Egalet Corp (NASDAQ:EGLT) posted positive top-line data from a Phase III study assessing the safety of Egalet-002, developed utilizing an innovative application of the Guardian™ knowhow. Egalet-002 was largely well-tolerated and the occurrence of adverse events reported was normally consistent with outcomes anticipated following treatment with an ER oxycodone formulation.
The details
Bob Radie, the CEO and President of Egalet, expressed that they consider the positive Phase III safety trial result confirms this innovative application of their Guardian Technology which was utilized to advance their abuse-deterrent, extended-release oxycodone, named as Egalet-002. Provided the prevailing concerns of prescription abuse and chronic pain, they continue to believe there is a requirement for offerings like Egalet-002.
The goal of the open-label Phase III trial was to evaluate the tolerability and safety of Egalet-002 for up to 56 weeks in opioid-experienced people with moderate-to-severe chronic non-cancer pain. The objective of the trial was to administer Egalet-002 to around 150 patients for 6 months and at least 50 patients for a year. The study registered 281 subjects at 39 clinical sites in the U.S. who showed a history of moderate-to-severe chronic non-cancer discomfort for six months or more.
Additionally, a Phase 3 study assessing the efficacy and safety of Egalet-002 in people with moderate-to-severe chronic pain is anticipated to be done by year end. Egalet’s Guardian Technology has several applications and has been utilized to advance abuse-deterrent forms of usually abused prescription drugs.
Guardian Technology can be defined as a polymer matrix tablet know-how that uses an innovative application of the well characterized development procedure of injection molding, which leads in tablets that are difficult and hard to manipulate for abuse and misuse. This approach provides the ability to design drugs with controlled-release profiles and having chemical and physical properties that have been shown to resist both rigorous and common methods of manipulation.
