Cadence Pharmaceuticals Pain Reliever Handed Second Regulatory Setback

▤ Summary

In a press release, Cadence said it plans to request a meeting with the FDA to make sure the manufacturing deficiencies are addressed.The FDA did not request additional studies of the drug or raise any safety or efficacy issues, Cadence said.In November, the FDA extended by three months its deadline for completing its review of Cadence’s application to market the intravenous pain reliever.The deadline was extended to give the agency time to review additional clinical pharmacology data Cadence submitted at the request of the FDA.Cadence developed the drug for use in hospitals as an alternative to opioid-based pain relievers, which can be habit-forming and can cause other side effects, such as constipation.

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