Cadence Pharmaceuticals had to wait a little longer than it wanted, but today it got its wish.
The San Diego-based biotech company (NASDAQ: CADX) said today it won FDA clearance to start selling an intravenous form of the pain reliever acetaminophen (Ofirmev) for use in hospitals. The drug, known in its over-the-counter form as Tylenol and Excedrin, has never cleared for sale before as an intravenous form in given in U.S. hospitals.
The approval is a big deal for Cadence, because this represents its first marketable product in the U.S. It’s also a mark of perseverance, given the company suffered two regulatory delays in the past year. The new treatment offers an alternative for patients who can’t take oral pain relievers in the hospital, and provides medical personnel another alternative to opioid-based pain relievers that can be addictive and cause serious side effects, like chronic constipation.
Cadence now plans to introduce its new drug to the U.S. market before the end of March, CEO Ted Schroeder said in a statement. Cadence doesn’t have the European rights to the drug, although acetaminophen is approved there, and has the most market share among injectable pain relievers in hospitals, Cadence said.
“The approval of Ofirmev is a significant milestone for Cadence as we advance our mission to improve the lives of hospitalized adults and children,” Schroeder said in the statement.
The last time I talked with Schroeder in depth about the market potential of the IV acetaminophen, a lot of things were different, including the drug’s brand name. At that time, Wall Street was ballparking the price at $8 a dose, and the overall market opportunity in the U.S. at about $500 million. Cadence’s market research at the time suggested that as many as 70 percent of patients undergoing surgery complain that existing drugs don’t control their pain well enough, and the company was hoping to position its treatment as a safer alternative.
Cadence plans to discuss the approval and its commercial plans on a conference call with investors at 5 pm Eastern/2 pm Pacific today.
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