(Refiles to fix typographical error in headline; Adds panel
member, company comments)
By Lisa Richwine
GAITHERSBURG, Md. Nov 13 An experimental
painkiller from King Pharmaceuticals Inc KG.N and Pain
Therapeutics Inc (PTIE.O) appears less susceptible to abuse
than similar drugs, most members of a U.S. advisory panel said
A majority on the Food and Drug Administration panel said
they felt the companies had shown Remoxy was less vulnerable to
abuse than painkillers such as Purdue Pharma's Oxycontin. Eight
The FDA will make a final decision on whether to approve
Remoxy. The panel's chairman said the members' views were not a
formal vote as the agency had not requested one.
Some analysts forecast Remoxy sales to exceed $1 billion
annually if the drug wins approval.
The FDA had asked for advice on whether Remoxy was
different enough from other narcotic drugs to conclude it would
be abused less and how much information about tamper-resistance
should be included on prescribing instructions.
Agency officials said the panel appeared to struggle with
where to set the threshold to call a drug abuse-resistant, one
of the key questions the agency is grappling with internally.
"The message is that there are not a lot of answers to
these very difficult questions," Dr. Bob Rappaport, director of
the FDA division that reviews painkillers, said after the
Drug abusers often crush Oxycontin to snort or inject it
and get a quick high.
The FDA, which wants to maintain painkiller access for
patients who need it while minimizing misuse, has encouraged
companies to develop abuse-resistant alternatives. That task
"has proven to be more challenging than any of us would have
imagined," Rappaport said.
The Remoxy capsules contain a thick gel and were designed
to resist crushing, dissolving into a liquid or other forms of
The drug is not abuse-proof, Pain Therapeutics officials
said. But various laboratory tests showed it was more difficult
and took longer to extract a smaller amount of oxycodone, the
active ingredient, when compared with Oxycontin.
"We believe we met our objective in showing Remoxy resists
abuse by the oral route, snorting, injection and smoking,"
Michael Zamloot, a senior vice president for Pain Therapeutics,
told the panel.
Some panel members called for more study to see how drug
abusers would actually use it.
"We have no idea what this drug would do in all sorts of
people," said Dr. Sidney Wolfe, head of Public Citizen's Health
Research Group, a consumer group.
Pain Therapeutics, which has no FDA-approved products on
the market now, would receive 15 percent royalties from Remoxy
sales if it is cleared. King would handle marketing.
The drug is "a first step in developing an innovative
medicine designed to strike a balance between the need for
effective pain control and the need to minimize risks" with
current options, James Green, a King executive vice president,
said in a statement.
The FDA usually follows panel recommendations when deciding
whether to approve new drugs. A decision is due by Dec. 10.
King is seeking to expand its pain management franchise by
making a hostile bid to buy Alpharma Inc ALO.N for about $1.6
billion. On Friday, an FDA panel will consider Alpharma's
experimental painkiller, Embeda, on Friday.
(Editing by Andre Grenon)