessed October 18, 2017.