FDA Panelists Nix Purdue's Avridi But Greenlight Collegium's Xtampza ER

FDA Panelists Nix Purdue's Avridi But Greenlight Collegium's Xtampza ER

The FDA has said no-go to Purdue Pharma's plan to bring a new immediate-release oxycodone painkiller to market. But the same panelists have approved an extended-release oxycodone painkiller from Collegium Pharmaceutical.
Purdue's new painkiller, to be called Avridi if approved, was planned as an abuse-deterrent pill similar to its extended-release oxycodone painkiller, OxyContin.
Collegium's Xtampza, also abuse-deterrent, is an extended-release oxycodone medication that apparently will go toe-to-toe in the marketplace against the wildly successful OxyContin.

Purdue takes a knock over Avridi

At a joint meeting of two FDA advisory committees, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Purdue provided massive documentation supporting the benefits, need and safety of the proposed new painkiller Avridi. But the panelists voted 23 to 1 against approval, citing safety and other concerns because of the nature of the drug's composition:
  1. The fact that the drug must be taken on an empty stomach would be "too complicated for patients to manage" and if not followed precisely could lead to an increased risk of adverse effects, including overdose. There are many other immediate-release painkillers available that don't present such potential problems.
  2. As the only immediate-release oxycodone pill on the market with an abuse-deterrence factor on the label, it could give a false impression of the safety of the product.
  3. The drug might cost more on average than existing similar painkillers.
"The problem here is that they have developed something with a beneficial abuse-deterrence property, but the product is inferior to the one on the market from the standpoint of how it will work in the most common patient population that needs it," said panelist Sharon Walsh, PhD, of the University of Kentucky, apparently alluding to chronic pain patients and OxyContin.
Walsh told MedPage Today that it wasn't only the chronic-pain-patient safety risk that weighed against the benefit of abuse-deterrence. Having only one abuse-deterrent product among a vast pool of other immediate-release oxycodone formulations already on the market probably wouldn't impact abuse rates, she said.
"A single product in a big class of products with the same chemical isn't going to make a dent in oxycodone use," she added.

A false sense of security?

Committee chairperson Almut Winterstein, RPh, PhD, of the University of Florida, said the label of abuse-deterrence might give providers "a false sense of safety" where, in reality, it adds a safety concern.
Arthur Kibbe, RPh, PhD, professor emeritus of Wilkes University in Pennsylvania, was the only panelist voting in favor of approval. Kibbe told MedPage Today that it's "not the agency's job" to prevent an item that would have marginal use from the marketplace just because it would cost more and be more complicated for patients to use compared with other immediate-release formulations.
Purdue didn't perform new efficacy trials, relying instead on pharmacokinetic data to establish equivalence to Purdue's original immediate-release oxycodone, Roxicodone, which was approved in 2000.
Steven Passik, PhD, of Millennium Health in San Diego, said he cast an "ambivalent 'no' vote" because "in the end, it's not bioequivalent" to Roxicodone. He added that if an efficacy trial showed that it was bioequivalent, he might change his mind.
According to the FDA, immediate-release oxycodone is more commonly prescribed than extended-release oxycodone, and its use has been on the rise. Annual prescriptions rose from 3.3 million in 2010 to 5 million in 2014, a 52 percent increase over 5 years. Extended-release oxycodone prescriptions have dropped from 1.5 million to 1 million during that period.

The new oxycodone extended-release pill

The two panel committees which met to discuss Purdue's application convened again a few days later to assess Collegium Pharma's extended-release oxycodone product, Xtampza. The panelists voted 100 percent approval for the drug, possibly because of its superior abuse-deterrent properties.
According to the company's press release, Collegium developed Xtampza using a proprietary abuse-deterrent technology it calls DETERx to address common methods of abuse. The company said its preclinical studies and clinical trials show that the contents of the Xtampza capsule "can be removed from the capsule and sprinkled on food, directly into the mouth or administered through feeding tubes, without compromising their drug release profile, safety or abuse-deterrent characteristics."
By contrast, Collegium said, OxyContin OP (also abuse-deterrent) is formulated in hard tablets, and its black box warning label states that crushing, dissolving or chewing "can cause rapid release and absorption of a potentially fatal dose of the active ingredient."
Collegium believes that Xtampza "can address the pain management needs of the approximately 11 million patients in the United States who suffer from chronic pain and have difficulty swallowing" because of the capsule contents varied availability.

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