Egalet's ($EGLT) in-development pain pill met its goals in a study designed to prove its abuse-deterrence, beating out a rival treatment from Purdue Pharma as it heads toward an FDA filing.
The drug, Egalet-001, is a formulation of morphine equipped with a proprietary technology the company says can make painkillers harder to abuse. And in a trial on 46 recreational opioid users, Egalet-001 proved to be significantly less enjoyable to snort than Purdue's MS Contin, a controlled-release morphine pill.
In the study, patients who took powderized Egalet-001 reported significantly lower "drug liking" scores than those snorting ground-up MS Contin, meeting the trial's primary endpoint. Egalet's drug also posted a statistically significant improvement on the secondary measures of "overall liking" and "take drug again," demonstrating a profile similar to placebo, the company said.
That marks Egalet-001's third success in a so-called human abuse liability trial--required by the FDA for powerful painkillers--as the pill previously met its goals in studies of its crushability and abuse potential when swallowed.
With its clinical program now concluded, Egalet is on track to file its lead drug for FDA approval in the fourth quarter, according to management. The agency has bestowed its fast-track designation on Egalet-001 promising more frequent access to FDA staff and making the drug eligible for a truncated review.
Egalet went public in 2014 on the promise of Guardian, its in-house formulation technology that makes pain drugs tougher to abuse. The company is also at work on Egalet-002, an extended-release oxycodone for chronic pain, and a Phase I hydrocdone treatment partnered with Shionogi.
But the Wayne, PA, company isn't waiting on FDA approval to follow through on its commercial ambitions. Earlier this year, Egalet signed a pair of deals to bring in the nasal spray Sprix and oxycodone pill Oxaydo, two already-approved painkillers it expects to launch in the coming months. The plan is to establish a sales force and build commercial muscle with the two products, CEO Bob Radie has said, all the while laying the groundwork for the future launches of Egalet-001 and -002.
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