Pharmacokinetics, Efficacy, and Safety

Painful Diabetic Peripheral Neuropathy (Painful DPN) and Postherpetic Neuralgia (PHN) Clinical Information
*Support for the efficacy of LYRICA CR for the management of PHN and painful DPN was based on the efficacy of LYRICA for these indications along with an adequate and well-controlled study in adults with PHN.
Pharmacokinetics
When taken after an evening meal
LYRICA CR has the same bioavailability as the corresponding LYRICA dose1
Pharmacokinetic data do not predict clinical efficacy or safety.
• LYRICA CR administered once daily following an evening meal has equivalent AUC and lower Cmax relative to a comparative dose of LYRICA administered twice daily without food. Time to reach maximum concentration (Tmax) following a 330-mg dose of LYRICA CR is approximately 10 hours (5 to 12 hours), compared to <1 hour for LYRICA.1
• Three additional studies comparing other LYRICA and LYRICA CR doses, and with the same food restrictions, also demonstrated similar bioavailability.1
LYRICA CR tablets utilize a gastric retention formulation platform, which more gradually releases pregabalin into the small intestine and proximal colon2
*2x165 mg once-daily CR with food not shown.
AUC=area under the plasma concentration-time curve; Cmax=peak plasma concentrations.
Study descriptions
Efficacy
In a 5-month pivotal PHN trial, LYRICA CR significantly reduced pain intensity
LYRICA CR treatment demonstrated statistically significant improvement in the endpoint change in mean score from baseline compared to placebo
• 74% of patients on LYRICA CR experienced at least 50% improvement in pain intensity vs 55% on placebo
Support for efficacy of LYRICA CR for the management of PHN and painful DPN was based on the efficacy of LYRICA for these indications along with an adequate and well-controlled study in adults with PHN
Based on the cumulative results of a 19-week, randomized withdrawal trial that compared daily doses of LYRICA CR 82.5 mg, 165 mg, 247.5 mg, 330 mg, 495 mg, or 660 mg with placebo. Those enrolled were required to have pain present for more than 3 months after healing of the herpes zoster skin rash and a baseline pain score of greater than or equal to 4 on the numeric rating scale (NRS). Pain was assessed over a 1-week recall period. The baseline mean pain scores were 6.83 for LYRICA CR-treated patients vs 6.85 for placebo-treated patients.
Study descriptions
Safety
Adverse reactions in a controlled PHN trial2
Reactions in ≥4% of all LYRICA CR-treated patients and occurring at least twice the rate of placebo
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice
References: 1. Chew ML, Alvey CW, Plotka A, et al. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014;34(9):627-637. 2. Data on file. Pfizer Inc, New York, NY.
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