Why the FDA Approved Local Firm’s Abuse-Deterrent Opioid

Photo courtesy Egalet

That Egalet Corporation is in the Philadelphia area is due to one man: Robert Radie.

Well, kind of. Radie joined Egalet’s board in March of 2012 as the first U.S.-based employee, having worked in the Philadelphia area since 1991. (Originally a New Englander, he’s from here now.) He successfully led several drug companies that were later acquired, including the Pfizer’s purchase of Vicuron Pharmaceuticals for $1.9 billion.

When he joined Egalet, the company was still based in Europe. It had been founded in Værløse, Denmark in 1995. But after Radie joined, the company eventually moved its headquarters to Wayne.

“One of the attractive aspects of this area is access to talent,” Radie tells Philadelphia magazine. “And you know because of the proximity to larger pharmaceutical companies in the general area from the Philadelphia area into New Jersey… I think also the local advocacy group Pennsylvania Bio is a very active group that is a proponent for the biotech and health services health services industries. So there’s just a lot that that makes this area the right place for a company like Eaglet.”

Egalet got some good news last week week: Its abuse-resistant opioid, Arymo, was approved by the FDA. Radie says the company had prepared for this approval, and the drug will be on the market in the first quarter of this year.

Arymo uses a proprietary technology, called Guardian, that deters abuse. Egalet’s drugs are created with an injection molding, similar to plastic molding, that creates the shell of the pill first before injecting the active ingredient after the shell cools. “I used the term abuse deterrent — and I don’t think any [drugs] are going to be abuse proof,” Radie says. “Our technology confers physical and chemical barriers to the typical way that people would try to manipulate a product at the first step towards abuse and misuse.”

The drug approval didn’t go perfectly for Egalet. The FDA approved Arymo, and will allow the company to say it deters abuse by those looking to dissolve and inject it. But Egalet had hoped the FDA would let it say it deters abuse by those looking to snort it or take it orally. Indeed, the FDA’s advisory panel voted 18-1 to allow the company to say it deters abuse orally, nasally and intravenously. But the FDA overruled its own panel, saying a different drug (MorphaBond) has market exclusivity on the claim it deters snorting until 2018.

Egalet’s shares dropped on the news that it didn’t win the full approval it was seeking, but Radie says he’s optimistic about the company’s future. It is also working on getting approval for additional dosage strengths of Oxaydo, which the company calls “the first and only immediate-release oxycodone designed to discourage intranasal abuse.”

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