Cadence Pharma Launches a 50-Year-Old Product: Acetaminophen

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adence Pharma (San Diego) has crossed a finish line of sorts—launching a product that it has had under development for six years, to be called Ofirmev (acetaminophen). Cadence will market the product to hospital and clinical settings with a sales force of 147, plus 13 field medical science liaisons. The product (which has been in widespread use in Europe for the past decade) has an unusual genesis, especially for a broadly used generic product like acetaminophen, yet represents a dramatic new therapeutic opportunity. Further complicating the story, and completely coincidentally, FDA chose early January to announce that it was requiring black box warnings on the wide variety of products that combine acetaminophen with opioid analgesics, including such well-known brands as Vicodin and Percocet.

Ofirmev’s story starts with research in Europe for injectable acetaminophen, which was commercialized and then eventually transferred as part of a larger acquisition by Bristol Myers Squibb, according to Ted Schroeder, president of Cadence. But when BMS opted out of the analgesic market in the early 2000s, there was no advocate for getting it commercialized in the US. Cadence won the technology in an auction in 2004 and has been conducting clinical trials and development since, gaining FDA approval in November 2010.

Ofirmev is intended to be prescribed alone, or as a combined therapy with opioids. Acetaminophen is used as a combination product for two reasons: to provide “multimodal” pain relief, and to reduce the amount of opioid patients receive. As an oral solid, this combination is widely prescribed. But for patients who cannot take pills—very young children, very elderly, and some surgery patients—an injectable form would be preferable. Some 80 million doses of injectable acetaminophen are consumed annually in Europe, says Schroeder, while declining to provide a market estimate for the US.

Cadence has impressive financial backing in launching its first product: The company had an $100-million offering oversubscribed in December.

A key part of Ofirmev’s rollout is to target clinical settings, says Schroeder. Company statements note that while the bulk of pharma promotional spending is directed at doctors individually or the general public, hospital settings represent “an underserved and compelling opportunity, especially for a biopharmaceutical company commercializing its products through its own dedicated sales force.”

Schroeder says that the timing of the FDA warnings on acetaminophen-opioid oral solids is unfortunate but not unexepected, noting that acetaminophen is a successful, widely used product, and Ofirmev will be the only injectable analgesic without a black box warning.