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 the possibility of liver damage. In fact, the acetaminophen–the active ingredient in Tylenol and other over-the-counter pain relievers–is the leading cause of acute liver failure in the U.S.
An FDA advisory committee in June 2009 recommended that the agency take action to mitigate the risk of liver toxicity associated with the use of over-the-counter acetaminophen. Those recommendations included reducing the maximum nonprescription dose from 1000 milligrams to 650 milligrams; switching the 1000 milligram dose to prescription status; and eliminating prescription combinations containing acetaminophen and an opioid drug. The FDA hasn’t taken any action on those recommendations as yet. Cadence has said it believes its drug will be approved despite safety concerns about OTC and combination products.
Cadence also said today that the FDA accepted the name Ofirmev for the drug. The company had intended to market the drug under a different name, Acetavance.
Cadence CEO Ted Schroeder continued to sound positive about the drug’s future. “Cadence is committed to making this important new medicine available to patients and will continue to work closely with the FDA and our third party manufacturer to ensure that the observations are addressed as quickly as possible,” he said in a statement.