When we last reported in May about Egalet Corp., the firm was on track for FDA approval for Egalet-001, an abuse-deterrent oral morphine-based pain reliever.

On July 15 the company announced positive results from its Category 1 abuse deterrence study for the drug.

In the comprehensive laboratory study Egalet-001 demonstrated resistance to common forms of physical and chemical manipulation as compared to MS Contin. Egalet-001 resisted crushing in order to swallow, snort or smoke, and dissolving in order to inject – one of the most common methods of abuse of morphine-based products.

Egalet-001 displayed resistance to crushing, grinding and thermal stressing and tablets resisted all extraction attempts and maintained extended release characteristics. Extreme gelling occurred with all aqueous solvents, indicating Egalet-001 will not be injectable.

“The study supports Egalet-001’s strong abuse-deterrent characteristics including, importantly, preventing the ability of the active pharmaceutical ingredient from being drawn into a syringe to be injected which is one of the most common methods of morphine abuse,” said Edward J. Cone, Ph.D., principal scientist for drug delivery and abuse deterrent drug products at Pinney Associates.

“With prescription medication abuse as the number one cause of accidental death in the U.S., it is critical that we have prescription medicines that deter abuse and Egalet-001 demonstrates real promise to help fill that need.”

“With these positive Category 1 abuse deterrence study results, we continue to differentiate Egalet-001 from currently available oral morphine products,” said Bob Radie, Egalet’s president and chief executive officer. “Although no abuse-deterrent formulation is expected to prevent all forms of abuse, Egalet-001 is expected to present significant barriers to physical and chemical manipulations for purposes of abuse. With the ongoing prescription opioid abuse epidemic in the United States and no currently available abuse deterrent morphine-based products, we want to help safeguard against the unexpected and develop Egalet-001 to fill the void in the market.”

Egalet-001 is Egalet’s lead product candidate. There are currently no commercially available abuse-deterrent formulations of morphine, and Egalet-001, if approved, could fill a significant unmet need in the marketplace. Egalet plans to submit an NDA for Egalet-001 in the fourth quarter of 2014.

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