Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Lyrica CR Extended-Release Tablets CV

Pfizer news release; 2017 Oct 12

Pfizer Inc. has announced that the US Food and Drug Administration (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 (pDPN) and the management of postherpetic neuralgia (PHN).

Dosage/administration: Lyrica CR should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. The initial dose for DPN is 165 mg/day; the maximum dose is 330 mg/day within 1 week.  For PHN, the initial dose is 165 mg/day; the maximum dose is 330 mg/day within 1 week, with a maximum dose of 660 mg/day.

Adverse reactions: The most common adverse reactions reported with Lyrica CR were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

Citation:

US FDA approves LYRICA CR (pregabalin) extended-release tablets CV. [news release]. New York, NY: Pfizer Inc. October 12, 2017. http://press.pfizer.com/press-release/us-fda-approves-lyrica-cr-pregabalin-extended-release-tablets-cv. Accessed October 30, 2017.

This Week's Must Reads

Fatigue Index for MS Is Easy to Administer , Int J MS Care; 2017 Sep/Oct; Aldughmi, et al

Ocrelizumab More Cost-Effective Than Interferon, J Med Econ; 2017 Oct; Yang, Duchesneau, et al

Motor, Cognitive Functions Interrelated in MS, J Neural Transm (Vienna); ePub 2017 Oct 25; Hsieh, et al

Self-Compassion May Provide Coping Strategy, Disabil Health J; ePub 2017 Oct 23; Nery-Hurwit, et al

Real-World Walking in Multiple Sclerosis Examined, Gait Posture; ePub 2017 Oct 14; Engelhard, et al

Must Reads in FDA Actions

FDA Approves Soliris for Generalized MG, Alexion news release; 2017 Oct 23

FDA Approves Lyrica CR Extended-Release Tablets CV, Pfizer news release; 2017 Oct 12

FDA Approves Antiepileptic Drug for Age 4 and Older, Sunovion news release; 2017 Sep 14

FDA Approves Spinal Cord Stimulator for Chronic Pain, Medtronic news release; 2017 Sep 18