The FDA has approved an agonist/antagonist combination of morphine and naltrexone (Embeda – King) for treatment of chronic moderate to severe pain requiring around-the-clock analgesia for an extended period of time. The addition of naltrexone is intended to prevent abuse of morphine.

Development of abuse-deterrent opioid products, including reformulation of existing products, has become a priority for drug manufacturers and public health advocates. Three available opioid formulations, OxyContin (Purdue), Embeda (Pfizer), and Hysingla ER (Purdue), now include claims of abuse deterrence in their package inserts.

The FDA has approved Xtampza ER (Collegium), a new extended-release, abuse-deterrent capsule formulation of oxycodone, for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Development of abuse-deterrent opioid products, including reformulation of existing products, has become a priority for drug manufacturers and public health advocates. Since our last article on this subject, several new abuse-deterrent opioid formulations have been approved by the FDA, including an oxycodone tablet formulation (Roxybond – Inspirion) that is the first immediate-release opioid product FDA-approved to include claims of abuse deterrence in its labeling. No opioid formulation prevents consumption of a large number of intact dosage units, the most common method of...

The FDA has approved Arymo ER (Egalet), a new extended-release, abuse-deterrent tablet formulation of morphine sulfate, for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Arymo ER can only be marketed to deter abuse by injection because another single-entity, extended-release morphine product, MorphaBond, which has not been marketed to date, has marketing exclusivity for deterrence of abuse by the intranasal route through October 2018.

The FDA has approved a second extended-release (ER) formulation of the oral opioid agonist hydrocodone (Hysingla ER – Purdue) for management of pain severe enough to require continuous long-term therapy and for which alternative treatment options are inadequate. Hysingla ER tablets have abuse-deterrent properties to discourage their misuse.