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GASTROENTEROLOGY & ENDOSCOPY NEWS • SEPTEMBER 2014
OIC continued from page 1
‘Whether the [cardiovascular] signal is true or
of opioids would unblock the field for more such medications. Opioid-induced constipation (OIC) “is a real problem,” said Eugene Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University, in Philadelphia. Additional drugs in development “are at a critical point that if the FDA required long-term studies, the market would be very limited.” Many physicians are unaware that these drugs are available, while others have been concerned about cardiovascular risk, said Dr. Viscusi, who noted he has frequently prescribed the two FDAapproved peripherally acting µ-opioid receptor antagonists (PAMORAs), methylnaltrexone bromide (Relistor, Salix) and alvimopan (Entereg, Cubist), with good results. The advisory committee’s conclusion “was the outcome I was hoping for,” he said. “There’s not really enough evidence that these longterm safety trials would be required. I’m now optimistic that additional drugs will become available for a very unmet need in the chronic pain community.”
not, it is a signal about a major complication for
Divided Panel In a close decision following a lengthy meeting in June, 12 of the 24 panelists on the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted against requiring cardiovascular outcomes trials; seven recommended the agency require trials for all PAMORAs and five recommended the agency require trials for alvimopan and similar biologics. The group largely agreed that cardiovascular studies can be conducted as postmarketing surveillance, with the exception of alvimopan, and they should last at least a year to sufficiently assess long-term outcomes. Both alvimopan and methylnaltrexone bromide are approved only for specific situations. Alvimopan is restricted to hospitalized patients with postoperative ileus and capped at 15 doses, and only hospitals that register in the Entereg Access Support and Education (E.A.S.E.) program may offer the drug. Methylnaltrexone bromide is approved for short-term treatment in patients with advanced illness receiving palliative care. Alvimopan’s restrictions stem from data resulting from one clinical trial by former manufacturer GlaxoSmithKline, which hinted at an increased risk for myocardial infarction (MI) associated with the medication. In that study, from the mid-2000s, seven patients taking alvimopan experienced MIs, compared with none taking placebo.
an elective medication, and therefore it must be studied carefully. I do trust that the FDA will come to a fair, equitable decision to this dilemma.’ —Mitchell Cappell, MD, PhD
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