Study of oral and intranasal Arymo ER (morphine sulfate) in pain relief published in Pain Medicine- Egalet

Egalet announced that results from a Category 3 oral human abuse potential (HAP) study and a Category 3 intranasal HAP study of product candidate Arymo ER (morphine sulfate) extended-release tablets have been published in Pain Medicine, the official journal of the American Academy of Pain Medicine. These two primary publications of the oral and intranasal HAP studies report that, after manipulation and administration via the oral and intranasal routes, respectively, Arymo ER had a significant reduction in maximum drug liking compared to crushed MS Contin (morphine sulfate extended-release tablets) CII and placebo.

The Oral study highlights include: Manipulated Arymo ER demonstrated a statistically significant reduction in maximum drug liking (Emax) compared to crushed MS Contin; Emax values were 67 for manipulated Arymo and 74 for crushed MS Contin; There was no significant difference in Emax drug liking between manipulated and intact Arymo ER; Overall drug liking and Take Drug Again measures were numerically lower for manipulated Arymo ER compared to crushed MS Contin, but did not reach statistical significance.

For the Intranasal study, top-line results from the study include: After maximal manipulation, Arymo ER demonstrated a statistically significant reduction in maximum drug liking (Emax; primary endpoint) compared to crushed MS Contin; This was seen in both of the Arymo ER arms: manipulated and all particle sizes snorted as well as manipulated then filtered with only the smaller particle sizes snorted; Arymo ER was statistically superior to MS Contin on the secondary endpoints of 'overall drug liking' and 'take drug again'; On the measures of 'overall drug liking' and 'take drug again,' both of the Arymo ER manipulated arms had scores similar to placebo.

Comment: A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA has voted 18 to 1 to recommend approval of Arymo ER (morphine sulfate).