Flex-5 OTC switch candidate?
This article was originally published in The Tan Sheet
Executive Summary
Switch of Rx muscle relaxant Flexeril (cyclobenzaprine HCl) could be closer following Feb. 4 approval of less-sedating 5 mg dose for relief of muscle spasm associated with acute musculoskeletal pain. Efficacy of Flexeril 5 was demonstrated in two seven-day, double-blind, randomized, multi-center trials that showed the drug provided significant relief compared to placebo and caused "significantly less drowsiness than patients taking the 10 mg tablet," product marketer McNeil reports Feb. 4. Affiliated firm J&J/Merck has said the drug could be a switch candidate "some years down the road" (1"The Tan Sheet" Sept. 30, 2002, p. 3). The original 10 mg dose was the subject of a 1999 NDAC meeting, but committee members expressed concerns about patients' ability to accurately self-select for the drug...
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