Thursday, Cadence Pharmaceuticals, Inc. (CADX) announced that the FDA has issued a Complete Response letter to its New Drug Application for intravenous pain killer IV acetaminophen due to deficiencies in the facilities of the company's third party manufacturer.
In its Complete Response letter, the FDA indicated that it observed deficiencies during its facility inspection of Cadence's third party manufacturer completed last week. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval.
Cadence said its third party manufacturer intends to respond promptly to the observations. The company also has plans to request a meeting with the FDA to ensure that it addresses the deficiencies and meets the requirements for NDA approval.
The FDA has also informed the company that Ofirmev is an acceptable trade name for IV acetaminophen. Ofirmev is supposed to help with the management of pain and the reduction of fever in adults and children. Acetaminophen is used in the U.S. in treating pain and fever and Ofirmev is Cadence's proprietary intravenous formulation of acetaminophen.
The NDA for Ofirmev includes data from two pivotal clinical trials for the treatment of acute pain in patients following orthopedic surgery and abdominal laparoscopic surgery and one pivotal clinical trial for the treatment of fever.
CADX is currently trading at $9.53, down $0.75 or 7.39%, on a volume of 1.20 million shares on the Nasdaq.
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