PMRS Urges FDA to Block Abuse-Deterrent Opioids

The Pharmaceutical Manufacturing Research Services (PMRS) asked the FDA to block pending and future drug applications for opioids with abuse-deterrent labeling and proposed indications or labeling suggesting the drug is suitable for chronic use, including Pain Therapeutics’ Remoxy.

PMRS argued that opioids designed to deter abuse should not be approved unless there is a “meaningful demonstration” of its abuse deterrent properties within defined legal standards, as opposed solely to methods offered in FDA guidance.

The PMRS claimed that the FDA’s decision to approve opioid drugs for treating chronic pain without adequate evidence of efficacy is the driving factor behind the opioid epidemic.