Collegium Pharmaceutical Inc.'s label for abuse-deterrent Xtampza ER (oxycodone extended-release) didn't change much from what the FDA tentatively OK'd in November, CEO Michael Heffernan told BioWorld Today, saying that the cost will be disclosed later. "We haven't given a price yet for competitive reasons," he said, but "we're not going to put a price out there that's significantly lower or significantly higher than Oxycontin. We'll be in the range."

Purdue Pharma LP, of Stamford, Conn., sells Oxycontin (oxycodone hydrochloride) for pain, a $2.5 billion market.

U.S. regulators cleared Canton, Mass.-based Collegium's Xtampza ER capsules, a twice-daily drug, for pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The product was designed using Collegium's Deterx platform, which involves wax-based microspheres that resist particle size reduction and dose dumping when subjected to breaking, crushing, chewing and dissolving. Xtampza ER's label not only doesn't prohibit but supports dosing the product by sprinkling the capsule's contents on soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

"The FDA made it very clear to us that the label could change, and frankly it did change," Heffernan said, but not drastically. "It was more [about] format and placement. We hoped that we wouldn't have significant changes and we didn't." The compound was approved in five dosage strengths (9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg) and the FDA said it has determined that the "product has abuse-deterrent properties," based on guidance published by the agency in April 2015. (See BioWorld Today, April 2, 2015.)

Heffernan pointed out that the "vast majority of what's on the market today or in development is hard-to-crush tablets. The good news is that, even with that type of technology, we've seen a decrease in abuse with, for example, Oxycontin. That being said, it's still crushable," and such products bear black-box warnings about potentially fatal doses. "Our interest is not just abuse but misuse," he said. "How many patients who can't swallow the pills cut them in half, break them, chew them, grind them, dissolve them, and put themselves at significant risk?" Data in Xtampza ER's label show that "if you chew it or crush it vs. taking it intact, you don't change the pharmacokinetic profile," he said.

"This is our first product so we're launching a new sales force," Heffernan said, and retail sellers will call on pain care specialists. Increased flexibility with the drug "opens up an opportunity in things like long-term care, hospice, cancer-pain clinics, places where people have chronic pain and can't swallow pills," as well, he said. "Today, they don't have a lot of options when it comes to an oral, extended-release product." About 26 million prescriptions are written per year for extended-release opioids "and of that, roughly 5 million are Oxycontin, so there are 21 million prescriptions that aren't tamper-resistant products, aren't abuse-deterrent formulation products," he said.

'BEST IN CLASS' STATUS AHEAD?

Heffernan said three groups of prescribees will be targeted with Xtampza ER. "One is patients who are on immediate-release opioids and who require an extended-release opioid, [but] who can't swallow extended-release opioids. That's not a market that Oxycontin is in today. We think there's also an opportunity [for Xtampza ER] to be used where either patients or physicians no longer use Oxycontin due to stigma attached to it," preferring less-troubled alternatives. "The last will be the doctors who use Oxycontin today and will have to make a decision based on the attributes of the product," he said. "If I want to use extended-release oxycodone, which one should I use? In that case, we will be in a head-to-head scenario with Oxycontin." In an investor/analyst day May 25, "we will go over some data with a head-to-head study with Xtampza ER vs. Oxycontin that is being completed, and we will give more background information on our commercial strategy," he said.

A patent case brought by Purdue against Collegium was dismissed in February. Piper Jaffray analyst David Amsellem, in a research report at the time, predicted near-term final approval of Xtampza ER and did not expect any surprises in the label. At an FDA advisory panel meeting, "a key concern was that the Xtampza ER label (which instructs the patient to "take with food") would not be sufficient to drive appropriate patient behavior with respect to dosing (i.e., the risk being an excessive dosing scenario where the patient takes one Xtampza ER pill on an empty stomach, experiences only a minor analgesic effect, and then takes another pill, only this time in the presence of food)," he recalled. "However, the panel made it clear that the proposed labeling should be sufficient to mitigate the risk of this kind of scenario coming to pass, noting that 1) chronic pain patients are generally diligent regarding dosing and administration, and 2) dosing with a meal is not uncommon at all, with some on the panel noting that mealtime dosing is an easier habit to create than dosing on an empty stomach."

With the final approval, Jefferies analyst David Steinberg predicted that Xtampza ER will become the "best in class" abuse-deterrent opioid. "Given modest initial launches in the pain category in recent years, we forecast sales of $7 million in the second half of 2016 and $41 million in 2017, the first full year of Xtampza ER's rollout," he wrote in a research report. "Over time, however, with what appears to be a superior abuse-deterrent profile, Xtampza peak sales could approach $500 million based on a modest 15 percent penetration of the extended-release oxycodone market and pricing similar to Oxycontin."

Collegium's stock (NASDAQ:COLL) closed Wednesday at $18.09, down 34 cents.

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