| March 21
March 21 Advisers to the U.S. Food and Drug
Administration recommended that Titan Pharmaceuticals Inc
treatment for opioid addiction be approved, but were
unconvinced that the company's marketing plan was safe enough,
given the potential for abuse of such drugs.
The panel of advisers, who met in Silver Spring, Maryland to
evaluate the safety and efficacy of Titan's Probuphine, also
echoed concerns expressed on Tuesday by FDA staff, who said it
was difficult to decide if the intended dose of the drug would
be effective enough.
FDA advisers voted 10-4, with one abstention, to agree that
Probuphine be approved, based on its safety, effectiveness and
risk-benefit profile as seen in its clinical studies.
"I think it is a drug that we definitely need and the more
we can put into our (opioid dependence) treatments, the better
for our patients," said Dr. Louis Baxter, one of the panel
Federal data shows that drug overdose death rates have more
than tripled since 1990. In 2008, more than 36,000 people died
from an overdose, mostly caused by opioid painkillers, which
outpaced deaths from heroin and cocaine combined.
Probuphine, a long-acting version of British drugmaker
Reckitt-Benckiser Group Plc's branded drugs Subutex and
Suboxone, is implanted under the skin of the upper arm during a
10-15-minute office procedure for about six months.
"I think Probuphine's safety is adequate, due in part to the
fact that we have an adequate medication already on the market
using implant materials we don't doubt," said another panel
member Dr. Christopher Kratochvil, referring to the implantable,
progestin-releasing contraceptive Norplant.
Probuphine needs to be surgically inserted under the skin,
for which general physicians would need training. Some of the
FDA advisers worried that Titan did not have an adequate plan in
place for this.
"If you're not a surgeon and don't do implants on a regular
basis, you're likely to wind up with a deep insertion, which is
a big problem," one of the panel members said.
Five of the advisers voted "yes" when asked if the
risk-mitigation strategy proposed by Titan sufficiently
addressed the potential danger of abuse and misuse that could
come with the drug's use.
Four voted "no," while 6 abstained, most saying they thought
Titan needed to work better on how it would avoid misuse.
Dr. Edward Covington, the panel chairman, concluded the
meeting saying that there was agreement Titan's drug had a
"great potential utility," but deficiencies remained, in terms
of finding the right dose and working out a risk-mitigation plan
for when the drug goes to market.
The FDA is not required to, but usually takes its advisers'
vote into consideration when delivering a final verdict on
marketing approval of a drug.