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.”

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.