Cadence Pharmaceuticals’ plans to market an intravenous form of acetaminophen received another regulatory setback today. The FDA told the San Diego-based company that it could not approve the drug because of manufacturing problems at a plant where the drug is made.
The company’s shares dove nearly nine percent to close at $9.46.
Cadence (NASDAQ: CADX) said that the FDA discovered the problems during an inspection of the facility on February 5. The factory is operated by a third party manufacturer, which intends to respond promptly to the FDA, Cadence said.
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. That’s a sign the setback could be temporary.
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. Patients recovering from abdominal surgery can’t swallow the acetaminophen pills or capsules that are currently available.
Cadence plans to position its drug as a safer option to opioid drugs. However, acetaminophen also carries side effects, including … Next Page »