Egalet Corp (NASDAQ:EGLT) made public the results from its Category 3 human abuse liability study of Egalet-100 showed positive results for severe pain treatment in chronic sufferers. The treatment is a slow-release, morphine-based drug that is ingested orally. It was tested on nondependent opioid users and showed a significantly lower pattern of abuse potential with patients, when compared to MS Contin.
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First Late-Level Study
This is the first time the treatment has been presented in a category 3 formatinvolving the company’s Guardian Technology. Egalet Corp (NASDAQ:EGLT)’s differentiated technology shows how effective the alternative treatment is compared to older, more addictive versions. The cutting-edge matrix design coupled with the unique formulation makes this an exciting development for Egalet. Treatments in this genre are often highly addictive and the company’s product was shown to effectively change that. The drug shows resistance to the characteristics normally found in these treatments and succeeded without adding any pharmacologic agents.
FDA Regulations
The drug was tested under FDA guidance for abuse-deterrent opioids. The testing was a single-center, random, blind, placebo four-way cross over study. It was a direct one-on-one comparison of Egalet Corp (NASDAQ:EGLT)’s product, Egalet-100 and MS Contin. The treatment is oral and was done to determine the abuse concerns with recreational opioid users. Egalet-100 is difficult to chew and thus the study focused on using common kitchen tools to reduce the size and make it easier to ingest. This procedure was a product of the first phase of testing in which the issue of physical tampering was addressed. The scoring system used for these types of tests is the Emax. Egalet-100 scored substantially better than MS Contin. This study was presented, along with the previous phase studies, to PainWeek and will be shared completely with the public later this year.
Technicals
The stock broke out of sideways trading and is at its 52-week high. It is battling a strong band of resistance but if it can build a base here that would be very healthy.