FDA Committees Vote No to New Oxycodone IR Formulation

FDA Committees Vote No to New Oxycodone IR Formulation
FDA Committees Vote No to New Oxycodone IR Formulation

In a joint meeting of two Food and Drug Administration (FDA) Advisory Committees, panelists voted against approval of a new immediate-release (IR) formulation of oxycodone (Avridi; Purdue Pharma) with properties intended to deter abuse of the product via IV or intranasal routes and voted for approval of a new extended-release (ER) formulation of oxycodone (Xtampza; Collegium) with abuse-deterrent properties. 

On September 10, 2015, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) voted 23 to 1 against approval of oxycodone IR for the management of pain severe enough to require an opioid analgesic and for which alternative options are inadequate. The proposed label instructed patients to take the tablets on an empty stomach due to results from a study that found an average 27% lower maximum concentration for oxycodone IR compared to oxycodone HCI when the drugs were taken with food. The Committee expressed concerns that patients may not be able to comply with taking the medication every 4–6 hours on an empty stomach and did not feel that the labeling instructions would sufficiently mitigate this risk. In addition, for patients taking concomitant medications with food-related dosing requirements, this requirement could be difficult.

RELATED: FDA Committees to Discuss Potential Dosing Error for New Oxycodone IR Formulation

The Committees also met today to jointly discuss Collegium's New Drug Application (NDA) for oxycodone ER capsules with abuse-deterrent properties. The proposed labeling for oxycodone ER included that the product must be taken with food in order to deliver the intended amount of oxycodone. The Committees evaluated the potential safety and efficacy and fluctuations in oxycodone levels if the drug is not consistently administered with food and voted 23 to 0 in favor of approval. 

While the FDA is not bound to the recommendations, the agency typically follows the advice of the advisory committees.

For more information visit FDA.gov.

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