FDA Approves Abuse-Deterrent Opioid
Walter Eisner • Thu, March 2nd, 2017
The FDA has approved a new extended-release opioid with abuse-deterrent properties.
This is important for orthopedics. For instance, patients with long-lasting, chronic back pain, particularly after multiple surgeries, are sometimes prescribed opioid or narcotic medications. In fact, one study cited by WebMD, showed that as many as 70% of back pain patients receive opioids. These drugs act on pain receptors in the brain and nerve cells to alleviate pain.
The Centers for Disease Control and Prevention estimates that 78 Americans die every day from an opioid overdose.
New Drug Application Approval
On January 9, 2017, the FDA approved the NDA (New Drug Application) for Egalet Corporation’s Arymo ER (morphine sulfate extended-release tablets). The drug is approved to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Arymo ER is formulated to give it physicochemical properties expected to make abuse by injection difficult. However, abuse by the intravenous, intranasal, and oral routes is still possible.
Reducing Risk and Abuse
According to the company's FDA application, Arymo ER tablets are "extremely hard, resistant to particle size reduction (PSR), and inhibit attempts at chemical extraction of the active pharmaceutical ingredient (API). In addition, the technology results in a viscous hydrogel on contact with liquid, making the product very difficult to draw into a syringe.”
"These features are intended to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain as well as intentional abuse via alternate routes of administration (i.e., manipulated oral, intranasal, intravenous)."
Egalet plans to launch Arymo ER, approved in three dosage strengths: 15 mg, 30 mg and 60 mg, in the U.S. in the first quarter of 2017.
More to Come
The same FDA advisory panel that recommended Egalet's drug also recommended the FDA approve a long-acting opioid made by Teva Pharmaceutical Industries Ltd, Vantrela ER.
It also recommended approval of a long-acting, abuse-deterrent opioid made by Pfizer Inc,, Troxyca ER, although it had reservations about the drug's ability to curb all forms of abuse.
To read more about the drug from the company, click here