Pain medication fails; Cadence shares fall 60%
A second clinical trial is positive, company says
Saturday, January 12, 2008
Shares of Cadence Pharmaceuticals plummeted more than 60% yesterday
after the company said its intravenous pain medication failed to
curb pain intensity in a pivotal clinical trial.
But the company said that a 2nd of 4 clinical trials it is conducting
was positive, showing that the drug Acetavance, an IV formulation of
acetaminophen, lowered fever. And the company said it remains positive
about results it expects to receive by the second half of the year on
the drug's use for pain in patients who have had laparoscopic surgery.
"Based on the safety results and secondary endpoints met (for pain relief),
we are strongly committed to the development of Acetavance for acute pain
and fever," Chief Executive Ted Schroeder said.
Shares closed around $14 Thursday and dropped $8.63 yesterday to close at
$5.36, a 52-week low.
The pain trial involved 331 patients hospitalized for abdominal
gynecological surgery who received the drug immediately after the operation.
Its primary goal was to gauge patients' pain intensity when they woke up.
The company believes the trial didn't show statistically significant results
because of substantially higher-than-expected variability in pain intensity
scores in individual patients and from one patient to another, Chief Medical
Officer James Breitmeyer said.
Schroeder said a secondary measure of the trial - the pain relief patients
felt in the 48 hours after surgery as they received more of the drug -
showed Acetavance effective.
The company plans to request a meeting with the Food and Drug Administration
to seek guidance on the path it should take for further development, he
said.
Meanwhile, the company is more confident with an ongoing trial that will
measure the pain relief from Acetavance in patients who have had
laparoscopic abdominal surgery, he said. That trial was designed after
Cadence had already received some preliminary information from the first
pain trial. Reduction in pain intensity will begin to be measured one day
after surgery in that trial, Schroeder said.
For pain relief, federal regulators wanted Cadence to provide data from two
pivotal trials, one in people who have had some sort of orthopedic surgery
and another on people suffering with soft tissue pain.
The company hopes the ongoing trial with laparoscopic surgery patients will
satisfy the soft tissue trial requirement. A previous trial funded by
Bristol-Myers Squibb on patients who had knee or hip replacement will be
submitted as the second clinical trial, Schroeder said.
Cadence licensed the drug from Bristol-Myers Squibb.
The company was aiming to file a new drug application with the FDA by the
end of the year. But that timing was dictated by the company's ability to
obtain data proving the product could be consistently manufactured,
Schroeder said.
"There certainly still is a scenario in which the 2008 filing is possible,"
Schroeder said.
If the FDA wants another pain trial conducted, it would take about 8 months
to complete, which could push the new drug application filing to early 2009,
he said.
Cadence plans to seek approval for Acetavance for post-operative pain relief
and fever reduction. The target market is people who are unable to take
acetaminophen by mouth or who need the drug to take effect more quickly.
Cowen and Co. analyst Leland Gershell said he was "somewhat surprised" by
the failure of the pain trial in its primary efficacy endpoint, given that
Acetavance has demonstrated significant pain reduction in numerous trials
that supported regulatory approval abroad.
Gershell expected the stock to fall on the news, but pointed out that the
clean safety profile the drug demonstrated is an important benefit, "as this
may serve to relieve concerns on the safety of giving serial doses of IV
acetaminophen over two days."
The analyst said the successful fever trial may mean Cadence can start
marketing Acetavance for this initial use without a change in prior
timelines, but he admitted that marketing efforts for surgical pain relief
may be delayed.
Acetavance represents half of the company's late-stage pipeline. Cadence
is also developing another drug, Omigard, for the prevention of
catheter-related infections.
___ Blue Wave/QWK v2.12
Pain & Drugs 6/6 
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