The new Securel patent application is entitled "Multimodal Abuse Resistant and Extended Release Opioid Formulations." Once granted, the patent is expected to be valid until at least 2028.
Relmada’s lead development program, LevoCap ER (REL-1015, levorphanol extended-release, abuse deterrent capsules), is the first product candidate utilizing the Securel technology platform. The patent contains claims that provide broad coverage for levorphanol and other opioids that could leverage the Securel technology platform.
"These newly allowed claims strengthen Relmada’s overall patent portfolio," said Sergio Traversa, CEO of Relmada Therapeutics.
"With this new patent protection and levorphanol’s broad spectrum activity, LevoCap ER could be well positioned commercially in the chronic pain treatment market, if approved. We look forward to initiating a Phase III study with LevoCap ER as soon as feasible following interactions with the Food and Drug Administration (FDA) with respect to the end of Phase 2 meeting expected to take place before the end of 2015."
Recent experience with extended release opioid pain relievers has shown that intentional crushing or extraction of the active ingredient from the dosage form by addicts and recreational drug users can destroy the timed-release mechanism and result in a rapid surge of drug into the bloodstream. Serious side effects and death have been reported from such misuse.