As you know, on November 2nd Cadence achieved a significant milestone with the approval by the FDA of OFIRMEV, a proprietary intravenous formulation of IV acetaminophen for the management of mild to moderate pain. The management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever, OFIRMEV is the first and only form of IV acetaminophen to be approved in the U.S.
In our pivotal clinical trials in patients undergoing hip or knee surgery, OFIRMEV resulted in significantly decreased pain intensity and reduced opioid consumption, as well as improved patient satisfaction when compared to placebo.
We firmly believe that OFIRMEV may benefit hospitalized patients by offering physicians a new non-opioid, non-NSAIDs treatment option for the management of pain and fever.
Our commercial leadership team led by Scott Byrd, our Chief Commercial Officer, and Randy St. Laurent, our VP of Sales, is excited about the positive feedback we’ve received about OFIRMEV from thought leaders across the country, as well as from our market research.For example, surgeons and anesthesiologists surveyed in 2009 indicated that they would prescribe IV acetaminophen for more than 70% of patients experiencing post-operative pain. As we have stated previously, we believe that OFIRMEV will achieve robust formulary adoption on the basis of its potential to fill unmet medical needs. In circumstances in which hospitals closely consider pharmacoeconomic benefits, we believe OFIRMEV’s value will be reinforced. In particular, we’re encouraged by the potential to provide hospital formulary committees with published studies of IV acetaminophen that have demonstrated a reduction in opioid consumption, as well as decreased PACU time, post-surgical ambulation time and time to extubation in the ICU. Our preparations for the launch of OFIRMEV early in the first quarter of 2010 are well underway. As we shared with you on Tuesday, immediately following the approval of OFIRMEV we initiated the process of hiring our sales team. Read the rest of this transcript for free on seekingalpha.com