September 11, 2015
By Mark Terry, BioSpace.com Breaking News Staff
A committee of the U.S. Food and Drug Administration (FDA) recommended against the approval of Purdue Pharma L.P.’s Avridi, a new immediate-release formulation of oxycodone yesterday.
The drug was designed to be a fast-acting, abuse-deterrent version of Oxycodone. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 23 to 1 against the approval. The drug is to be taken every 4 to 6 hours on an empty stomach. Any food would decrease the drug’s effects, which, the panel indicated, would cause patients to take more of the drug, leading to potentially dangerous dosages. Most opioid pain medications can be taken regardless of food intake.
There are currently four products approved that have abuse-deterrent properties in their labels. They are OxyContin (oxycodone extended-release tablets), Targiniq (oxycodone and naloxone extended-release tablets), Embeda (morphine sulfate and naltrexone extended-release capsules), and Hysingla ER (hydrocodone extended-release tablets). OxyContin, Targiniq and Hysingla are all marketed by Purdue. Embeda is sold by Pfizer Inc. .
The FDA was careful to emphasize “that abuse-deterrent opioid products are not abuse proof.” It also quoted from the “Guidance for Industry: Abuse-Deterrent Opioids,” that “most abuse-deterrent technologies developed to date are intended to make manipulation more difficult or to make abuse of the manipulated product less attractive or less rewarding. It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse — swallowing a number of intact capsules or tablets to achieve a feeling of euphoria.”
Purdue Pharma currently sells an extended-release version of OxyContin, which is designed to make it more difficult to crush or snort. The FDA panel, whose recommendation vote is non-binding, found the empty-stomach warning to be unlikely to be followed and posed a safety risk.
The panel decision follows a recent controversial approval by the FDA of the use of OxyContin for children as young as 11. The FDA specifically asked Purdue Pharma to study the drug for safety in children ages 11 to 16, because children have fewer pain medication options.
According to Sharon Hertz, a physician with the FDA’s Center for Drug Evaluation and Research, the only alternate long-acting painkiller for children is Duragesic (fentanyl).
Several pediatric oncologists applauded the decision. This “is going to be tremendously helpful for treating children with cancer pain or pain at the end of life,” said Justin Baker, a pediatric oncologist and hospice and palliative medicine physician at St. Jude Children’s Research Hospital to USA Today.
Others expressed concern about the risk for addiction. Scott Hadland, a specialist in adolescent medicine and substance abuse treatment at Boston Children’s Hospital and Harvard Medical School , cited studies indicating that about one in 25 high school seniors have abused OxyContin, reported USA Today. “Among adolescents who are prescribed OxyContin, a small but significant number are going to become addicted,” Hadland said.
An FDA panel will also be reviewing another opioid painkiller today developed by Collegium Pharmaceuticals. Xtampza is also an abuse-deterrent, extended-release formulation of oxycodone. It is designed to prevent intravenous and intranasal abuse, and uses DETERx technology, made up of minuscule beads of oxycodone in a solution that is stored in a capsule. According to the FDA briefing information, Xtampa’s bioavailability increased as much as five-fold when taken with food.
Purdue, which relied on efficacy data from immediate-release oxycodone (Roxicodone) studies performed prior to 2000, argues that the label regarding food intake should be sufficient. The company did perform four new safety studies on a total of 264 patients.
