San Diego-based Cadence (NASDAQ: CADX) disclosed two weeks ago that the FDA could not approve the company’s pain reliever because of manufacturing problems, but the company didn’t provide any details. Now the FDA inspection report on the manufacturing plant has surfaced—and the details aren’t pretty.
The FDA found numerous deficiencies in the production process and discovered that one of three batches of Cadence’s intravenous acetaminophen was contaminated with a piece of nylon, three PETs (a polymer used to make bottles or clothing) and human skin. The drug is being produced for Cadence by Baxter Healthcare, a unit of Baxter (NYSE: BAX), at a factory in Cleveland, MS.
Intravenous acetaminophen is intended to be Cadence’s flagship product. Cadence licensed the drug from Bristol-Myers Squibb (NYSE: BMY), which sells intravenous acetaminophen in Europe under the name Perfalgan.
Cadence hopes to market the drug to hospitals in the U.S. 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. It should be noted that while acetaminophen isn’t addictive, it can cause liver damage.
The FDA inspection report states that Baxter must sequentially produce three acceptable batches of intravenous acetaminophen in order for the drug to receive FDA approval. So far, it seems, Baxter has failed to do so.
The report states: “The firm did not successfully produce three sequential batches for NDA submission nor did they (sic) process … Next Page »