James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Managed Healthcare, in “FDA Challenges Abuse-Deterrent Opioid Drug Claim,” by Tracey Walker.
Following is an excerpt:
The FDA is pushing back on an abuse-deterrent claim by an opioid drug candidate.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Committee wants to review additional safety and efficacy data for abuse-deterrent oxycodone hydrochloride extended-release (ER) tablets (Rexista). Rexista is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
This decision is not that surprising, says James Boiani, a member of the firm Epstein Becker Green’s Washington, D.C., office.
“In July of this year, the FDA presented the Rexista application to FDA advisory committees which concluded by a wide margin that abuse deterrence claims made in the application had not been proven,” Boiani says. “More broadly, though, what is happening is that the FDA and committee members are strictly scrutinizing claims about abuse deterrence in response to the opioid crisis and, I think, lingering concerns that the addictiveness of previously approved opioids was not adequately communicated to physicians or patients. No one wants a product coming out with implied promises of preventing abuse that gives a bump to opioid prescribing without knowing with certainty that it will actually help deter abuse.”
