Egalet Announces Update On Clinical Development Plan For Abuse-Deterrent Morphine Egalet-001

Egalet Corporation

(Egalet) today announced an update to the clinical development plan for Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. Based on the clinical data generated thus far, the Company will need to conduct additional clinical trials to strengthen the new drug application (NDA) for Egalet-001. Egalet plans to schedule a meeting in the fourth quarter of 2014 with the U.S. Food and Drug Administration (FDA) to discuss the totality of the clinical data from the studies completed and the appropriate registration path forward for Egalet-001. Egalet received topline results from study 067-EG-006, a single dose, open label, crossover pharmacokinetic (PK) study of Egalet-001 15 mg compared to MS Contin® (morphine sulfate controlled-release) 15 mg in 64 subjects in a fasted state. The study showed that: Egalet-001 met the bioequivalence criteria (90 percent confidence interval of 80 to 125 percent) on the measure of area under the curve (AUC) with a ratio of 95.12 percent (90 percent confidence interval of 91.01 to 99.42 percent); On the measure of maximum plasma concentration or Cmax, the ratio of Egalet-001 to MS Contin was 83.6 percent and was within the range necessary for bioequivalence (80 to 125 percent), however the 90 percent confidence interval was 78.99 to 88.47 percent, outside the range necessary for bioequivalence (90 percent confidence interval of 80 to 125 percent); and Egalet-001 was well tolerated and no serious adverse events were reported. "The results of our studies to date increase the likelihood that a Phase 3 study will be needed to provide us the highest probability of success of bringing Egalet-001 to the market which extends our anticipated NDA submission to mid-2016," said Bob Radie, president and chief executive officer. "We will continue to work closely with the FDA to determine if there is a faster approach to support our NDA submission for Egalet-001." As previously announced in August, planning for the Phase 3 trial that will examine the efficacy and safety of Egalet-001 in individuals with chronic low back pain has begun and enrollment is expected to start in the first quarter of 2015. "There have now been five clinical studies which have shown consistent AUC results—one of the major pharmacokinetic indicators of efficacy for chronic pain medications—within the range of bioequivalence when comparing Egalet-001 to the reference drug MS Contin," said Jeff Dayno, MD, Egalet's chief medical officer. "While we are continuing to move our Phase 3 program forward, we are analyzing all of the data from our PK trials to further understand the findings and to assess whether a bioequivalence approach for the NDA submission is viable."