Egalet (NSDQ:EGLT) said today that the FDA tentatively approved an expanded label for its Arymo extended-release pain-relief tablets. The new label includes data from a intranasal human abuse potential study and an intranasal abuse-deterrent claim.
The FDA previously excluded this data from Arymo ER’s label due to exclusivity given to another company, Egalet reported. The FDA is slated to give full approval to Arymo ER’s new label when that exclusivity period ends on Oct. 2, 2018.
“Given that extended-release morphine is the most frequently prescribed ER opioid for individuals living with chronic pain and the majority of those prescriptions are in easy to abuse formulations, we believe that strengthening the Arymo ER label to include additional abuse-deterrent data is an important improvement for chronic pain patients and their communities,” Mark Strobeck, Egalet’s COO, said in prepared remarks. “While opioids should be reserved for situations when all other alternative therapies have been tried, when opioids are needed, having abuse-deterrent options is important.”
Egalet’s category 2/3 intranasal human abuse potential study enrolled 46 recreational opioid users and assessed the intranasal abuse potential of Arymo ER versus MS Contin, a non-abuse-deterrent morphine sulfate extended-release tablet.
The study met its primary endpoint, showing that people who crushed and took Arymo ER liked the drug less than those who crushed and took MS Contin. Researchers also showed that people who took a manipulated version of Arymo ER intranasally were less likely to take the drug again compared to those who used MS Contin.
EGLT shares soared in morning activity, trading at $1.26 apiece – up 25%.