Pharmaceutical Business review

King says FDA endorses new Skelaxin label

The new labeling includes revised “Precautions” and “Clinical Pharmacology: Pharmacokinetics” sections.

Skelaxin is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties.

Skelaxin does not directly relax tense skeletal muscles in humans. The most frequent reactions to Skelaxin include nausea, vomiting, gastrointestinal upset, drowsiness, dizziness, headache, and nervousness or “irritability.”